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