Clinical Research Manager

Develop, manage, and streamline the SEAS-specific clinical research program. Engage with SEAS research teams and faculty to build off of the priorly developed infrastructure at the Wyss Institute (i.

e., responsible for developing, modifying, and implementing standard operating procedures).

• Manage, train, and supervise a team of clinical research coordinators who support. SEAS and its collaborating institutions, industrial partners, and federal sponsoring agencies on physical clinical studies, primarily involving patient populations.
• Conduct internal monitoring of ongoing clinical research studies to ensure protocol. and regulatory compliance with Good Clinical Practices and other applicable regulations.
• Manage in-person clinical and human subjects studies including subject interaction and implementation of study design and controls.

Ensure compliance with Institutional Review Boards at Harvard and collaborating institutions. Activities include, but are not limited to, screening, enrollment, medical clearance, scheduling, protocol modifications, participant transportation and remuneration at numerous test sites.

• For in-person clinical and human subjects studies, oversee corresponding data, database management, and data security in conjunction with SEAS Office of Computing (data security submission, data use agreements, etc.).
• Initiate, prepare and submit documents to Institutional Review Boards (IRBs) and other governing / regulatory bodies, including, but not limited to, reliance agreements, research protocols, non-human subjects research applications, data use agreements, sponsor enrollment and data safety reports, clinicaltrials.

gov submissions and maintenance.

• Work closely with and assist principal investigators in planning, execution and follow-up for all aspects of clinical and human subjects research.
• Responsible for participant remuneration and transportation, including management of the Amazon and Uber Business accounts.
• Manage the clinical research email account and Crimson Fax portal.
• Liaise between faculty, principal investigators, federal sponsors (e.g., DARPA, NIH, NSF, DOD), University stakeholders (e.

g., IRB, Computing, Vice Provost for Research, Research Compliance, Office of Technology Development, research monitors) and the sponsored research team to assist with grant and conflict of interest reporting requirements.

• Facilitate relevant agreements (e.g., equipment loan agreements, CDAs, Risk and Release).
• Manage federally funded multi-site clinical trials.
• Maintain appropriate research records and documentation (i.e., manage the regulatory and participant binders).
• Participate in writing clinical and human subjects research aspects of research proposals, reports, presentations, and publications.
• Demonstrate a commitment to diversity, inclusion, and cultural awareness through actions, interactions, and communications with others.
• Manage, train, participate, and oversee researchers’ study coordination program, ensuring safety and compliance in the research lab’s performance of aspects of study participant recruitment, screening, enrollment, and follow-up.
• During first year, manage the transition of IRB protocols from the Wyss Institute’s Clinical Research Team to the SEAS Clinical Research Team.

Additionally you may, as needed :

• Coordinate study participant recruitment, screening, enrollment and follow-up.
• Assist with data entry into appropriate databases.
• Coordinate the sharing of data with collaborators.
• Periodically monitor study material and regulatory documents.

This position will work closely with the Wyss clinical research team for an initial period of time.