TEMPORARY CLINICAL RESEARCH COORDINATOR CERTIFICATE TRAINEE

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 with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for experimental devices or drugs as indicated.

II. 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.

III. 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.

IV. 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.

V. Documentation: 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 as recommended by good clinical practices, standards, or institutional procedures.
* 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.

VI. Patient Recruitment: 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, taking into consideration the study entry criteria, required procedures, and other potential factors.

VII. Ethical Issues: Demonstrates leadership in ensuring adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data.

* 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.

VIII. Financial Implications: 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 (e.g., completed case report forms, specimens) 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.

IX. Professional Development: Takes responsibility for identifying his or her ongoing professional development needs and seeks resources and opportunities to meet those needs, such as through membership in nursing, disease specialized or research organizations.

* 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, such as through professional mentoring and meetings, professional development seminars, monthly journal club, journals, and Web sites.

* Bachelor's degree, or an equivalent combination of education and experience.
* 0-6 months of related experience.
* 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.

---