Primary Duties and Responsibilities

• Submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices.

• Completes forms and generates reports from multiple data sources to comply with the assigned protocals for the study and/or clinical trail.

• Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trails.

• Responds to generally broad data requests and questions.

• Monitors the status of assigned regulatory submissions and amendments from end-to-end.

• Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date.

• Represents the unit in cross functional meetings and provides updates on the status of assigned regulatory submissions.

• Supports the unit in internal and external auditing of regulatory documents.

• Identifies quality and performance improvement opportunities to support efficient workflows.

Qualifications

Qualifications:

• Bachelor's Degree Required

• 3 years relative experience in a research related field required

• Certification In Clinical Research (CCRP) preferred

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.