(Hybrid) Clinical Research Specialist

The WV Clinical & Translational Science Institute (WVCTSI) at West Virginia University Research Corporation is seeking applications for a hybrid Clinical Research Specialist (2 openings).

About the Opportunity

As a Clinical Research Specialist, you 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. You will perform a variety of independent and collaborative duties involved in clinical trial coordination and implementation, organization, oversight, documentation, tracking, data abstraction and collection and compilation of clinical research data.

At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs:

* 13 paid holidays (staff holiday calendar)
* PTO
* 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)
* A range of health insurance and various other benefits
* Dependent Education Scholarship
* WVU Perks
* And More

What you'll do:

I. Protocol Compliance: Facilitate compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of the needs of diverse patient populations.

* Identify the requirements of various types and phases of clinical trials, including objectives, sample sizes, and patient care needs.
* Identify sources for and facilitate adherence to current regulations, guidance, and policies that affect research at the institutional, state, federal, and international levels.
* Promote compliance with the varied processes and procedures required by different types of sponsors (e.g., private industry, National Institute of Health, investigator-initiated).
* Protect patient, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
* Participate in discussions regarding feasibility of protocol implementation based on knowledge of institutional capabilities and limitations, therapy, or population of interest.
* Comply with the International Air Transport Association and institutional policies for shipping and receiving biological specimens, experimental agents, and devices.
* Collaborate with the research team to implement procedures for maintaining patient study participation from enrollment through completion.
* Identify the institutional review board (IRB) of record (local, central, or commercial), protocol-related policies of the IRB, and preferred contact method.
* Participate in providing timely, informative, and accurate communication to the IRB as required.
* Facilitate and participate in the preparation for and implementation of 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.
* Ensure validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events.
* Collaborate 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: Utilize multiple communication methods to facilitate the effective conduct of clinical trials.

* Ensure 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.
* Provide general clinical research as well as trial-specific information to research, clinical, and other organizational staff.
* Develop relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials.
* Participate in study initiation meetings.
* Provide education related to clinical trials to patients and their significant others.
* Advocate 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: Demonstrate leadership in ensuring patient comprehension and safety during initial and ongoing clinical trial informed consent discussions.

* Ensure 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.
* Participate 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.
* Assess 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.

* Collaborate with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol.
* Ensure adherence to the protocol schedule of events and other requirements.
* Ensure scheduling of all procedures required to assess for adverse events and disease response to the study intervention.
* Ensure the successful completion of correlative components of the clinical trial (e.g., pharmacokinetic, pharmacoeconomic, and quality-of-life studies).
* Assess patients for trial-related and non-trial-related symptoms and ensures evidence-based symptom management while maintaining trial compliance.
* In collaboration with the investigator, assess patients for adverse events and then document and report these findings per the protocol and FDA, sponsor, and IRB policies.
* Utilize 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.
* Review disease response results and physical assessment data in conjunction with the principal investigator to determine response per the protocol.
* Support and evaluate patient adherence to the protocol by utilizing various methods to assist with documentation, patient education, and study agent return.
* Identify vulnerable patients who require increased nursing assessment and management in addition to the clinical trial requirements.

V. Documentation: Provide leadership to the research team in ensuring collection of source data and completion of documentation that validate the integrity of the conduct of the clinical trial.

* Comply with regulations, institutional policies, and sponsor requirements governing source data and documentation.
* Document assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol and role.


* Ensure 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.
* Follow 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.
* Ensure that all regulatory documents are processed and maintained per institution, IRB, and GCP regulations.
* Demonstrate proficiency in the use of clinical and research-related computer programs.



VI. Patient Recruitment: Utilize a variety of strategies to enhance recruitment while being mindful of the needs of diverse patient populations.

* Assist 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: Demonstrate 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.

* Advocate for ethical care of clinical trial patients and the conduct of clinical trials in accordance with standards of nursing practice.
* Promote ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, and respect for persons, beneficence, and justice.
* Ensure that members of vulnerable populations enrolled in clinical trials are identified and that their rights are addressed.
* Identify and follow institutional procedures to report any falsification of data or scientific misconduct.

VIII. Financial Implications: Identify the financial variables that affect research and supports good financial stewardship in clinical trials.

* Describe the key components included in study budgets and institutional resources for budget details.
* Ensure and track submission of specified items (e.g., completed case report forms, specimens) to facilitate timely recovery of protocol-related activity costs.
* Ensure that stipends to patients for protocol-related activities are disclosed to the IRB during approval of the consent form.

IX. Professional Development: Take responsibility for identifying ongoing professional development needs and seek resources and opportunities to meet those needs, such as through membership in nursing, disease specialized (i.e., oncology nursing society), or research organizations.

* Participate in educational opportunities to increase knowledge about clinical trials, regulations and guidance, and the role of the clinical trials nurse.
* Seek resources on an ongoing basis that provide clinical treatment and nursing practice updates, such as through professional mentoring and meetings, journals, and Web sites.


* Bachelor's degree in an allied health discipline, or related medical field and/or RN degree, or an equivalent combination of education and directly related experience.
* A minimum of five (5) years of experience working in a clinical setting and/or experience working in clinical research.
* 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.



Certifications:

* Within two (2) years of employment, incumbent must obtain certification as a Research Coordinator through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA).
* If qualifying with an RN degree, must be licensed in state of WV or eligible for licensure in WV.

Preferred Qualifications:

* A minimum of two (2) years of experience in critical care or specialized nursing unit.