About the job
Company Description The Institute for Neurodegenerative Disorders (IND) is an independent 501(c)(3) nonprofit research institute based in New Haven, Connecticut, founded in 2000. IND’s multidisciplinary team includes neurologists, nurses, study coordinators, neuropsychologists, and nuclear medicine technologists collaborating to advance clinical research. The organization is dedicated to developing diagnostic tools and new treatments for patients with neurodegenerative conditions. IND envisions a future where research enables early detection, effective treatment, and prevention of neurologic diseases, with clinical research at the core of this mission. Candidates will join a purpose-driven environment focused on meaningful impact for patients and families.
Role Description: Clinical Research Coordinator II (CRC II) independently manages moderately complex clinical research studies in accordance with study protocols, regulatory requirements, and internal SOPs. Responsibilities include participant management, study visits, informed consent, data collection, documentation, protocol implementation, and regulatory compliance. The CRC II collaborates with multidisciplinary teams, supports sponsor and regulatory interactions, provides mentorship to junior staff, and provides cross-coverage support as needed, consistent with training and clinic needs.
Essential Job Functions & Responsibilities
- Independently manage low to moderately complex clinical research studies, serving as lead coordinator and primary contact for assigned participants while ensuring protocol adherence, regulatory compliance, and high-quality study conduct.
- Conduct and oversee participant visits, including screening activities, informed consent processes, neuropsychological assessments, collection of protocol-required clinical data (e.g., medical history, medications, vital signs, ECGs), participant follow-up, and procedural support consistent with training and delegated responsibilities.
- Maintain accurate study documentation, including source documentation, data entry, query resolution, and timely completion of study records to support data quality, audit readiness, and protocol compliance.
- Identify, document, and manage protocol deviations, participant safety concerns, adverse events, and noncompliance issues, escalating as appropriate and collaborating with regulatory personnel and clinic leadership to support resolution.
- Support study start-up, sponsor interactions, monitoring visits, and regulatory activities, contributing to problem-solving, study execution, operational improvement initiatives, and ongoing protocol compliance.
- Support participant recruitment, retention, and scheduling efforts, including contributing to recruitment strategies, participant outreach, and visit coordination to support enrollment goals and participant experience.
- Provide mentorship, training, and operational guidance to CRC I staff and study support personnel, reinforcing Good Clinical Practice (GCP), protocol adherence, and development of clinical research competencies.
- Provide cross-coverage support as needed for clinical and operational activities outside primary study coordination responsibilities, consistent with training, competency, and clinic needs.
- Collaborate effectively with multidisciplinary teams and contribute to continuous improvement initiatives, while performing additional duties as assigned by supervisor or clinic leadership.