What are the responsibilities and job description for the Clinical Research Coordinator position at System One Holdings, LLC?
Title : Clinical Research Coordinator
Location : Asheville, NC
Type / Duration : Contract, 6 months, highly renewable
Schedule : Monday-Friday, core daytime business hours based on clinic
Start Date : Target is Jan 27, 2025
Summary of Key Responsibilities
Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and monitoring while the subjects are on study. Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports.
Duties and Responsibilities :
Duties include but are not limited to :
- Supports enrolling patients onto the clinical trial through screening, enrollment and follow up of eligible subjects according to protocol requirements
- Ensures the protection of study patients by verifying informed consent procedures and adheres to protocol requirements / compliance
- Collects, completes, and enters data into study specific case report forms or electronic data capture systems
- Ensures timely and accurate data completion
- Collects blood samples and tracks shipments and requests supplies as needed (must have blood draw experience)
- Implements study-specific communications
- Ensures timely adherence to protocol requirements
- Responsible for completion of all required documentation
- Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, subject logs and study-related communications
- Communicates all study-related issues to appropriate study colleagues or manager
- Apprises principal investigator and management of all study specific medical issues for guidance
- Attends study specific meetings as required or asked to do so
- Reviews and responds to any monitoring findings and escalates issues
- Organizational and prioritizing capabilities
- Computer skills with demonstrated abilities using web-based applications, electronic data capture, and MS Word or Excel
- Professional communication
- Communicate and work effectively with a diverse team of professional
- Interpersonal skills, detail-oriented and meticulous
- Work independently in a fast pace environment with minimal supervision at off-site facilities
