Clinical Research Coordinator

Position : Clinical Research Coordinator I

Client : Large Healthcare Organization

Location : Onsite - Asheville, NC

Duration : 1-year contract - possibility of FTE conversion

MUST RESIDE IN ASHEVILLE, NC OR NEARBY

Position Summary :

The Research Coordinator position is responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research.

Major Responsibilities :

• Oncology and Infectious Disease / Pediatric Oncology
• Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement"
• During your employment you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
• Performs routine operational activities for multiple research protocols
• Liaise between site research personnel, industry sponsors, and Supervisor
• Collaborates closely with various site departments / teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
• Coordinates schedule of assessments from initial submission of feasibility until study closeout
• Reviews the study design and inclusion / exclusion criteria with physician and patient
• Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements
• Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data
• Creates study specific tools for source documentation when not provided by sponsor
• Collects, completes, and enters data into study specific case report forms or electronic data capture systems
• Generates and tracks drug shipments, device shipments, and supplies as needed
• Ensures timely and accurate data completion
• Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations
• Communicates all protocol-related issues to appropriate study personnel or manager
• Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required
• Reviews and responds to any monitoring and auditing findings

Qualifications :