Job Details

Clinical Research Coordinator

Make the most of your clinical skills at an organization that has earned numerous awards for clinical excellence. Based in Roanoke, VA, our community-based health care organization encompasses a comprehensive network of hospitals, primary and specialty physician practices, and other complementary services. The Clinical Research Coordinator 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. Training for competency based research procedures including Phlebotomy, Vital signs, Basic Life support (BLS) will be provided. Play an important role with a regional leader that inspires better health through compassionate care, medical education and research, and neighborhood outreach. Realize the advantages of advancing your career with an organization where you can expect supportive leadership, state-of-the-art technological resources, inter-professional teamwork, and innovative learning.

The Clinical Research Coordinator 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 greater workload.
• Provides in-depth clinical research training and mentorship to junior 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.

Education: Bachelor's degree in science or related field required. Master's Degree preferred.

Experience: Minimum of three (3) years of Clinical Research (or equivalent research experience) AND a Master's Degree in Science or related field OR Minimum of five (5) years of Clinical Research (or equivalent research experience) AND a Bachelor's Degree in Science or related field 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.