(Hybrid) Oncology Clinical Research Coordinator - Clinical Research Unit

West Virginia University•West Virginia, WV

1d•Hybrid

About The Position

The Clinical Research Coordinator III supports clinical trials (Phases I–IV) at the WVU Cancer Institute by coordinating research activities, ensuring protocol compliance, managing patient care, and maintaining data integrity. The role requires independent judgment, collaboration, and adherence to regulatory standards.

Requirements

Bachelor's degree from an allied health discipline, or related medical field (such as nursing, medical technology, pharmacy, etc.)
A minimum of two (2) years of working in a clinical setting and/or experience in clinical research.
Any equivalent combination of related education and/or experience will be considered.
All qualifications must be met by the time of employment.
Knowledge of clinical trials research.
Must possess and apply knowledge of many different and unrelated processes and methods related to such areas as: Patient care – information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
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.

Responsibilities

Ensure compliance with current regulations, guidance and policies at the institutional, state, federal, and international levels.
Assess feasibility of implementing new protocols.
Collaborate with investigators, research staff, pharmacy, clinical staff and other ancillary departments to implement and conduct trials.
Facilitate and participate in monitoring or auditing reviews conducted by internal and/or external agencies such as the U.S. Food and Drug Administration, industry, IRB and quality assurance.
Serve as a liaison between the research team, clinical staff, and sponsors.
Provide education to staff prior to implementation and throughout the lifecycle of the research study and monitor protocol adherence.
Support community outreach and trial advocacy.
Collaborate with research team utilizing internal and external resources to develop a recruitment strategy for each research study and evaluate effectiveness.
Ensure the initial and ongoing consent process is performed and documented in compliance with all applicable regulations, guidelines and policies.
Educate patients on trial participation, providing updates and information throughout the lifecycle of the study.
Assess for barriers to effective informed consent discussion and implement a plan to overcome as barriers are identified.
Assess eligibility and monitor patient adherence.
Ensure scheduling and adherence to all protocol tests and procedures.
Perform study assessments and/or procedures within the employee’s scope of practice which may include but not limited to vital signs, ECG, administering questionnaires, etc.
Assess and document adverse events in collaboration with the investigator.
Collaborate with investigator on dose modifications and treatment responses.
Advocate for ethical care of participants while adhering to the protocol requirements.
Maintain accurate source documentation and data reporting.
Provide protocol training to clinical staff and/or other members of the research team.
Ensure proper documentation practices from clinical staff and provide additional training, as needed.
Update the Clinical Trial Management System (CTMS) with protocol and patient information.
Review trial budgets and coverage analyses for adequacy of funding.
Distinguish between routine care and research-related expenses.
Ensure patients are reimbursed for research related expenses and/or stipends provided per protocol/contract.
Participates in educational opportunities to increase knowledge about oncology and clinical research.
May lead projects or coordinate team efforts.
Assist with onboarding and training research staff.