Join the HJF Team!
HJF is seeking a Clinical Research Manager III to support the Center for Neuroscience and Regenerative Medicine (CNRM) located in Rockville, MD. HJF provides scientific, technical and programmatic support services to CNRM. U.S. citizenship required.
The Clinical Research Manager III will play a central coordinating role in the implementation of clinical research protocols focused on the study of traumatic brain injury in DoD medical treatment facilities. The Clinical Research Manager III will primarily support a multi-site, randomized, interventional trial of non-invasive brain stimulation treatment. Secondary support on interventional trials include additional treatments for sequelae of military traumatic brain injury.
- Interacts regularly with clinical investigators, clinical site coordinators, regulatory and safety monitoring staff, laboratory personnel, data coordination center personnel, data analysts, biostatisticians, program managers and administrative staff. (30%)
- Develops, implements, and oversees clinical research protocols, specifically: (1) management of protocol development activities; (2) oversight and guidance of protocol execution activities at clinical research sites; (3) writing of standard operating procedures and associated documents; (4) coordination of the protocol submission. Ensures project completion and final product development. (25%)
- Serves as the direct supervisor of clinical research site personnel and effectively delegates protocol-specific tasks. (15%)
- Responsible for development/tracking of protocol performance metrics. (10%)
- Coordinates with program managers to write progress reports, review study budgets, set and enforce project timelines, and track various aspects of the program related to research administration. (10%)
- Conducts literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team, and serves as a liaison between review committees and other members of the investigative team. (10%)
- May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.
Required Knowledge, Skills and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects. Experience in the design and conduct of multi-site clinical trials. Prior experience in a clinical research environment and knowledge of biomedical sciences and clinical research. Familiarity with clinical research methods, including studies utilizing randomized controlled trial. Ability to communicate effectively in written and oral form including communicating research findings in presentations and publications. Excellent verbal, written, and interpersonal skills. Ability to establish goals and agendas. Knowledge of Military Medicine, Traumatic Brain Injury, Transcranial Magnetic Stimulation, and/or advanced neuroimaging preferred. Experience with utilization of electronic military medical records and military medical systems preferred. Prior supervision and mentorship of study personnel preferred. Knowledge of PCs including MS Word, Excel, and PowerPoint. Some travel may be required.
Minimum Education: Master’s degree in Neuroscience, Psychology, Public Health, or related field or equivalent experience in education required.
Minimum Experience/ Training Requirements: 9-10 or more years of clinical research experience, with a minimum of 2 years being in a clinical research management position; educational experience may substitute for a portion of this.
Background/Security: U.S. citizenship required; eligible to obtain and maintain a Tier III Investigation/ Secret Clearance.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Location/Region: Rockville, MD