Clinica Research Coordinator IV

About the role

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. They serve as a liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D.

Responsibilities

• Recruit, screen, and enroll eligible study participants.
• Obtain informed consent from study participants.
• Manage completion and submission of study related documentation.
• Communicate 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.
• Monitor enrollment goals and implement action plans, as needed.
• Cover tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team.
• Collect 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.
• Track and report adverse events and protocol deviations.
• Cover site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure.
• Prepare, submit, and maintain IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence.
• Develop and maintain 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.
• Demonstrate competency managing multiple complex studies and significant workload.
• Provide in-depth clinical research training and mentorship to junior and intermediate CRCs.
• Contribute to trial planning, development, and implementation activities.
• Provide education and support throughout the research process to all members of the research team and to ancillary departments involved in research.
• Aid in protocol feasibility determination, identifying potential barriers and proactively solving problems.
• Aid in developing data collection systems and compiling study-related reports.
• Aid in writing research grant proposals, manuscripts, study materials, brochures, and correspondence.
• Act as a champion for clinical research at Carilion Clinic.

Requirements

• 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.

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.

Skills

• Excellent computer skills.
• Strong knowledge of word processing, spreadsheets, databases, and internet environment.
• Knowledge of medical and/or pharmaceutical terminology.
• Strong organization and communication skills.
• Able to work with multiple interruptions and to perform multiple tasks at any given time.
• Strong leadership, interpersonal and teamwork skills.

Benefits

N/A

Pay

$63,377.60 - $95,076.80

Schedule

N/A