Clinical Research Associate II
Advanced Clinical - New Haven, CT

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Job Number: 412208

Clinical Research Associate II

Clinical Research Associate II

Bedford, MA or New Haven, CT

6 months extendable contract

SUMMARY OF POSITION:

Working under general supervision, provide clinical guidance, strategy, and support for the development of new technologies, new products, extended product claims, and post-market clinical research and surveillance. Participate in all aspects of ongoing and clinical research programs by planning, developing, and writing clinical protocols; budgeting; recruiting and training investigators; organizing and participating in investigator and FDA meetings; interfacing with investigators, site coordinators, field clinical personnel, and sales representatives; analyze clinical progress reports for scientific and technical accuracy; prepare clinical portion of PMA, 510k, Design Dossier, and IRB/EC submissions.

ESSENTIAL FUNCTIONS: *

Serve as Clinical Study Project leader and Clinical Affairs representative on assigned project teams to develop clinical strategies that support corporate and departmental objectives. *

May design and develop study protocols, case report forms, and informed consent forms ensuring that the study will produce sound and thorough data to support the approval process; seek input as needed from R&D, Marketing, and Regulatory Affairs. *

Provide study management for regulated and unregulated studies to ensure successful conduct of clinical programs consistent with research and development, marketing and regulatory affairs plans. *

May prepare for and conduct on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure study requirements are being fulfilled. Ensures adherence to study timeline and budget. *

Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support assigned product lines and related clinical studies, staying informed about applicable clinical landscapes and trends. *

Establish and maintain effective relationships with external physician advisors and clinical investigators and applicable research staff. *

Select, interview, and recruit investigational sites and investigators to participate in clinical studies. *

Coordinate clinical trial activities with US study teams for domestic clinical studies and OUS study teams for global clinical studies. *

Organize data in systematic manner to allow for efficient and accurate clinical reports. *

Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements. *

Maintain clinical project files to ensure compliance with internal procedures and Federal regulations. *

Assist internal departments and study investigator(s) as needed to write final reports for clinical studies. *

Provide clinical and technical feedback to product development teams during project team meetings. *

Provide support including technical and scientific guidance to investigators and study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials. *

Serve as technical resource to investigators, sales representatives, and other staff members regarding investigational products and protocol. *

Involved in the preparation of documents for publications, submissions and the coordination of submissions with appropriate site staff and Program Manager. *

May be expected to write a draft of the clinical portion of Regulatory submissions. *

Assist in the preparation of Institutional Review Boards (IRB) submissions for clinical studies. *

Participate in the planning of study training meetings (e.g., Investigator and/or Study Coordinator Meetings) *

Coordinate and document on the internal review of protocol deviations and follow-up to ensure appropriate corrective actions are implemented, as appropriate. *

Prepare for, participate in and document independent safety review meetings (e.g., DSMB, Medical Monitor, Clinical Events Committee). Follow-up with field monitors and clinical sites to ensure all recommendations / request for additional information are resolved. *

Maintain Standard Operating Procedures for the department as assigned by management. *

May be required to attend surgeries to ensure protocols are being followed. *

Coordinate with legal to establish publication contract, coordinate medical writing, ensure proper review and approvals.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: *

Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS:

Education and Experience: * A minimum of an Associate's degree (Life Sciences strongly preferred - Animal Science, Biology, Physiology, Nursing, Medical Technology) plus 4 years relevant experience which includes at least two (2) years experience in medical device/drug clinical research; or a Bachelor's Degree in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus 2 years experience in medical device/drug clinical research required. *

A Graduate degree with a demonstrated research background is preferred. *

Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred. *

Prior participation in all facets of clinical studies required. *

Strong technical or clinical background required.

Skills/Qualifications: * Effective written and verbal communication skills in the area of technical/clinical applications. Strong command of medical and surgical terminology. *

Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget. *

Effective analytical and problem solving. *

Ability to coordinate and lead multiple projects simultaneously. *

Knowledge of and experience in experimental design. *

Knowledge of domestic and international regulations concerning the conduct of clinical studies. *

Knowledge of operating room and surgical procedures *

Effective knowledge in searching medical literature and databases for clinical and technical information. *

Knowledge of computerized databases for the maintenance of scientific data. *

Ability to identify issues proactively, identify resolutions and follow through to completion. *

Ability to handle and prioritize multiple assignments in a fast-paced work environment. *

Ability to organize and take initiative when indicated. *

Working knowledge of statistics and statistical methods. *

Strong command of Good Laboratory Practice (GLP) regulations. *

Ability to train others. *

Ability to work under general supervision. *

Ability to work in a highly matrixed team environment.

Skills/Competencies: * Ethics and Values *

Functional Technical Skills *

Customer Focused *

Interpersonal Savvy *

Managing and Measuring Work

Other Skills: * Effective skills in MS Excel, PowerPoint, Word and internet search engines.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Reports to Manager or Director of Clinical Affairs. Interacts cross functionally with R&D, Marketing, Medical Affairs and Regulatory departments.

WORKING CONDITIONS:

Standard office setting and various clinical settings. Domestic travel approximately 20% - 30% required. On-site monitoring expected.

Interested candidates please send resume in Word format to mklee@advancedclinical.com Please reference job code 412208 when responding to this ad.

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