Employment Status:Full timeShift:Day (United States of America)Facility:101 Elm Ave - RoanokeRequisition Number:R160297 Clinica Research Coordinator IV (Open) How You’ll Help Transform Healthcare:The Clinical Research Co…
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$63k–$95k/yr
Full-time
bachelor degree, postgraduate degree
Medical Benefits, Dental Benefits, Vision Benefits, Employer Funded Pension Plan, Voluntary 403B, Paid Time Off
Posted 67d ago
Apply by Jul 21
~40 hrs/week
Responsibilities
Manages administrative activities for industry, grant, or internally funded research studies while ensuring compliance with governing agencies and institutional policies. Acts as a primary liaison between sponsors, IRBs, and medical staff while mentoring junior research coordinators.
Requirements
Requires a Bachelor's degree in science with 15 years of experience, or a Master's degree with 10 years of experience. Must hold a SoCRA or ACRP certification upon hire and IATA certification for specimen transport.
Full job description
Employment Status:
Full time
Shift:
Day (United States of America)
Facility:
101 Elm Ave - Roanoke
Requisition Number:
R160297 Clinica Research Coordinator IV (Open)
How You’ll Help Transform Healthcare:
The Clinical Research Coordinator IV Manages administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. Serves as liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D.
The Clinical Research Coordinator IV Manages administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. Serves as liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D.
Recruit, screen, and enroll eligible study participants.
Obtain informed consent from study participants.
Manages completion and submission of study related documentation.
Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance.
Monitors enrollment goals and implements action plans, as needed.
Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team.
Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
Collect, process, and ship research specimens as directed in the protocol.
Ensure compliance with study protocol and requirements of regulatory agencies.
Tracks and reports adverse events and protocol deviations.
Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure.
Prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence.
Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log.
Demonstrates competency managing multiple complex studies and significant workload.
Provides in-depth clinical research training and mentorship to junior and intermediate CRCs.
Contributes to trial planning, development, and implementation activities.
Provides education and support throughout the research process to all members of the research team and to ancillary departments involved in research.
Assists with protocol feasibility determination, identifying potential barriers and proactively solving problems.
Assists in developing data collection systems and compiling study-related reports. Assists in writing research grant proposals, manuscripts, study materials, brochures, and correspondence.
Acts as a champion for clinical research at Carilion Clinic.
What We Require:
Education: Bachelor's degree in science or related field required. Master's degree in science or related field preferred.
Experience: Minimum of ten (10) years of Clinical Research (or equivalent research experience) AND a master's degree in science OR Minimum of fifteen (15) years of Clinical Research (or equivalent research experience) AND a bachelor's degree in science required.
Licensure, certification, and/or registration: Nationally recognized clinical research certification from Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) required upon hire. I.A.T.A. (International Air Transport Association) certification is required for projects that will be transporting specimens prior to completion of IRB application.
Other Minimum Qualifications: Excellent computer skills; strong knowledge of word processing, spreadsheets, databases, and internet environment. Knowledge of medical and/or pharmaceutical terminology strongly desired. Strong organization and communication skills required. Able to work with multiple interruptions and to perform multiple tasks at any given time. Must have strong leadership, interpersonal and teamwork skills.
This job description is only meant to be a representative summary of the major responsibilities and accountabilities performed by the incumbents of this job. The incumbents may be requested to perform job-related tasks other than those stated in this description.
Compensation Range:
$63,377.60 - $95,076.80
Employee pay is based on a variety of factors, including qualifications, credentials, education, and prior work experience. The compensation range does not include benefits or pension plan.
For more information, contact the HR Service Center at 1-800-599-2537.
Carilion Clinic is an Equal Opportunity Employer: We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age (40 or older), disability, genetic information, or veterans status. Carilion is a Drug-Free Workplace. For more information or for individuals with disabilities needing special assistance with our online application process contact Carilion HR Service Center at 800-599-2537, 8:00 a.m. to 4:30 p.m., Monday through Friday.
Carilion understands the importance of prioritizing your well-being to help you develop and thrive. That’s why we offer a well-rounded benefits package, and many perks and well-being resources to help you live a happy, healthy life – at work and when you’re away.
When you make your tomorrow with us, we’ll enhance your potential to realize the best in yourself. Below are benefits available to you when you join Carilion:
Comprehensive Medical, Dental, & Vision Benefits
Employer Funded Pension Plan, vested after five years (Voluntary 403B)
Paid Time Off (accrued from day one)
Onsite fitness studios and discounts to our Carilion Wellness centers
Access to our health and wellness app, Personify Health
Carilion Clinic is a non-profit health care organization serving nearly one million people in Virginia through hospitals, outpatient specialty centers and advanced primary care practices. Led by multi-specialty physician teams with a shared philosophy that puts the patient first, Carilion is committed to improving outcomes for every patient while advancing the quality of care through medical education and research. For more information, visit CarilionClinic.org.
Any text, graphics or images are for informational purposes only and not intended to be relied upon solely for medical advice nor as promotional endorsements of any third parties.
Offices: P.O. Box 13367, Roanoke, Virginia 24033, US · 1906 Belleview Ave SE, Roanoke, VA 240414, US
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