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
Responsibilities
- Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”
- During your employment with HRI 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
Education & Experience :
Bachelor’s Degree- Required
Degree – Preferred
1+ years of relevant experience – Required
Licenses, Certifications, & Training :
Certified Clinical Research Coordinator
Knowledge :
Knowledge of organizational policies, standard operating procedures, and systems
Emerging understanding and application of ICH guidelines and the Code of Federal Regulations within the clinical research environment.
Basic understanding of medical terminology
