Clinical Research Coordinator
Department Information
The Indiana Alzheimer's Disease Research Center (IADRC) and the Center for Neuroimaging (CFN), housed within the Department of Radiology and Imaging Sciences at Indiana University (IU) School of Medicine, support nationally recognized clinical research programs focused on Alzheimer's disease and related dementias, neurodegenerative disease, brain health, and advanced neuroimaging.
The IADRC is a National Institutes of Health (NIH)-funded Alzheimer's Disease Research Center dedicated to advancing early detection, diagnosis, treatment, and prevention of Alzheimer's disease and related dementias through interdisciplinary clinical research, neuroimaging, biospecimen collection, data sharing, outreach, and participant-centered engagement.
The Center for Neuroimaging provides infrastructure and operational support for a broad portfolio of imaging-intensive clinical research studies, including MRI, PET, cognitive assessment, biomarker collection, and multi-site research collaborations.
Job Summary
The Clinical Research Coordinator will support clinical research activities across the IADRC Clinical Core, IADRC Neuroimaging Core, and affiliated CFN studies. This position will coordinate and conduct participant-facing research activities involving older adults and individuals with cognitive concerns, Alzheimer's disease, related dementias, and other neurodegenerative conditions. This role will support recruitment, screening, scheduling, consenting, study visit coordination, clinical and behavioral assessments, neuroimaging workflows, biospecimen-related activities, data entry, regulatory documentation, and participant follow-up.
Department-Specific Responsibilities
- Coordinates participant-facing clinical research activities across the IADRC Clinical Core, Neuroimaging Core, CFN studies, and affiliated protocols.
- Supports recruitment, screening, scheduling, consenting, visit preparation, follow-up, and retention.
- Communicates with participants, study partners, caregivers, clinicians, imaging staff, and research team members.
- Coordinates complex visits involving cognitive testing, clinical assessments, MRI, PET, blood draw, lumbar puncture, biospecimen collection, and return-of-results workflows.
- Prepares participant materials, study documents, imaging orders, source documents, and correspondence.
- Collects, enters, reviews, and maintains study data and documentation.
- Supports participant reimbursement, parking validation, supplies, study materials, and cross-coverage needs.
- Conducts clinical research studies in accordance with approved protocols, institutional policies, Good Clinical Practice, and regulatory requirements.
- Screens, consents, enrolls, and follows participants according to protocol.
- Coordinates study visits, tests, assessments, imaging visits, procedures, and follow-up activities.
- Conducts interviews, questionnaires, assessments, and other protocol-specific research activities.
- Communicates with participants, healthcare providers, laboratory personnel, and study team members.
- Monitors enrollment, retention, visit completion, study timelines, and protocol compliance.
- Documents and escalates adverse events, protocol deviations, participant concerns, and operational issues.
- Performs related duties and cross-coverage assignments as needed.
General Responsibilities
- Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
- Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects.
- Facilitates and performs various study activities including site evaluation visits, study related meetings and training sessions, study initiation visits (SIV) and monitoring visits.
- Manages all follow-up activities with subjects based on protocols and oversees proper documentation at study close-out.
- Participates in study budget negotiations and reconciles study budget accounts.
- Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
- Ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
- Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
- Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
- Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
- Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
- Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
- Stays up to date with knowledge of regulatory affairs and/or issues.
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