YCCI Clinical Trials Project Specialist

Yale University is a higher education and research institution. The YCCI Clinical Trials Project Specialist supports clinical research project management, regulatory documentation, Data and Safety Monitoring Board operations, study systems, compliance, and interdisciplinary project coordination.

What you'll do:

• Manages processing, tracking, and filing of study documentation and updates including adverse and serious adverse events, IND Safety Reports, Investigator Brochures, Package Inserts, Instructions for Use, and other essential study documents
• Collaborates with Investigators, study teams, and Project Managers to gather, review, and maintain essential regulatory documents within a Trial Master File (TMF)
• Coordinates Data and Safety Monitoring Board (DSMB) operations for assigned studies, including developing timelines for report preparation, coordinating data collection and review, facilitating DSMB meetings, ensuring timely submission of materials, documenting outcomes, and monitoring implementation of DSMB recommendations and action items
• Collates aggregate study data into reports for external audiences including Data and Safety Monitoring Boards (DSMBs), regulatory authorities, sponsors, and project funders
• Assists Project Managers in study oversight responsibilities and supports study management activities including drafting and revising study specific materials
• Manages study systems set up, access, and revisions, including Clinicaltrials.gov, CTMS (OnCore), Electronic Data Capture Systems (REDCap and Advarra EDC), and regulatory document systems (Advarra eReg)
• Assists in the identification, development, implementation of process improvements and operational solutions and assistance as needed under the supervision of senior team members
• Manages technology resources, including system requirements, user access, and system requirements for the assigned departments
• Provides administrative and project coordination support across multiple projects to ensure timely completion of deliverables
• Ensures compliance with University and federal regulations as they apply to the assigned departments
• Assists in reviewing, implementing and maintaining University and departmental policies and procedures related to the research operations and administrative functions of the department
• Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments

What they're looking for:

• Knowledge of ICH Good Clinical Practice (GCP) guidelines, and federal, state, and local guidelines pertaining to clinical research
• Flexibility in work focus; ability to switch among several different projects without any adverse effects
• Strong interpersonal skills to interact effectively and represent the school well with faculty, and study team members
• Excellent oral and written communication skills; very effective listening and feedback abilities
• Demonstrated organizational skills. Working knowledge of MS Office
• Bachelor's Degree in related field and two year of related experience or an equivalent combination of education and experience
• Bachelor's degree in related field or equivalent combination of education and experience
• Work experience in regulatory affairs, clinical trials coordination and/or management

Benefits:

• Remote work model