Clinical Research Manager | Harvard University John A. Paulson School of Engineering and Applied Sciences - Military Veterans

Job Summary Through teaching and collaborative research, the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) discovers, designs, and creates novel technologies and approaches to societal challenges in service to the world, the nation, and our community. We bridge disciplines, both within engineering and the applied sciences and beyond, to prepare broadly trained leaders, to advance foundational science, and to achieve translational impact. You are a collaborative, impact-focused problem solver who wants to be part of a dynamic organization dedicated to creating and commercializing novel approaches to societal challenges. You want the opportunity to innovate and apply your knowledge to tackle projects in a fast past-paced, entrepreneurial environment. You enjoy working with and leading highly motivated, diverse teams and leveraging your expertise to create innovations that can change the world. Position Description 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. Basic Qualifications Bachelor's or advanced degree in physiology, public health, biology, engineering, or a related discipline. Three or more years of related experience which must include clinical research administration or clinical research, or a combination of both. Additional Qualifications and Skills Experience working with Institutional Review Boards for human clinical studies including protocol generation, continuing review, enrollment tracking, and completion of required forms (consent, adverse event, etc.). Prior experience managing people is preferred. Experience with participant recruitment and working with patients in a clinical setting, clinical research data entry, and multisite clinical studies. Experience with clinical studies involving medical devices, biologics, or drugs. Excellent organizational skills, attention to detail, creativity, and effective communication (oral and written). Ability to work on and track multiple projects and meet deadlines. Ability to handle confidential information with discretion. Willingness to work at all levels to accomplish team goals. Proficient with office productivity software (MS Word, Excel, PowerPoint, etc.). Certificates and Licenses Certified Clinical Research Professional (CCRP) certification preferred Additional Information The Harvard John A. Paulson School of Engineering and Applied Sciences does not provide visa sponsorship for administrative and staff positions. Applicants should submit a resume and cover letter. The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up-to-date on CDC-recommended vaccines. Benefits We invite you to visit Harvard's Total Rewards website (