Clinical Research Regulatory Coordinator

Great Opportunity to Join a Growing Team!

Long-Term Opportunity

Competitive Pay!

Required:

• 1+ years of Regulatory Coordinator experience within clinical research

• Experience with oncology, neurology, or cardiology protocols preferred

Responsibilities:

• IRB Submissions to internal and external IRBs, assisting with sponsor investigator FDA submissions, regulatory binder creation, maintenance, and monitor visit support.

• Work closely with the study teams to ensure that clinical trial research studies and documentation are properly maintained during the pre-IRB, IRB, and post-IRB submission phase.

• Preparation of study documents for initial IRB submission, modification, and annual submission responsibility.

• Protocol amendments and modifications to study documents including but not limited to informed consent form, Investigators Brochure, recruitment materials, personnel changes, continuing review/study close‐ out, annual study, and maintenance reports.

• FDA/regulatory document preparation (1572, FDFs, signature pages, etc.).

• Sponsor required documentation and training log paired with amended modifications.

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 for other accommodation options.