Clinical Research Coordinator

Job Title: Clinical Research Coordinator

Job Description

Seeking a dedicated Clinical Research Coordinator to join our team in Austin, TX. This position involves managing multiple sites, with the primary assignment at one location but occasional travel to others.

1.Interprets protocol(s) correctly and completely to ensure consistent compliance with applicable standards and related requirements.

2.Educates patients and healthcare professionals on the study protocol to ensure complete and correct understanding of information.

3.Reviews medical records against inclusion/exclusion criteria to identify potential subjects.

4.Presents information and responds to questions in accordance with standards of professional practice and compliance requirements in relation to matters including, but not limited to, obtaining informed consent.

5.Maintains and prepares lab kits for subject visits.

6.Coordinates subject visit with Investigator Team.

7.Maintains clinical source records.

8.Organizes Investigator Site Files.

9.Ensures call notes and documentation is accurate.

10. Complies with all regulatory requirements, guidelines, and local regulations.

11. Prepares IRB submissions to include but not limited to development of ICF and any supporting documentation required for submission.

12. Prepares Regulatory documents per sponsor requirements (FDA Form 1572, Financial Disclosure forms, etc.).

13. Coordinates and maintains the following logs: Delegation of Authority, Deviation Logs, Enrollment, Study Status Logs.

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.