DESCRIPTION:

The Metis Foundation is seeking a Clinical Research Manager to support a protocol in collaboration with two research programs at the Uniformed Services University of the Health (USU) Sciences in Bethesda, MD: the Military Cardiovascular Outcomes Research Program (MiCOR) and the Translational Medicine Unit (TMU).

MiCOR is a program intended to understand the impact of military service- particularly precision medicine, stress, weight-gain, exercise, and pharmacotherapy- on cardiovascular risk. The mission of the MiCOR Program is to enhance the cardiovascular health and well-being of the Warfighter and the DOD community through innovative clinical research using precision techniques. MiCOR has a variety of clinical research studies focused on both the biomedical and behavioral components that contribute to cardiovascular risk and disease. MiCOR is working in collaboration with the TMU for this exciting study.

The TMU was founded in the late 1980’s as the Clinical Pharmacology Unit by Dr. Louis Cantilena, MD, PhD. It is a storied unit with major contributions to medical product development and scientific literature. TMU currently conducts more than a dozen clinical research studies and aims to conduct 2-4 clinical trials a year of novel products to benefit military medicine and to protect and treat warfighters engaged in Multi-Domain Operating environments.

JOB SUMMARY: The Clinical Research Manager serves as a project manager for one or more clinical research projects, developing timelines, coordinating the activities of team members, stakeholders, and collaborating laboratories, organizing meetings, tracking progress, and acting as a contributing author to progress reports as required. The Clinical Research Manager is responsible for assisting the Program Manager (if applicable) and Director of Clinical Operations in providing administrative and operational project oversight for the COVIVA project at MiCOR in order to maximize the effective use of project resources. Specific areas of administrative and operational project oversight include local IRB compliance, regulatory compliance, budget and accounting in collaboration with DCO, sub-award contracts (if needed), purchasing, and personnel management as appropriate. The Clinical Research Manager also offers coordination of clinical research operations and patient safety in consultation with the PIs and program staff.

ESSENTIAL JOB DUTIES: 90% of the time

1. Serve as a project manager for one or more clinical research projects, developing timelines, coordinating the activities of team members, stakeholders, and collaborating laboratories, organizing meetings, tracking progress, and acting as a contributing author on progress reports as required.

2. Assists in facilitating information flow between MiCOR staff, PIs on MiCOR projects, USUHS administration as appropriate and the Metis Foundation.

3. Partners with Metis administrative staff and MiCOR program members in the supervision of MiCOR research support staff.

4. Provides oversight and coordination of USU IRB and regulatory compliance across studies.

5. Assists in the preparation of the requests for contract actions and proposals. Partners with Metis and USU to assure full compliance with all contract requirements, schedules, and provisions.

6. Assists with MiCOR project-level budget management and reconciliation.

7. Provides advice on manpower utilization, workflow, and operational procedures to increase efficiency, productivity, and make overall improvements for the program.

8. Assist with presenting research findings at conferences and talks as needed.

9. Help coordinate manuscript compilation and achieve authorship as appropriate based on publishing guidelines.

10. Coordinate and collaborate with contracted vendors to carry out study details and adhere to timelines and budget.

NONESSENTIAL JOB DUTIES: 10% of the time

11. Coordinates the initiation and planning of purchase orders, supply sources, work orders, and

maintenance and renovation requests.

12. Assists with participant recruitment and data collection as needed.

13. Completes other tasks as needed.

JOB SPECIFICATIONS: Required Knowledge, Skills, and Abilities:

Knowledge of organizational objectives; ability to work completely independently while collaborating appropriately; ability to use sound judgment and critical thinking in solving problems; ability to coordinate many complex systems and programs at the same time; excellent communication and interpersonal skills; preferred medical clinical skills such as phlebotomy, ECG, medication administration, preferred personnel management experience/ expertise.

Minimum Education/Training Requirements: Bachelor's degree or higher in scientific field and/or medical license preferred.

Minimum Experience: 3 to 5 years related experience in the field of degree or scientific programming. Experience in Clinical Research Trial Management is preferred; Cardiology specific experience preferred.

Physical Capabilities: N/A

Required Licenses, Certification or Registration: N/A

Supervisory Responsibilities/Controls: Partners with Metis, USU,vendors and MiCOR in the supervision of support staff, as appropriate. Strong personnel management experience is preferred.

Work Environment: Office and laboratory setting; Hybrid work schedule; possible evenings and/or weekend hours to accommodate participant schedules

Must be able to obtain a security clearance.

The Metis Foundation is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If hired, must be able to produce proof of identity and legal authorization to work in the United States.