Clinical Research Coordinator
- Attends investigator meetings as required or requested by the PI.
- Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.
- Coordinates with Principal Investigator, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures.
- 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.
- Collects documents needed to initiate the study and submit to the sponsor
- Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
- Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions 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.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
- Registers participants to the appropriate coordinating center (if multi-site study).
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.
- Completes study documentation and maintains study files in accordance with sponsor requirements
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management
- May require a BS, RN, or BSN degree or equivalent and 2-5 years of experience in the field or in a related area.
Thu, 6 Jul 2017 09:50:34 PDT