Description
The West Virginia Clinical & Translational Science Institute (WVCTSI) at West Virginia University is currently accepting applications for a Temporary Clinical Research Coordinator Certificate Trainee.
About the Opportunity
As a Clinical Research Coordinator Certificate Trainee, you will be enrolled in the IDeA State Consortium for Clinical Research - Resource Center (ISOCRE-RC) Clinical Research Coordinator Development Program (CRCDP). Under the supervision of a preceptor, the trainee will complete 400 hours of experiential training and approximately 60 hours of self-paced didactic learning. This program is designed to provide trainees with the basic skills and knowledge to begin a career as a clinical research coordinator or specialist. The goal of the program is to build workforce capacity for clinical trials research. Under direct supervisions, trainees will participate in the development, coordination, and implementation of research and administrative strategies essential to the successful management of Phase II/III/IV clinical trials research conducted by faculty at West Virginia University Health Sciences Center. Performs a variety of duties involved in clinical trial coordination and implementation, organization, oversight, documentation, tracking, data abstraction and collection and compilation of clinical research data.
Pay Grade: 15
Assignment Length: Approximately 8 months
Work Hours: 12 hours per week (FTE 0.32)
What you'll do:
I. Protocol Compliance: Facilitates compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of the needs of diverse patient populations.
Identifies the requirements of various types and phases of clinical trials, including objectives, sample sizes, and patient care needs.
Identifies sources for and facilitates adherence to current regulations, guidance, and policies that affect research at the institutional, state, federal, and international levels.
Promotes compliance with the varied processes and procedures required by different types of sponsors (e.g., private industry, National Institute of Health, investigator-initiated).
Protects patient, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
Observes discussions regarding feasibility of protocol implementation based on institutional capabilities and limitations, therapy, or population of interest.
Complies with the International Air Transport Association and institutional policies for shipping and receiving biological specimens, experimental agents, and devices.
Collaborates with the research team to implement procedures for maintaining patient study participation from enrollment through completion.
Identifies the institutional review board (IRB) of record (local, central, or commercial), protocol-related policies of the IRB, and preferred contact method.
Participates in providing timely, informative, and accurate communication to the IRB as required.
Observes scheduled and unscheduled meetings with external and internal monitors and auditors, including but not limited to the U.S. Food and Drug Administration (FDA), Medicare reviewers, the IRB, and quality assurance.
Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events.
Collaborates... For full info follow application link.
West Virginia University is proud to be an Equal Opportunity employer and is the recipient of an NSF ADVANCE award for gender equity. The University values diversity among its faculty, staff, and students, and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.