Clinical Research Coordinator at Indiana University in Indianapolis, Indiana

Job TitleDepartment RADIOLOGY & IMAGING SCIENCES (IN-RADY-IUINA) Job Summary Department-Specific ResponsibilitiesCoordinates and conducts participant-facing research activities involving older adults and individuals with cognitive concerns, Alzheimer's disease, related dementias, and other neurodegenerative conditions.Coordinates and supports participant-facing clinical research activities across the Indiana Alzheimer's Disease Research Center (IADRC) Clinical Core, Neuroimaging Core, CFN studies, and affiliated protocols.Supports recruitment, screening, scheduling, consenting, visit preparation, clinical and behavioral assessments, neuroimaging workflows, biospecimen-related activities, data entry, regulatory documentation, 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 ResponsibilitiesInitiates 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.Qualifications Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.RequiredBachelor's degree in science or a health-related field plus 1 year of clinical research experience; ORAssociate's degree in science or a health-related field plus 2 years of clinical research experience.PreferredSOCRA/ACRP Clinical Research Certification upon date of hire.RequiredDemonstrates analytical skills.Ability to simultaneously handle multiple priorities.Possesses strong technical aptitude.Demonstrates a high commitment to quality.Excellent organizational skills.Working Conditions / Demands The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.Additional Information This position is not eligible for visa sponsorship. Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including:Comprehensive medical and dental insuranceHealth savings account with generous IU contributionsHealthcare and dependent care flexible spending accountsBasic group life insurance paid by IUVoluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insuranceBase retirement plan with generous IU contributions, subject to vestingVoluntary supplemental retirement plan optionsTuition subsidy for employees and family members taking IU courses10 paid holidays plus a paid winter break each yearGenerous paid time off plansPaid leave for new parents and IU-sponsored volunteer eventsEmployee assistance program (EAP)Learn more about our benefits by reviewing the IU Benefit Programs Brochure.