Clinical Research Coordinator (Gastroenterology)
- Cincinnati, OH
What you'll be doing
- This position is responsible to assist in coordinating studies by preparing personnel and materials, preparation of protocols, informed consents, amendments and other necessary documents for review by the IRB and sponsor. Assemble lab kits and gather supplies. Collect and label samples as instructed and deliver or process samples in accordance with the protocol, a manual of operations, SOP or other work instruction set. Identify regulatory activities to be completed and takes the initiative to complete; coordinate and participate in the assembly of materials. Assist with maintaining protocol specific SOPs, IRB, and regulatory correspondence. Demonstrate an awareness of federal regulations; state and local law; GCP or ICH and company policies to promote ethical practices in research involving human participants and to ensure compliance to those regulations. Assist with the documentation of regulatory activities and maintenance of the regulatory binder in keeping with the institution and division SOPS. Maintain awareness of the status of all active studies; identify potentially eligible participants; coordinate, plan and execute study visits and provide instructions and reimbursement to participants. Execute the informed consent process according to GCP, company procedures, and other applicable policies. Assist with organizing and filing all correspondence; refer questions and issues that arise during study conduct to the appropriate research team member. Complete CRFS and source documentation in compliance with all applicable guidelines for human research. Review CRFS to ensure completeness, accuracy and compliance with GCP. Enter data into various auditable databases or electronic data capture systems. Coordinate training activities and assembles training materials in preparation and conduct of clinical trials. Assist in developing and delivering guidelines and educational materials for investigators, research support staff and the clinical team.
What your background should be
- Two to four years related experience in research or a related field. Knowledge of scientific terminology; computer proficiency and working knowledge of basic computer applications are preferred. Strong and excellent communication skills in verbal and written; interpersonal and organization skills are preferred.
Required Schooling / Training
- High school graduate required and bachelor degree or associate degree preferred.
Who is the client company
- This is a hospital and health care company.
- If you are interested in this position, send your resume to email@example.com