Clinical Research & Data Coordinator
About The Jackson Laboratory for Genomic Medicine: Comprising 183,000 square feet of highly advanced, state-of-the-art laboratories and supporting facilities, JAX-GM is conveniently located midway between NYC and Boston in the heart of Connecticut's growing bioscience industry. Our mission at JAX-GM is to discover the complex causes of disease, develop diagnostics and therapeutics, and ultimately empower the global medical community.
JAX-GM is part of an exciting, internationally-recognized research and educational institution with unparalleled genomic resources and research support services. Seeking to advance personalized medicine, we draw on the institution's distinguished history and on the innovative expertise of our growing faculty, who are recruited from among the world’s top scientific labs and institutions.
About the position: The CRDC will assist in the coordination and administration of daily clinical research activities predominately for external clinical collaborations and will ensure that study protocols and regulatory documents are obtained and logged for each project. This position will be involved in the recruitment and coordination of research subjects for internal clinical studies and will serve as a primary contact for assigned projects. This role will assist in managing new IRB study submissions, modifications, and closures. The CRDC will maintain recordkeeping systems, schedules and appointments and will be involved in database and Case Report Form development, data collection, entry and maintenance.
The CRDC will cross train with the Clinical Research and Regulatory Coordinator role to provide clinical research support services for JAX investigators, as requested.
- Request and obtain regulatory documents, including informed consent forms, protocols and IRB approval letters, from external collaborators to ensure that all human tissues being studied at JAX have appropriate consent and regulatory approvals and that approval is maintained through the course of the study.
- Ensure compliance with regulations and internal and external policies governing data management and data systems, including good clinical practice (GCP), Food and Drug Administration (FDA), and JAX IT Security standard operating procedures (SOPs).
- Prepare IRB submissions for assigned studies using the IRBManager e-submissions system once implemented and via pdf forms in the interim; Assist investigators in successfully navigating the system, once implemented.
- Complete case report forms and maintain research records and source documentation per GCP guidelines; Accurately enter data into research databases and monitor data quality.
- Develop skill in RedCap electronic data capture and database management system and support JAX investigators and staff in adoption of RedCap EDC for data management.
- Minimum of two years of combined experience in clinical research, database development and management, RedCap, Medidata RAVE, or other EDC platform or an equivalent combination of education and experience; Current Human Subjects Protection training and Good Clinical Practices training is required.
- Excellent communication and organizational skills, including attention to detail.
- Ability to travel up to four times per year to JAX’s Bar Harbor facility to coordinate on-site clinical research for Bar Harbor investigators.
- Proficient in use of Microsoft Word, Excel, Outlook. Existing knowledge of RedCap or willingness to learn.
APPLICATION INSTRUCTIONS: Please include a cover letter along with your resume/CV. Applications without cover letters will not be considered.
MORE ABOUT JAX
JAX began in 1929 with a small group of scientists dedicated to the emerging field of genetics. We now have over 1,700 scientists, technicians, and support staff, including over 50 Principle Investigators in five primary disease areas: cancer, reproductive biology, immunology, metabolic processes and neuroscience. Our fundamental contributions to biomedical research include cancer genetics and establishing the mouse as the premier research animal model.
- Uncover more of our historic milestones, including the 26 Nobel prizes associated with our research, resources, and education
- Read our latest news & insights for a glimpse at how we’re impacting the future of biomedicine
- Follow the progress we’re making on our quest to improve human health via our recent research highlights
EEO: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.