POSITION: Clinical Research Coordinator
INDUSTRY: Health Care – Retina/Ophthalmology Specialty
We are looking to hire a Full time Experienced Clinical Research Coordinator who is familiar and has working knowledge of all aspects of Clinical trial research for our Augusta GA office location
Essential Duties and Responsibilities:
• Coordinate all clinical trial activities and play a key role in the conduct of the study.
• Schedule study participant's appointments and serves 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 visit, 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, 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 log.
• 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 specimen.
• Assist with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and 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
Desired skills and experience:
The ideal candidate must have a minimum of >3 years’ experience in Clinical research. Professionalism, Excellent organizational skills, ability to work independently and in a team is essential for this position. A bachelor’s degree in Health sciences, experience in ophthalmology/ optometry/retina research/practice, or Certification in Clinical Research is a definite plus but not required
This job is located in Augusta, GA.