Job Description:

The Internal Research Monitor provides support for the Research Compliance Program by monitoring clinical trials and following established processes to support compliance with applicable regulations. The Internal Research Monitor conducts a variety of monitoring activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, the hospital's polices and applicable Food and Drug Administration (FDA) and other regulatory requirements.

Responsibilities:

1. Ensures that research is being conducted in compliance with the study protocols, institutional policy and GCP.

2. Reviews protocols and supports development of the study calendar within the OnCore system.

3. Reviews the accuracy, completeness and timeliness of study related records, case report forms and other documents.

4. Reviews study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines.

5. Reviews drug or device accountability, tracking records, and clinical research pharmacy processes. Verifies that appropriate storage, supply, usage, instruction, documentation and disposition processes are in place and followed.

6. Utilizes appropriate monitoring check-lists and report templates to record and report monitoring findings in writing, and communicates such findings to the appropriate parties (Central Research Department management, the principal investigator, and designated members of the regulatory and clinical trials staff.)

7. Regularly reports noncompliance issues to supervisor.

8. Works with supervisor to identify trends and areas for improvements. Helps develop training to address areas of concern.

9. Provides training on GCP, FDA, NIH, Human Subject Protection and necessary regulations, as needed.

10. Assists with training new or junior staff in QA and monitoring practices and techniques as necessary.

11. Supports supervisor in developing, providing and tracking regularly scheduled, ongoing training.

12. Works with Investigators, research staff, administration and IRB to ensure the quality and validity of clinical research data.

13. Supports department in preparing for internal, sponsor or FDA audits.

14. Maintains in strict confidence all confidential information regarding clinical trials and clinical research study sponsors.

Additional Skills & Qualifications:

1. Maintains required knowledge in the areas of Good Clinical Practice, applicable research regulations and the hospital's Policy & Procedures.

2. Other duties as assigned by supervisor.

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.