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The Clinical Research Coordinator I will work with an interdisciplinary team of neurologists, neuropsychologists, and clinical researchers with expertise in Alzheimer’s disease and related dementias.
The incumbent will be responsible for overseeing studies related to the Memory Disorders Program including establishing a longitudinal clinical cohort and maintaining a clinical research registry.
The CRC member will be responsible for conducting phone screenings, coordinating visits, obtaining informed consent, conducting clinical research procedures, and assisting with regulatory responsibilities.
The CRC will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
This is a hybrid position
Primary Duties and Responsibilities :
- Scheduling research visits and procedures for research participants.
- In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following - changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
- Maintains accurate source documents related to all research procedures.
- Schedules and participates in monitoring and auditing activities.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Independently works with external study monitors and / or auditors.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May involve other regulatory / IRB duties, budgeting duties, and assisting with research participant billing and reconciliation.
- May supervise Clinical Research Associates on data entry, data query, and resolution.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
Education :
- High School Diploma / GED is required.
- Bachelor degree in Science, Sociology or related degree is strongly preferred.
Licenses / Certifications :
ACRP / SoCRA (or equivalent) certification is preferred.
Experience :
- One year of clinical research or coordinating clinical research trials experience is required.
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