West Virginia University·West Virginia
The trainee will support the management of Phase II/III/IV clinical trials through protocol compliance, patient recruitment, and data collection. They will also facilitate the informed consent process and ensure adherence to regulatory and ethical standards.
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.
What You'll Do 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 with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for experimental devices or drugs as indicated.
Clinical Trials–Related Communication: Utilizes multiple communication methods to facilitate the effective conduct of clinical trials.
Participates in ongoing formal and informal communication regarding clinical trials with team members to include superb, frequent communication and periodic in-person meetings with the principal investigator to discuss the trial status, data and any relevant issue.
Provides general clinical research as well as trial-specific information to research, clinical, and other organizational staff.
Participates with preceptors in developing relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials.
Participates in study initiation meetings.
Provides education related to clinical trials to patients and their significant others.
Advocates for the safety and care of clinical trial patients as well as for the promotion and integrity of the clinical trial.
Informed Consent Process: Demonstrates leadership in ensuring patient comprehension and safety during initial and ongoing clinical trial informed consent discussions.
Ensures the initial and ongoing consent process is performed and documented in compliance with FDA, International Conference on Harmonization Good Clinical Practice (GCP), institutional, sponsor, IRB, and other applicable regulations, guidelines, and policies.
Participates in the education of clinical trial patients about their clinical trial and significant new information that is forthcoming during or after the conduct of the trial.
Assesses for barriers to effective informed consent discussions and implements plans to overcome them.
Management of Clinical Trial Patients: Involves a variety of resources and strategies to manage the care of patients participating in clinical trials, ensuring compliance with protocol procedures, assessments, and reporting requirements as well as management of symptoms.
Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol.
Assists with the adherence to the protocol schedule of events and other requirements.
Assists with the scheduling of all procedures required to assess for adverse events and disease response to the study intervention.
Assists with the successful completion of correlative components of the clinical trial (e.g., pharmacokinetic, pharmacoeconomic, and quality-of-life studies).
Assists with the assessment of patients for trial-related and non–trial-related symptoms and ensures evidence-based symptom management while maintaining trial compliance.
In collaboration with the investigator, assists with the assessment of patients for adverse events and then documents and reports these findings per the protocol and FDA, sponsor, and IRB policies.
Utilizes adverse event assessment data and clinical judgment to determine if a dose-limiting toxicity has occurred or if any treatment schedule or drug dose modifications are necessary and communicates findings to the study team and sponsors.
Reviews disease response results and physical assessment data in conjunction with the principal investigator and preceptor to determine response per the protocol.
Supports and evaluates patient adherence to the protocol by utilizing various methods to assist with documentation, patient education, and study agent return.
Identifies vulnerable patients who require increased nursing assessment and management in addition to the clinical trial requirements.
Bachelor's degree in relevant field. A minimum of 0-6 months of related experience. Any equivalent combination of related education and/or experience will be considered. All qualifications must be met by the time of employment.
Must possess and apply knowledge of many different and unrelated processes and methods related to such areas as: Treatment design, administration and modification. Counseling and education – principles and methods for training design, teaching and instruction for individuals and groups, and the measurement of training effects. Data collection, validation, entry, analysis, and reporting. Human subjects' protection and related issues – knowledge of professional principles (GCP and IRB guidelines), legal and/or reporting requirements affecting grants and contracts and adheres to industry and government standards. Skilled at being aware of others’ reactions and understanding why they react as they do. Skilled at communicating effectively in writing as appropriate for the needs of the audience. Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approached to problems. Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Position requires excellent customer service skills and the ability to communicate effectively with patients and families; pharmaceutical company personnel; regulatory and monitoring agency personnel; and internal staff members. Communicates with physicians, patients, students and employees of WVU, WVU Hospitals, MBRCC and UHA. Ability to develop constructive and cooperative working relationships with others and maintain them over time. Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations). Ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events). Ability to analyze information and evaluate results to choose the best solution, solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to develop specific goals and plans, to prioritize, organize and accomplish tasks independently and through others.
A bachelor's degree in a relevant field is required, with 0-6 months of related experience. Candidates must possess strong communication skills and knowledge of human subjects' protection and data validation.
Market context
In West Virginia, nursing and personal care aide roles are typically in steady demand because long-term care, home health, and assisted living settings rely on consistent direct-care staffing. These positions are competitive when candidates already hold CPR/First Aid, can safely lift and transfer residents, and show readiness for hands-on resident support. On this platform, the requirements and benefits are AI-summarized from the original job description, helping you review fit faster; if you plan to apply, confirm your aide training and certification details before submitting.
Administrative Assistant - Department of Pediatrics/Genetics
Pharmacist - Pharmaceutical Systems and Policy, School of Pharmacy
(Hybrid) Clinical Research Coordinator III- Clinical and Translational Science Institute