CCRA (Certified Clinical Research Associate), CCRC (Certified Clinical Research Coordinator), CCRP (Certified Clinical Research Professional)
Academic / Research
2 Year Degree
The Research Study Coordinator oversees and coordinates the daily activity of clinical research studies. They work closely with the clinical teams and investigators to ensure that all protocol required procedures and visits occur according to protocol specific guidelines.
Responsible for organizing all aspects of the clinical trials assigned.
Participate in investigator meetings, site initiation meetings, etc. as needed.
Manage participant enrollment and ensure compliance with protocol and all applicable regulations.
Responsible for Participant Recruitment and screening of potential subjects according to protocol ensuring eligibility criteria are met.
Conduct informed consent process.
Conduct study related visits.
Monitor subjects per protocol requirements.
Assess, monitor and report adverse events per protocol.
Maintain required records of study activity including source documentation, case report forms, drug dispensation records, and data management system entry.
Dispenses medical devices or drugs, calculate dosages and provides instruction.
Complete case report forms and resolve queries.
Report all protocol deviations to PI, sponsor and IRB as required.
Obtain, process and ship study related specimens.
Provide assistance to fellow study coordinators.
Manages quality assurance activities for assigned protocols per site SOP’s.
Ensures adherence to study protocols and study quality, maintains subject confidentiality.
Submits regulatory documents to IRB and Sponsor, including initial site submission, continuing review, final report, reportable protocol deviations, and reportable SAE’s.
Prepare study for initiation.
Ensures and documents protocol amendment training for all study staff, as needed.
All other related duties as assigned.
Must have or obtain SoCRA, ACRP or other reputable certification.
Demonstrated leadership experience. Must be able to demonstrate leadership by serving as an example to others with regard to professional behavior, handling multiple tasks, maintaining a positive attitude, and in response to organizational change.
Proficiency with Microsoft Word, Excel and Powerpoint.
Must possess excellent leadership, organizational, computer, and communication skills.
Ability to work effectively and cooperatively with staff, board, clients, and the public.
Ability to multi-task, prioritize appropriately, and work well both individually and as part of a team.
Ability to use time productively and contribute to high levels of company operational efficiency and effectiveness.
Additional Salary Information: Salary will be based on level of education completed and experience.
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