USC - Clinical Research Coordinator
📋 Role Overview & Responsibilities
Description
Experience Requirements: Bachelor’s Degree required with 4-6 years experience
Prepare, submit and track regulatory documentation, including informed consents, for activation, maintenance, amendments and close-out Provide guidance and subject matter expertise to other members of the regulatory team Maintain documentation in compliance with federal and local regulations Distribute all relevant regulatory materials to local and affiliated sites Educate and advise physicians and staff regarding ethical conduct and protection of human subjects Provide training to investigators and other members of the research staff regarding policies, regulations, content and processes regarding federal and local regulations Participate in monitoring and audits of regulatory files Respond to regulatory reviewers’ requests for clarification Review IRB approved documents for accuracy; file such documents and communicate with all key stakeholders regarding IRB determinations Draft and submit essential reports to the appropriate IRB such as IND safety reports, AEs/SAEs, deviations, ADEERS submissions, consent form changes, etc.
Skills
Clinical Research, Regulatory, Regulatory affairs, Irb, Regulatory submission, Regulatory compliance
Top Skills Details
Clinical Research,Regulatory,Regulatory affairs,Irb,Regulatory submission,Regulatory compliance
Additional Skills & Qualifications
Required: Must have experience in clinical research (2+) Regulatory experience (2+)
Experience Level
Intermediate Level
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
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Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring 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 for other accommodation options.
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