(Temporary) Clinical Research Coordinator Certificate Trainee - WV Clinical & Translational Science Institute

West Virginia University•West Virginia, WV

6d•Onsite

About The Position

The West Virginia Clinical & Translational Science Institute (WVCTSI) at West Virginia University is seeking a Temporary Clinical Research Coordinator Certificate Trainee. This role involves enrollment in the ISOCRE-RC Clinical Research Coordinator Development Program (CRCDP). Under preceptor supervision, trainees will complete 400 hours of experiential training and approximately 60 hours of self-paced didactic learning. The program aims to equip trainees with essential skills for a career as a clinical research coordinator or specialist, building workforce capacity for clinical trials research. Responsibilities include participating in the development, coordination, and implementation of research and administrative strategies for Phase II/III/IV clinical trials at the WVU Health Sciences Center, involving oversight, documentation, data abstraction, and collection.

Requirements

Bachelor's degree in a 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 treatment design, administration and modification.
Must possess and apply knowledge of counseling and education – principles and methods for training design, teaching and instruction for individuals and groups, and the measurement of training effects.
Must possess and apply knowledge of data collection, validation, entry, analysis, and reporting.
Must possess and apply knowledge of 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.
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.
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

Facilitates compliance with research protocol requirements and good clinical research practice, considering diverse patient populations.
Identifies requirements for various clinical trial types and phases, including objectives, sample sizes, and patient care needs.
Identifies sources for and facilitates adherence to current regulations, guidance, and policies affecting research at institutional, state, federal, and international levels.
Promotes compliance with processes and procedures required by different sponsors (e.g., private industry, NIH, investigator-initiated).
Protects patient, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
Observes discussions regarding the feasibility of protocol implementation based on institutional capabilities and limitations.
Complies with IATA 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 and protocol-related policies.
Participates in providing timely, informative, and accurate communication to the IRB.
Observes meetings with external and internal monitors and auditors, including the FDA, Medicare reviewers, 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 the principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for experimental devices or drugs.
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, including frequent communication and periodic meetings with the principal investigator.
Provides general clinical research and trial-specific information to research, clinical, and other organizational staff.
Participates with preceptors in developing relationships with referring physicians, clinical staff, and ancillary departments.
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 and for the promotion and integrity of the clinical trial.
Ensures the initial and ongoing consent process is performed and documented in compliance with FDA, ICH GCP, institutional, sponsor, IRB, and other applicable regulations.
Participates in the education of clinical trial patients about their clinical trial and significant new information.
Assesses for barriers to effective informed consent discussions and implements plans to overcome them.
Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol.
Assists with 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.
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.
Assists with providing collection of source data and completion of documentation that validate the integrity of the conduct of the clinical trial.
Complies with regulations, institutional policies, and sponsor requirements governing source data and documentation.
Documents assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol and role.
Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.
Follows appropriate guidelines in making corrections to data entry in clinical records and case report forms.
Ensures that all regulatory documents are processed and maintained per institution, IRB, and GCP regulations.
Demonstrates proficiency in the use of clinical and research-related computer programs.
Assists with a variety of strategies to enhance recruitment while being mindful of the needs of diverse patient populations.
Assists in implementation of recruitment plans to identify and assess individuals who might be eligible for clinical trials.
Advocates for ethical care of clinical trial patients and the conduct of clinical trials in accordance with standards of nursing practice.
Promotes ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, and respect for persons, beneficence, and justice.
Ensures that members of vulnerable populations enrolled in clinical trials are identified and that their rights are addressed.
Identifies and follows institutional procedures to report any falsification of data or scientific misconduct.
Assists with identifying the financial variables that affect research and supports good financial stewardship in clinical trials.
Understands the key components included in study budgets and institutional resources for budget details.
Assists with tracking submission of specified items to facilitate timely recovery of protocol-related activity costs.
Assists with ensuring that stipends to patients for protocol-related activities are disclosed to the IRB during approval of the consent form.
Takes responsibility for identifying his or her ongoing professional development needs and seeks resources and opportunities to meet those needs.
Participates in educational opportunities to increase knowledge about clinical trials, regulations and guidance, and the role of the clinical trials nurse.
Seeks resources on an ongoing basis that provide clinical treatment and nursing practice updates.