Clinical Research Associate Job Description: Top Duties and Qualifications

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

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

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 master 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