Clinical Research Coordinator II
2 weeks ago
POSITION SUMMARY:
The Clinical Research Coordinator Level II is responsible for executing and managing daily clinical research operations in accordance with Good Clinical Practice (GCP) and FDA/ICH standards. This role involves the preparation and organization of all Institutional Review Board (IRB) and Sponsor regulatory documentation, ensuring adherence to approved protocols, and conducting training for study-specific protocols. The coordinator plays a vital role in educating patients and their families about clinical trial options, determining patient eligibility for studies, and overseeing the informed consent process. Additionally, this position monitors patient safety and status, coordinates visits as per protocol, and manages lab sample collection, processing, and shipping. The coordinator is also tasked with collecting, organizing, and reporting research data while addressing any queries that arise. Inventory management of investigational products and oversight of their dispensing are essential duties, along with invoicing for study-related activities. The coordinator actively participates in monitoring visits with study sponsors and regulatory bodies, providing regular updates to the Principal Investigator and Director of Clinical Research.
This role is classified as a Safety Sensitive Position.
The essential functions, physical demands, and mental competencies of this position require the employee to maintain a constant state of alertness to ensure safety.
SPECIFIC DUTIES AND
RESPONSIBILITIES:
1.
Under the direct supervision of a physician, the coordinator is responsible for recruiting, maintaining, and ensuring protocol compliance for all participants in clinical trials.
2. Collaborates with the physician to assess patient eligibility for clinical trials.3.
Ensures the quality of site research by adhering to Standard Operating Procedures (SOP), GCP principles, and relevant federal, state, and local regulations.
4. Screens potential participants for eligibility, presents trial information, facilitates the informed consent process, and enrolls patients in the study.5. Coordinates patient care in line with protocol requirements, which may include dispensing investigational drugs and providing patient education on administration. Maintains accountability for investigational drugs.
6.
In collaboration with the physician, monitors patients for changes in condition, adverse events, concomitant medication use, protocol adherence, and responses to study drugs, documenting all findings thoroughly.
7. Responsible for precise and timely data collection, documentation, entry, query resolution, and reporting. Schedules and participates in monitoring and auditing activities.8. Maintains regulatory documentation in compliance with SOPs and applicable regulations.
9. Engages in required training and educational programs, and is responsible for educating clinic staff about clinical research.
10.
Ensures a safe environment for patients, families, and clinical staff at all times by complying with all federal, state, and professional regulatory standards as mandated by OSHA and the CDC.
11. Interacts with Clinical Trial Sponsors to identify new clinical trials for the site, and collaborates with the Principal Investigator to conduct feasibility assessments and participate in site selection processes.12. Maintains documentation of clinical trial visits and invoices for completed site activities.
13. Orders and manages inventory of all study-specific supplies, including recruitment materials and laboratory kits.
14. Collects, processes, and ships all study-defined laboratory kits to the designated Central Lab as directed by the sponsor.
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