Job Summary:
The Clinical Research Coordinator manages protocols to ensure the safety of patients, quality of clinical trial data and compliance with facility, system and Federal Research regulations through oversight of Institutional Review Board (IRB) paperwork, maintenance of all related regulatory document submissions and communication/coordination of study activities with the Primary Investigator and any Sub-Investigators of clinical studies.
Job schedule: Day shift; requires rotating on call.
Essential Functions:
Coordinates with Principal Investigator, Research Manager and other study personnel to ensure that clinical research and related activities are performed in accordance with ICH/GCP, federal regulations, sponsoring agency requirements, Atrium Health Navicent Medical Center policy and procedures and each study protocol.
Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Collects regulatory and other documents needed to initiate the study and submit to the sponsor.
Assists PI in communication of study requirements to all individuals involved in the study. Participates in appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study.
Completes study documentation and maintains study files in accordance with sponsor requirements and hospital policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Maintains adequate inventory of study supplies.
Ensures each study participant is documented correctly in the billing system to ensure billing of study procedures to the appropriate funding source.
Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Education, Experience and Training:
Bachelor's degree. Healthcare related preferred.
Three (3) years Research and Data Management experience.
Working knowledge of Microsoft Office Suite and a wide variety of software applications.
Proficiency in the review and abstraction of clinical patient information from a medical record.
Mathematical ability necessary to validate and analyze data.
Certification in clinical research (SoCRA, ACRP) preferred.
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