The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Research Manager and research team. The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the overall conduct of the study.
Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Assists the regulatory team in collecting documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
Conducts or participates in the informed consent process with research participants including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
In collaboration with the research team, screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
Communicates with billing department to ensure billing of study procedures to the appropriate funding source.
Coordinates the scheduling and ordering of protocol related tests and procedures.
Collects data as required by the protocol. Assures timely completion of Case Report Forms.
Maintains adequate inventory of study supplies.
Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, and case report forms.
Retains all study records in accordance with sponsor requirements and University policies.
Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
Assists PI and the regulatory team in the preparation of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.
Works with the PI and Clinical Research Manager to manage the day to day activities of the study including problem solving, communication and protocol management.
Collects, processes and ships biological specimens as indicated by the protocol
Bachelors degree required. A minimum of 2 years experience in clinical research, and must include working a least 1 year experience as a Clinical Research Coordinator on industry sponsored studies.
Additional Salary Information: Based on experience
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