Summary

The Department of Medicine is looking for a Senior Research Coordinator to assist with the management of multiple research projects. The candidate will oversee site operations for both multi-site and single-site studies, ensure protocol compliance, and work to ensure that project milestones are consistently met. The position requires excellent leadership skills, collaboration, and the ability to advance the section's research mission.

Coordinates day-to-day activities of research protocols, including screening, enrollment, and monitoring of research participants. Ensures accurate data collection, documentation, organization, and safety of research participants. Supervises, schedules, and directs the activities of less experienced research personnel.

Job Duties

• Oversees site operations for both multisite and single-site studies.
• Coordinates study activities and evaluates research quality at each site, including regulatory document control, protocol compliance, subject safety, data entry monitoring, and completion of reporting requirements.
• Assists in the development and maintenance of electronic data capture (EDC) systems by creating case report forms (CRFs) and conducting user acceptance testing (UAT).
• Manages the trial master file (TMF) for the study.
• Submits amendments in BRAIN and serves as the primary liaison to the local Institutional Review Board (IRB) for study submissions.
• Facilitates the movement of contracts, material transfer agreements (MTAs), and data transfer agreements (DTAs) through the pipeline; ensures accuracy of statements of work (SOWs) and other study-related information within contracts.
• Conducts site initiation visits and assesses site readiness for study start-up.
• Ensures the validity, completeness, and accuracy of clinical data collected by sites in collaboration with study PIs, statisticians, and technical teams; follows up with sites on missing or incorrect data.
• Develops protocol amendments, informed consent forms, manuals of operations, and data instruments for consortium amendment packages.
• Creates and maintains systems for processing and tracking regulatory documents, subject follow-up, outstanding queries, and related items.
• Prepares and submits annual progress reports for grant renewals.
• Tracks milestones and monitors progress of study deliverables.
• Manages consortium membership, meeting minutes, and communications.
• Supports study PIs with manuscript preparation by proofreading drafts, ensuring consistency, and collaborating with statisticians to obtain necessary data.
• Acts as a liaison between statisticians and clinical investigators; assists in preparing tables and figures for manuscripts, publications, and study reports.
• Approves patient compensation for local study sites.
• Generates reports for sponsor invoicing.
• Implements protocol changes to ensure study needs are met effectively.
• Orders research supplies.
• Cross-trains to support Regulatory RA across multiple studies.
• Archives IRB approvals and correspondence.
• Tracks and maintains updated training certificates, CVs, and professional licenses for individual team members.
• Processes forms to add or remove study team members.
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Master's degree in a scientific field.
• Five years of clinical research experience.
• Experience managing a variety of study types.
• Must possess strong interpersonal and communication skills, and demonstrate the ability to work effectively in a team environment.