- Coordinate all clinical trial activities and play a key role in the conduct of the study.
- Schedule study participant's appointments and serve as the patient liaison to the PI and other participating physicians.
- Review and comprehend the protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
- Possess a thorough knowledge of the informed consent process
- Coordinate approval of new study agreements and contracts and develop clinical study budgets based on proposed study protocols
- Coordinate with sponsors pre-qualification visits, monitor visits, and study termination visits.
- Complete case report forms and respond to data clarification requests in a timely manner.
- Attend Investigator meetings that require travel and report pertinent information back to the research team.
- Coordinate with PI and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, and state and sponsoring agency's policies and procedures.
- Maintain logs and spreadsheets to track subject information such as subject screening logs and protocol deviation logs, delegation logs.
- Coordinate and facilitate monitoring and auditing visits.
- Collaborate with the PI and other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed.
- Perform specimen processing and shipment of biological specimens.
- Assist with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, drug/device accountability logs, and closeout documents
- Establish and organize study files, regulatory binders, study-specific source documentation, and other materials as required.
- Facilitate secure storage of study documents.
- Promote the ethical conduct of research
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Clinical Research Coordinator - Augusta, United States - Eye Health America
Description
ApplyJob Type
Full-time
Description
Southeast Retina Center, an affiliate of Eye Health America, is a growing, multi-specialty ophthalmology practice.? Our focus is on excellence in patient care and creating an exceptional customer/patient experience.
We are looking for an experienced Clinical Research Coordinator who is familiar with and has a working knowledge of all aspects of clinical research.
Job Duties:
