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| Name | Clinical Research Coordinator | Roles & Responsibilities | YohYoh Media Square | Clinnovo |
| Video Uploader | Video From YohYoh Media Square |
| Upload Date | This Video Uploaded At 23-05-2019 09:33:19 |
| Video Discription | Clinnovo.com offers Services & Training in Clinical Research and Clinical Data Management Contact: contact@clinnovo.com +91 99128 68928 Clinical Research Coordinator Responsibilities The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator. CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. CRC coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors. Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs. CRC attends investigator meetings as required or requested by the PI. Collaborates with the PI to prepare IRB and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation. 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. Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals. Conducts or participates in the informed consent process including interactions with the IRB, discussions with research participants, including answering any questions related to the protocol. 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. 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 Assists PI in preparation and submission of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures. Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others to the IRB l7_87S8E4-8 |
| Category | Education |
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