Clinical Research Coordinator I
Under moderate supervision, coordinates all clinical research activities within the scope of clinical research protocols.
Job Responsibilities
Core responsibilities
- Adhere to an IRB approved protocol
- Participate in the informed consent process of study subjects
- Support the safety of clinical research patients/research participants
- Coordinate protocol related research procedures, study visits, and follow-up care
- Screen, recruit and enroll patients/research participants
- Maintain study source documents
- Report adverse events
- Understand good clinical practice (GCP) and regulatory compliance
- Educate subjects and family on protocol, study intervention, etc.
- Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
- Must comply with federal, state, and sponsor policies
Related responsibilities
- Manage essential regulatory documents
- Register study on ClinicalTrial.gov
- Complete case report forms (paper & electronic data capture) and address queries
- Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
- Facilitate pre-study, site qualification, study initiation, and monitoring visit
- Facilitate study close out activities
- Coordinate research/project team meetings
- Collect, process and ship laboratory specimens
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
Job Responsibilities (Continued)
Job Responsibilities (Continued)
Required Licenses, Certifications, Registrations
Required Education and Experience
Required Education:
- Associates Degree or active enrollment in a Bachelor’s Degree Program
Required Experience:
- Three (3) years of coordination related, clinical related or research related experience.
Preferred Education, Experience & Cert/Lic
Preferred Education: Bachelor’s Degree in related field
Additional Technical Requirements
- Excellent verbal and written communications skills
- Excellent time management skills
- Ability to collaborate with stakeholders at all levels