Coordinator 4, Research Support

Overview

The Coordinator 4, Research Support, plays a pivotal role in ensuring the regulatory compliance, operational execution, and successful coordination of complex clinical research studies within the YSM Rheumatology Department, including the Yale Scleroderma Program. Reporting to the Program Manager, this position oversees the full lifecycle of multiple concurrent clinical trials, including study start-up, regulatory submissions, participant coordination, sponsor communication, electronic data capture (EDC) oversight, and ongoing compliance with IRB, federal regulations, and Yale policies.

This role serves as a central operational and regulatory liaison between investigators, research staff, sponsors, regulatory bodies, and institutional offices to ensure studies progress on schedule and in compliance with protocol requirements. The Coordinator supports complex schedules of activities, aligns clinical workflows with protocol timelines, and ensures documentation and reporting standards are met across multiple studies.

In addition, this role provides high-level coordination of specimen workflows and oversight of biorepository-related activities, including specimen collection processes, documentation, freezer organization, and long-term storage tracking to support translational research. The Coordinator works across multiple sponsored and investigator-initiated trials simultaneously, requiring advanced organizational skills, regulatory expertise, and the ability to manage competing priorities while maintaining data integrity and subject safety.

Required Skills and Abilities

1. Proven ability to independently manage complex clinical research operations, including study start-up, ongoing trial coordination and close-out, in compliance with IRB, sponsor, and federal regulatory requirements.
2. Strong written and verbal communication skills with demonstrated ability to coordinate across investigators, research staff, sponsors, regulatory bodies, and institutional offices.
3. Advanced organizational and time-management skills with the ability to manage multiple concurrent trials, regulatory timelines, and competing deadlines.
4. High proficiency with EDC systems and clinical research platforms, including Epic, REDCap, and sponsor-specific EDC systems, with responsibility for data quality, query resolution, and audit readiness.
5. Demonstrated ability to coordinate clinical workflows and schedules of activities, including visit windows, protocol-required procedures, and cross-team scheduling.

Preferred Skills and Abilities

1. Bachelor’s degree in a health or research-related discipline with three or more years of experience coordinating complex clinical research studies, including industry-sponsored clinical trials.
2. Demonstrated experience with IRB submissions, sponsor regulatory requirements, protocol amendments, and audit preparation.
3. Advanced data management experience, including REDCap build/maintenance, sponsor EDC platforms, data cleaning, and support for manuscript and abstract preparation.
4. Proven experience with biospecimen workflows and biorepository oversight, including specimen tracking, chain-of-custody documentation, and coordination with laboratory personnel.
5. Prior experience in rheumatology, autoimmune disease research, or longitudinal clinical research programs.

Principal Responsibilities

1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols.
2. Documents established congruency between funding proposals and approved protocols.
3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols.
4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner.
5. Attends meetings and presents issues when necessary that were identified during congruency review.
6. Serves as a resource and provides technical assistance to investigators and their staff.
7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed.
8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements.
9. Develops, implements, and manages internal practices that ensure compliance with federal requirements.
10. May perform other duties as assigned.

Required Education and Experience

Bachelor’s degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience.