Clinical Research Coordinator

at  Harvard University

JOB SUMMARY

The Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) seeks 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. As a Clinical Research Coordinator, you will be part of a team that provides administrative support for in-person clinical and human subjects research studies. SEAS clinical research focuses on engineering: adaptive technology, wearables, motion, and motion capture. Our clinical research ranges from fully novel innovation to more established clinical trials, requiring creativity and compliance deftness.¿Our populations range from healthy to medical participants serving diverse community interests.¿To learn more about the cutting-edge research happening at SEAS, please visit¿seas.harvard.edu.

POSITION DESCRIPTION

• Prepare and submit documents to Institutional Review Boards (IRBs)
• Coordinate study participant recruitment, screening, enrollment and follow-up
• Train and collaborate with researchers to perform aspects of study participant recruitment, screening, enrollment, and follow-up
• Work with researchers and the SEAS Motion Capture Lab team and participate in study preparation and visits as appropriate to ensure study visit compliance and appropriate study staffing
• Engage with the SEAS clinical research team and faculty in developing best practices and protocol restructuring proactively
• Develop SEAS specific clinical research and IRB procedures in collaboration with SEAS Science Operations to support IRB research at our numerous research sites
• Prepare testing materials and/or lab space for scheduled visits
• Maintain appropriate research records and documentation Manage and coordinate team efforts and assigned studies
• Periodically monitor study material and regulatory documents
• Demonstrate a commitment to diversity, inclusion, and cultural awareness through actions, interactions, and communications with others

This position will work closely with the Wyss clinical research team for an initial period of time. Additionally, you may, as needed:

• Assist Principal Investigators with study procedures, data management and analysis where appropriate
• Assist with data entry into appropriate databases
• Coordinate the sharing of data with collaborators
• Participate in writing research proposals, reports, presentations, and publications
• Support staff, faculty, and collaborators to generate critical data, figures or summary information

BASIC QUALIFICATIONS

A minimum of one year of study coordination, clinical research or related work experience.

ADDITIONAL QUALIFICATIONS AND SKILLS

• College background or equivalent work experience, preferably in the health sciences or related discipline. Bachelor’s degree preferred.
• Two or more years of study coordinator or clinical research coordinator experience is strongly preferred.
• 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.)
• Experience with data entry
• Experience with participant recruitment
• Experience with clinical studies involving medical devices, biologics, or drugs is preferred
• Excellent organizational skills, attention to detail, creativity, and effective communication (oral and written) abilities
• Proficient with office productivity software (MS Word, Excel, PowerPoint, etc.)
• 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
• Ability to work with study participants, caregivers, and staff in a clinical/research setting. IACUC and COMS (institutional biosafety committee) experience are also preferred but not required

ABOUT US

The Harvard John A. Paulson School of Engineering and Applied Sciences serves as the connector and integrator of Harvard’s teaching and research efforts in engineering, applied sciences, and technology. Our core tenets are educating broad-minded students; interdisciplinary research; integration across disciplines; and balancing theory, experimentation, and practice to create an unmatched environment for learning and exploration. Through collaboration with researchers from all parts of Harvard, other universities, and industry, we bring discovery and innovation directly to bear on improving human life and society. For more information about us, please visit www.seas.harvard.edu.

Please refer the Job description for details