Clinical Research Coordinator

Description:

Responsible for coordinating clinical research studies, facilitating patient participation, and preparing, submitting, and tracking documentation of research studies.

In addition, the CRC will ensure compliance with local and federal regulations, protocols, and safety monitoring through process audits.

The CRC will advise research personnel regarding study design, study procedures, data abstraction, and data storage.

The CRC supports, facilitates, and coordinates daily research activities and plays a critical role in the conduct of the studies.

Prepare IRB (Institutional Review Board) submissions, proviso resolutions, revisions, and continuing reviews utilizing in-depth knowledge of human subject protections, protocol requirements, good clinical practices, and regulatory compliance as set forth by local and federal regulations

Manage all aspects of conducting investigator-initiated studies, multicenter studies, and industry-sponsored trials (maintain essential documents, investigation product accountability, monitor visit oversight, etc.)

Maintain all data and source documentation, adverse event reporting, and essential regulatory files

Review clinical study agreements, protocols, and budgets for feasibility and ensure compliance

Apply Good Clinical Practice (GCP) guidelines and principles of Human Subjects Protection in study conduct to include the screening, recruitment, consent, study visit completion and safety monitoring

Additional Skills & Qualifications:

MUST have at least 1 year of clinical research experience and 2 years in a clinical or healthcare setting. The RN license is preferred but not a deal breaker.

The clinical research experience is the most important skill set that we are looking for along with a bachelors degree.

Must have experience with 21 CFR 50 and 45 CFR 46 regulations

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.