• Quality Assurance Specialist (Senior Clinical Research Associate)

CRS is seeking a Quality Assurance Specialist (Senior Clinical Research Associate) with an understanding of GCP/ICH and SOPs/Standard Operating Procedures to join our growing team in support of NIH. Join our growing team and let's defeat cancer in our lifetime.



Provide assistance in development and implementation of comprehensive QA/QC Program related processes and procedures ensuring compliance with SOPs, data integrity, and security:





Perform quality review of clinical database design, functionality, and timeliness to ensure databases are developed in adherence to the protocol requirements, FDA regulations, GCP/ICH, and company SOPs.

• Provide quality oversight of data review in databases. Ensure quality of data generated from clinical sites and assist in resolving data discrepancies

Review and analyze monitoring findings; Identify and report trends; suggest improvement to ensure high quality of conducted monitoring/audit.

Provide orientation and training to Program staff in data quality review

Develop and maintain SOPs related to QA/QC Program functional areas

Develop and maintain database of QA/QC findings

Analyze QA/QC findings and provide reports to management and NCI customer

• Identify trends that are attributable to systems, and clinical issues. Suggest improvements and assist with implementation of corrective actions
• Serve as liaison and resource for staff

Requirements:

• Monitor NIH intramural and extramural multi-institutional research protocols and ensure clinical trials are conducted in a timely manner.
• Provide quality control of the data in regards of compliance with regulatory requirements on various NIH research protocols.
• Assure adherence to International Commission on Harmonization (ICH), Good Clinical

Practices (GCP), and Code of Federal Regulations (CFR).

• Assure compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements.
• Development of data handling guidelines in order to check validity of clinical data.
• Assure project and study timelines are met.
• Must have a thorough understanding of clinical research protocols, data collection requirements, and methodologies.
• Must be able to recognize clinical values and possess analytical ability to identify data or patient safety issues.
• Must be able to work independently and with others.
• Position involves moderate traveling

Required Experience:

• RN, MS or BS/BA in Health or Biological Sciences or another health-related field
• Minimum of 2 years of medical, clinical, or research related study or instruction. 5 plus years experience can be substituted for education
• 2 years of prior monitoring experience or equivalent preferred
• Certifications preferred: ACRP or CCRP certification

Preferred Qualifications:

• RN or MS in health-related field, and 3+ years monitoring experience
• Experience in oncology clinical research preferred
• Clinical and/or data management certification (e.g., ACRP, CCRP highly desirable) o Understanding of organs and tissues transplantation processes preferred. o Strong communication skills

o Excellent teamwork

Please be aware that many of our positions require a security clearance, or the ability to obtain one. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

CRS is an Equal Opportunity/Affirmative Action Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or membership in any other group protected by federal, state or local law.

Please be aware that many of our positions require a security clearance, or the ability to obtain one. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

By submitting your r sum for this position, you understand and agree that CRS
Corporation may share your r sum , as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Trials: 1 year (Preferred)
• Clinical Research: 1 year Location: In person

Job Details:

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title: Clinical Research Associate IV (14298554)

Remote

Duration: 12 Months

Pay Rate: $35/hr to $50/hr



Description/Comment:

The Clinical Research Associate (CRA) is responsible for supporting clinical activities to generate clinical evidence that will support product registration and/or product market clearance/approval. This position is part of the Clinical Affairs Department for the Clinical Decision Support business unit and is fully remote.

You will report to the Director of Clinical Affairs. You will be part of a cohesive, high-performing team who supports each other and have an attitude to win-as-one!



In this role, you will have the opportunity to:

• Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
• Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.
• Onsite and/or remote monitoring of data and overseeing corrective actions.
• Drive schedule deliverables to meet the overall study timelines
• Develop and drive centralized processes to optimize instrument device data, reconciliation of instrument data to sample list, identification of protocol deviations and data discrepancies to drive compliance to study protocol(s), applicable regulations, Good Clinical Practices (GCP) and Standard Operating Procedures.
• Partner with data management team to effectively operate within data management plan and data management procedures including the Laboratory Information Data Management System (LIDMS)
• Support clinical team which may include activities related to budget management, processing site compensation, supporting accruals, contract execution, collection and document retention of essential documentation, vendor support activities
• Adherence of PHI protection and GCP

The essential requirements of the job include:

• Bachelor's degree or equivalent in the life sciences, with 4+ years’ work experience in vitro diagnostics (IVD), Medical Device, or Pharmaceutical research; 2+ years’ experience with Master’s degree, or 1+ years with Doctoral degree.
• Demonstrated agility with processes and details, ability to apply critically-thinking, analyze data (using analytical tools), and solve complex problems.
• Ability to work independently and effectively under a fast-paced and changing environment
• Proficiency Microsoft Office Excel and Outlook
• Able to travel 10% or as needed

It would be a plus if you also possess previous experience in:

• Real-world data
• Cardiovascular clinical trials
• Electronic data capture (EDC) system (Medidata) and eTMF system (Florence)
• Clinical research certification (i.e., SOCRA, CCRA, CCRC)

To know more about current opportunities at LeadStack, please visit us at [website]
Should you have any questions, feel free to call me on (415) 868-6741 or send an email on [website]

Job Type: Contract

Pay: $35.00 - $50.00 per hour

Benefits:

• 401(k) matching
• Life insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Work Remote

Position:Clinical Research Associate

Summary:Oversees and reviews site activities for clinical trials via on-site monitoring visits and/or in-house assessments according to the trial-specific monitoring plan. Oversees clinical site activities. Monitors trial records to verify the protection and well-being of study subjects and that reported trial data is adequate, complete, and verifiable from source document data. Reviews site compliance with protocol, Good Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs). Frequent travel to study sites is expected.

Responsibilities:

Performs pre-study, initiation, interim monitoring, and close-out visits according to applicable SOPs, GCP, and FDA Guidelines.

Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data.

Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety and well-being, adherence to appropriate safety regulations, and data integrity.

Provides technical, scientific, and operational guidance to study site personnel on the protocol.

Assists with the tracking and reporting of enrollment and works with the site to identify enrollment issues, barriers, and strategies.

Implements project-specific processes and tools.

Responsible for maintaining or gathering site/project-specific information as directed by the sponsor and project management.

Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation.

Assists other team members with site-specific issues, acting as a liaison between study staff and project staff.

Must be able and willing to travel as the project requires.

Performs other tasks as directed by line management or project leadership.

Minimum Requirements:

This position requires a B.S./B.A. in a health-related or scientific field and a minimum of 2 years of experience in clinical research, or an equivalent combination of education and experience.

Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.

Experience in ophthalmology preferred.

Some experience in field monitoring is preferred.

Ability to travel 60% to 70% of the time.

Skills & Attributes:

Highly customer service oriented.

Quality of interactions demonstrates an emphasis on developing and retaining strong relationships internally and externally.

Competent communication (both written and verbal), personable, able to develop a positive rapport with clinical sites.

Demonstrates analytical and problem-solving skills and appropriate judgment regarding issue identification and escalation.

Strong attention to detail,

Competent computer and organizational skills.

Works well independently and as part of a dynamic project team.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application industries have you worked in?

Work Location: Remote

• Do you want to work with a one-of-a-kind, world-class Clinical Research Site?
• Are you someone who excels in a cross-functional, team-oriented role?
• Are you a multi-tasker who demonstrates personal accountability?

If so, our Clinical Research Associate position might be the right fit for you. Our Research Associates are a team of dynamic doers who are committed to providing first-in-class care to our patients.

This role offers clinical support to our Medical Providers and Research Coordinators during Clinical trials and routine medical office visits. At any given moment, you can find a Research Associate triaging patients, gathering medical history, replacing windshield wipers on a patient s car, performing diagnostic procedures, drawing blood, or entering data. You may see them performing ultrasounds, teaching patients, training another team member, renewing prescriptions, returning patient phone calls, relaying instructions from providers, unpacking boxes, or processing specimens.

As a result of the hard-working nature of our Research Associates, they do a little bit of everything through cross-training. They may cover for a Research Coordinator who is out for an extended time. They may backfill the Administrative Team if necessary. The point is that our Research Associates are flexible, willing to learn and eager to grow with the business.

We are looking for motivated Research Associates who excel in customer service and are enthusiastic about learning how to:

• Perform Bone Density testing
• Proficiency in Continuous Glucose Monitor Systems
• Proficiency in Insulin Pump Systems
• Administer IV Boniva treatments
• Support Providers with Thyroid Ultrasounds
• Support Providers with Thyroid Aspirations
• Phlebotomy
• Handle CLIA waived Lab Equipment
• Patient education

Ready to be part of something bigger than yourself?

We are excited to review your resume and cover letter explaining why you would be a good fit for our unique and fun team.

Please include an email address where we can best reach you in your resume, as that is our first point of contact for applicants.

Job Type: Full-time

Pay: $40,000.00 - $42,000.00 per year

Benefits:

• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off

Experience level:

• No experience needed

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Morehead City, NC 28557: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Trials: 1 year (Preferred)
• Clinical Research: 1 year Location: In person

Morair Medtech, LLC is a medical device company developing endobronchial treatments for lung disease. We are looking for an experienced Clinical Research Associate to join our start-up medical device team based in Seattle. The ideal candidate is a self-starter who thrives in a dynamic small company environment.



The CRA will assist study leadership with clinical studies to ensure compliance with study protocols and applicable regulations, and timely study completion. This position is full-time, in-house (remote and in-office schedule) at the Company’s headquarters in Seattle, WA.



Responsibilities:

• Assist with writing and editing of all study related documents including study protocol, study amendments, informed consent forms, committee charters, monitoring plans, study reports and other related clinical and regulatory documents.
• Engage in new study trial design with cross functional teams.
• Contribute to the development of clinical report forms and CRF completion guidelines.
• Manage clinical study documentation tracking, whether in-house or at CRO.
• Support and/or track complete sets of documents presented (or submitted on behalf of the clinical sites) to ethics and regulatory processes and subsequent tracking of site activation activities.
• Assist with training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials as applicable.
• Serve as a point of contact between clinical site study coordinators and the Morair team.
• Regularly prepare and report on study status to internal Morair team.
• Provides Clinical Trial Manager support for tasks between CRO personnel and Morair.
• Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
• Review source documentation to confirm subject eligibility for clinical trials.
• Track study imaging.
• Work with investigators and site personnel to quickly and effectively resolve discrepancies.
• Review data in database for completeness, queries, provide continuous data review of source documents, case report forms, data reports as appropriate, and interact with Data Management as required.
• Assist CRO and/or CRAs in the field with monitoring related items in prepping for and follow-up on study tasks.
• Assist in reviewing of monitoring reports and tracking of action items.
• Assist with the management of investigational studies from start through study closure.
• Update study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager
• Assist with safety monitoring including preparing supporting documentation for IMM/CEC and/or DSMB, meetings, agenda, data review, presentations, updating relevant trackers as applicable.
• Assist with preparation for any investigator’s meeting.

Requirements:

• BA/BS degree, preferably in scientific or healthcare related field. CRA certification desired.
• At least 2 years of experience in clinical research role for CRA I/II, minimum of 4 years for higher level, preferably in medical device.
• Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
• Must have excellent verbal and written communication skills.
• Superior writing, composition, English grammar skills a must.
• Proficient in Microsoft Word, Outlook, Excel and PowerPoint required.
• Domestic and international travel - Position may require travel up to 10%.
• Ability to work successfully with a variety of internal and external sources.
• Current knowledge of medical device clinical trials design and best practices.
• Proficient knowledge of FDA regulations and ICH guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
• General application of medical terminology (pulmonary specific preferred).
• Knowledge of GCP standards.

Compensation

The salary range in the Seattle, WA area for this position is $85,000 - $110,000 annually for a CRA I-II. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Actual compensation will be dependent on factors, including but not limited to, the individual’s qualifications, experience, knowledge, skills, and abilities.



Benefits

• Medical and Vision
• 401K
• PTO
• Annual bonus dependent on individual and company performance

Job Type: Full-time

Pay: $85,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Experience level:

• 2 years

Medical specialties:

• Cardiology

Schedule:

• Monday to Friday

Ability to Commute:

• Seattle, WA 98103 (Required)

Ability to Relocate:

• Seattle, WA 98103: Relocate before starting work Location: Hybrid remote in Seattle, WA 98103

Please apply with your LinkedIn Profile

Local NA monitoring experience of around minimum 02 to 04 Years From East Coast.
Full Time, permanent, Regionally Home-Based position with around 70 to 75% travel from Apr 2022 Onwards (Based upon COVID-19 travel restrictions)

1. Minimum 02-04 years of local monitoring (multicentric Phase II/III studies) experience.
2. Respiratory and Ophthalmology therapeutic experience is preferable but not mandatory.
3. Identify and qualify potential investigators to ensure that the sites have adequate time and can fulfill their obligation to the study.
4. Responsible for identification & collection of necessary documents to be forwarded to Project Manager/ designee, in order to check the feasibility of site/ investigator and approval from authorities.
5. Prepare or submit or support other colleagues for Regulatory and EC submissions and in the generation of Financial Agreements according to standard and local country practices.
6. Conduct of monitoring visits as per monitoring plan in order to check compliance with study management, protocol & other requirements at all assigned sites.

Job Type: Full-time

Salary: $80,000.00 - $110,000.00 per year

Schedule:

• 8 hour Location: Remote

Overall Responsibilities:

This role will support our Client Engagement Managers (CEM) in onboarding a defined set of clients, currently engaged in Clinical Trials Management System (CTMS) implementation to ensure client expectations and deep client relationships are achieved. This role will provide project-based and administrative support for the implementation project team to successfully orient customers to the CTMS.

Top 3 Daily Responsibilities:

• Partnering with CEMs in administrative tasks to ensure client project plans and administrative support documentation are updated as appropriate, managing invitations, informing CEM of client calls, owning documentation of action items and follow up actions
• Learning administrative tasks within the Site Solutions CTMS technology and support technology to assist in site configuration and readiness in preparation for major milestones within the CTMS system
• Preparing for upcoming client calls to include creating meeting agendas, presentations and managing meeting recordings and post meeting sharing
• Assist in the data entry process required for Tailored Migration Assistance project.

Mandatory Skills/Qualifications:

• 1 or more years of experience in a healthcare setting, sciences or research
• 1 or more years of experience in project management
• 1 or more years of experience working with healthcare technology
• Technical skills in product management software and Microsoft suite
• Strong written and verbal communication skills

Non-Essential Skills/Qualifications:

• Clinical research skills
• Previous CTMS experience

Job Types: Full-time, Contract

Pay: $35.00 - $40.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Clinical trials: 1 year Location: In person

Morair Medtech, LLC is a medical device company developing endoluminal treatments for lung disease. We are looking for a Sr. Clinical Research Associate to join our start-up medical device team based in Seattle. The ideal candidate is a self-starter who enjoys working hard in a rewarding industry with a flexible work environment.

Position Summary:Assist with the management of clinical studies for Morair products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization.

Essential Duties and Responsibilities:

• Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
• Assist with the management of investigational studies from start through study closure.
• Engage in new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
• Contribute to the development of CRFs
• Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the clinical trials, as applicable.
• Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
• Serve as a point of contact between clinical site investigators and the Morair team.
• Work with investigators and site personnel to quickly and effectively resolve discrepancies.
• May be responsible for patient accruals and tracking payments to sites for clinical study programs
• Serve as a point of contact between CRO personnel and Morair.
• Oversee/support CRO and field study monitors, with monitoring related items and follow-up on study tasks.
• Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies.
• Provide continuous data review of source documents, case report forms, data reports as appropriate.
• Assist in review of monitoring reports and tracking of action items.
• Review source documentation to confirm subject eligibility for clinical trials.
• Track and upload study imaging
• Manage clinical study documentation (trial main file and study related tracking).
• Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager
• Interact with data management, as applicable
• Support applications and technical files as needed.
• Assist with preparation for investigators meetings.

Minimum Education and/or Experience*: *

• BA/BS degree, preferably in scientific or healthcare related field. CRA certification desired.
• At least 4 years of experience in clinical research role, with at least 2 years in CRA role, preferably in medical device.
• Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
• Current knowledge of medical device clinical trials design and best practices.
• Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
• General application of medical terminology (pulmonary specific preferred).
• Domestic and international travel - Position may require travel up to 10%, however this is an in-house position.

Job Type: Full-time

Pay: $140,000.00 - $175,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Seattle, WA 98103: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Will you now or in the future require sponsorship for employment visa status (e.g. H1-B visa Location: One location

Role: Clinical Manufacturing Associate
Location: Menlo Park, CA
Duration: 12+ Months
Job Description:
Our client's Pharmaceutical Sciences Department is seeking a Clinical Manufacturing Associate. The ideal candidate shall have cGMP drug product manufacturing experience. Our client is seeking a meticulous Research Associate to be a part of the Clinical Manufacturing group in Menlo Park, CA. We are specifically interested in candidates with hands-on experience working in production areas within Drug Product Manufacturing.
Responsibilities will include

• Maintaining the manufacturing facility and support all manufacturing activities within the GMP manufacturing group.
• Candidate will be required to keep accurate and detailed laboratory and equipment notebooks and records.
• Other responsibilities include setting up and maintaining manufacturing equipment and instrumentation to support projects.
• This is a hands-on position in the manufacturing facility. Candidate should be able to communicate daily results and summarize progress with the supervisor.

Qualifications:
Bachelor of Science (B.S.) in Chemistry, Life Sciences or Pharmaceutical Sciences.
A lower educational credential may be considered if candidate has ample industrial experience.
Experience:
About 3-5 years of industrial experience in manufacturing sciences. Experience with fill/finish and/or solid-dosage production is preferred.
Competencies:

• Candidate must be familiar with cGMP laboratory procedures and good practices.
• Background on equipment set up, cleaning, and changeover is desirable.
• Proficient in MS Office applications (Word, Excel, PowerPoint, Project).
• Candidates should have good problem solving / communication skills, and ability to work in a collaborative team environment.

Job Types: Full-time, Contract

Salary: $25.00 - $30.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Menlo Park, CA 94025: Reliably commute or planning to relocate before starting work (Required)

Experience:

• CGMP: 3 years (Required)
• Laboratory procedures: 3 years (Required)
• Drug Product Manufacturing: 3 years Location: One location

Clinical Research Associate II

Cleveland, OH

SPR Therapeutics, in the Highland Hills/Beachwood area, is a growing, medical device company specializing in pain management through non-narcotic means. SPR Therapeutics is committed to improving the lives of millions of pain sufferers with its peripheral nerve stimulation (PNS) platform technology. This is an excellent and unique opportunity to be a part of clinical studies for game-changing, innovative technology!

We have an opening for a Clinical Research Associate II to lead the coordination and implementation of clinical study activities for product development projects. Works directly with the clinical, research, and regulatory staff to execute clinical studies.

Responsibilities:

• Assists in clinical support and defining clinical and customer requirements for company products as needed.
• Assists Clinical Project Managers and clinical sites in preparing IRB submissions and subsequent IRB amendments.
• Coordinates and monitors clinical studies to ensure compliance with study protocols, regulatory requirements, applicable grant requirements, and Good Clinical Practices. Prepares monitoring reports following study site visits as applicable.
• Manages investigational device inventory and clinical study supplies for all active clinical studies and prepares and manages investigational device and supply shipments to clinical sites.
• Develops study protocols, informed consent forms, case report forms, device manuals, and other study support documentation and provides to clinical sites, as necessary.
• Plans and conducts Investigator Meetings in conjunction with the Clinical Affairs staff.
• Supports, prepares, and maintains sections of regulatory submissions, including IDE's, 510(k)'s, PMA's, HDE's, Technical Files, and Annual Reports, as needed.
• Trains clinical site staff on study protocols, good clinical practices, and use of investigational devices.
• Writes data management plans, designs and develops databases for clinical study data, enters data from case report forms, generates data queries, conducts data analysis, and assists in the preparation of clinical study reports.
• Maintains regulatory binders for all active clinical studies.
• Develops new and revises current Clinical Affairs policies, processes and SOPs as needed.
• Works directly on client consultant projects, generating billable services.
• Provides mentorship and guidance to Clinical Research Associate(s).
• Works with third-party vendors (e.g., EDC vendor) to coordinate and implement various elements of the clinical studies.
• May serve as Clinical Project Manager for smaller studies as needed.

Requirements:

• BS or higher in Life sciences or related technical or clinical field; biomedical engineering degree is a plus.
• At least 2 years experience as a Clinical Research Associate
• Experience with the design, management and conduct of medical device or drug related clinical studies. Knowledge of FDA guidelines and Good Clinical Practices.
• Familiarity or experience with neurostimulation or neuromodulation medical devices is a plus.
• Ability to travel up to 40%
• Ability to handle several priorities within the clinical research process.
• Ability to reason independently and recommend specific solutions in clinical settings.
• Ability to work independently, prioritize, and work within a team environment.

Why Join Our Team?

• Entrepreneurial work environment
• Small, collaborative office environment.
• Competitive compensation and benefits
• Flexible work/life balance
• Wellness Program

Equal Opportunity Employer. Must be legally authorized to work in the United States without sponsorship. Background Check Conducted.

Job Type: Full-time

Pay: From $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental Pay:

• Bonus pay

Ability to commute/relocate:

• Beachwood, OH: Reliably commute or planning to relocate before starting work Location: One location

Avery Therapeutics, Inc. is a leader in the development of next-generation bioengineered therapeutics for cardiac diseases, such as chronic heart failure. Avery's dedicated and passionate team has the unique privilege of making significant contributions to groundbreaking therapies that address large unmet medical needs. As a late-stage pre-clinical company, each member is a difference maker and is paving the path for novel and needed treatments.

Located in Tucson, Arizona, Avery's small team enjoys 350 days of sunshine a year, a warm and caring culture, team outings from hiking to patio happy hours, encouraged professional development, and shared drive to help millions of patients.

Avery is recruiting an experienced Pre-clinical/Clinical Research Associate with deep experience in pre-clinical and early-clinical-stages of product development. The Clinical Specialist will oversee on-site pre-clinical activities at contract research organizations and clinical trial activities at clinical sites, provide guidance to collaborators and bring feedback to the product development, regulatory, quality and clinical teams. This role will be focused on the development of Avery's MyCardia, an epicardially-placed viable cardiac matrix in development for treatment of chronic heart failure.

This is a new role which is well suited for a talented, self-motivated individual, able to work independently but eager to collaborate, and ready to set a new standard at our firm.

In your application, please include a cover letter describing your interest and qualifications, a CV or resume, and any relevant publications.

Position: Pre-clinical/Clinical Research Associate

Timeline: Immediate

Job Location: Tucson, AZ, Grand Rapids, MI, Minneapolis, MN. Frequent travel required.

Compensation: $90,000 - $130,000 DOE

Compensation and Benefits:

Retirement plan with company match

Relocation assistance (if applicable)

Professional development

Desired Skills and Experience:

Pre-clinical development

Pre-clinical models of cardiac disease

Project management

Good clinical practices

Good laboratory practices

Good documentation practices

Clinical trials in cardiovascular field

Implantable medical devices and/or biologics

Duties and Responsibilities:

Frequent travel primarily to Grand Rapids, MI, Minneapolis, MN and surrounding areas. Occasional travel to Tucson, AZ, New York, NY and other locations.

Develop understanding of clinical needs and use of Avery products in the pre-clinical and clinical setting

Create training program and perform training on handling MyCardia to pre-clinical and clinical collaborators

Collect feedback on use of product and communicate to product development team

Provide case support for clinical studies

Prepare clinical literature reviews

Compile, review, document, present, and report to executive team

Assist in development and documentation for clinical protocols, instructions for use, regulatory submissions, etc.

Support company quality and regulatory operations

Oversee pre-clinical and clinical research activities by communicating with study staff, and monitoring (ensure compliance) and documenting progress

Establish and maintain appropriate procedures within the quality system

Develop, document, and revise standard operating procedures and support document control processes

Provide leadership and collaborate with internal and external personnel on research activities

Collaborate with and deliver technical information to team members, company executives, quality consultants, regulatory consultants, CMC consultants, and contract organizations

Maintain and distribute study records, documents, and materials

Perform inspection of sites, activities, and documentation for audit readiness

Prepare reports and publications

Attend and present at clinical and scientific-related meetings

Required:

U.S. Citizen or lawful permanent resident ( green card holder)

5+ years of experience in biotech/medical device industry

Degree in science, engineering, nursing, medicine

Skills in organization, communication, and attention to detail

Experience collaborating with and overseeing work at clinical sites and contract research organizations (pre-clinical and clinical)

Knowledge of Good Clinical Practices, Good Laboratory Practices and Good Documentation Practices

Knowledge of FDA CFRs and relevant guidance documents

Avery Therapeutics is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

Job Type: Full-time

Pay: $90,000.00 - $130,000.00 per year

Benefits:

• Paid time off

Schedule:

• 8 hour Location: Multiple Locations