Clinical Research Coordinator - Department of Neuroradiology

West Virginia University

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About The Position

The Department of Neuroradiology at West Virginia University is currently accepting applications for a Clinical Research Coordinator in the School of Medicine.
About the Opportunity
Coordinates and manages clinical trials/protocols within the Department ensuring adherence to protocol requirements and regulatory guidelines. Manages the implementation, system administration and maintenance of patient databases including but not limited to the collection, analysis, and reporting of patient outcomes data. As the primary resource for the protocols, the Clinical Research Coordinator will act as a liaison between the investigators, primary care providers, the Institutional Review Board (IRB), the sponsor, study subjects and study team. Along with the investigator, the CTRS will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the CTRS will assist the Primary Investigator with all aspects of data and source documentation, adverse experience reporting and maintenance of complete regulatory files. In additionally the CTRS will be responsible for patient education, case management with follow up phone calls, tracking of costs per case and clinical outcomes.
We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:
• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year (employee leave)
• 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6%25 employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ’s.
• Wellness programs

Requirements

• Bachelor’s degree in a scientific, healthcare, or other related field.
• A minimum of three (3) years of experience in the following:
• General research experience.
• Experience in clinical setting.
• Any equivalent combination of related education and/or experience will be considered.
• All qualifications must be met by the time of employment.
• Prior clinical research and trial experience desired.
• Excellent written, oral, and interpersonal communication skills.
• High degree of computer literacy, MS Office products.
• Planning skills in scheduling of patients, physicians, site visitors and facility usage are critical. Analysis of protocols, feasibility of studies based on patient populations, financial considerations, facility capabilities, technical support and other support systems is imperative.
• Ability to work independently.
• Analytical skills include the technical aspects of gathering data for purposes of study-related activities.
• Careful attention to detail.
• Excellent organization skills and ability to prioritize a variety of tasks.

Nice To Haves

• Licensed Practical Nurse, Medical Assistant, or other relevant medical education, certification, or licensure.
• Master's degree preferred.

Responsibilities

• Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility and provides administrative and regulatory management of protocols and clinical trials ensuring compliance with WVU IRB, GCP guidelines and code of federal regulations.
• Prepares protocols and ongoing amendments for initial IRB submission including preparation of IRB Protocol Statement, Abstract, Consent and Assent Forms and Discussion.
• Develops a mechanism for subject recruitment and ongoing communications with the primary care physician and nursing staff and serves as a liaison between the WVU IRB, PI and Sponsor or Sponsor’s representative, as appropriate.
• Prepares Annual Protocol Reviews and Study Summaries for submission to WVU IRB. Prepares and reviews clinical trial budgets. Reviews and submits clinical Trial Agreements (including clinical trial budgets) to the WVU Office of Sponsored Programs.
• Coordinates Protocol Review Committee Meetings, and attends other study related meetings as necessary, to ensure peer review of all protocols under consideration for IRB submission.
• Reviews with the PI the inclusion/exclusion criteria, overall structure, and requirements of each protocol and the protocols summary sheet and informed consent form for accuracy and clarity.
• Reviews the protocol, informed consent form, and follow-up procedures with potential study subjects and ensures the informed consent is signed before subjects are screened and enrolled.
• Clinical coordination of protocols and clinical trials, including scheduling follow up visits and testing, assess subject response and review of laboratory data.
• Provides quality assurance for the clinical protocols and investigations, ensuring protocol guidelines are followed.
• Explores and evaluates opportunities for federal, state, private and institutional funding and external presentations, including grant writing and submission.
• Coordinates care management of research patients undergoing treatment in the suite.

Benefits

• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year (employee leave)
• 18 sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6%25 employee contribution match, eligibility to continue health insurance, and other retiree perks.
• Wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees