Southeast Georgia Health System has an opportunity for a Coordinator, Clinical Research
to join our Research and Development
Responsible for the overall leadership and direction of all clinical research operations including fiscal management, study and site operations, program development, regulatory, and patient recruitment. Responsible for developing strategies, plans and managing clinical studies. Ensures compliance with federal regulations, protocol development and publishing.Essential Responsibilities:
- Researches opportunities to identify potential clinical research studies, evaluates feasibility thereof and initiates studies to evaluate effectiveness of services with regard to objectives, service and cost. Develops and monitors the related clinical research operations budget.
- Provides clinical oversight and direction with respect to the execution of clinical trials, assesses performance and develops action plans to address performance gaps.
- Assesses organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures. Evaluates, creates and maintains all related standard operating procedures.
- Develops, implements, and evaluates programs to promote the recruitment, retention and continuing education of the staff.
- Prepares necessary presentations to keep administrative team abreast of issues, progress, and risks related to trial operations. Completes submissions to independent review boards and other involved third-party entities. Plans and facilitates meetings and committees to address clinical research issues.
- Oversees all aspects of patient treatment associated with trial execution including enrollment, patient consent, lab work, protocol compliance and manage patient enrollment database to ensure integrity of information, providing recommendations for corrective action when necessary.
- Performs and reports on internal audits and coordinates external audit processes.
- Bachelor's or Master's degree preferred.
- 3+ years clinical research experience including clinical trials, clinical trial start up, following Good Clinical Practice and Office for Human Research Protection guidelines, knowledge of industry regulations.
- NIH Certification Protection of Human Research Participants required. Association of Clinical Professionals Certification (ACRP) or Certified Clinical Research Professional (CCRP) required.
- Excellent organizational, interpersonal, and communication skills (oral, written and presentation), problem solving and customer service skills. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Computer skills.
All team members of Southeast Georgia Health System will promote service excellence by developing and maintaining positive relationships with customers, other team members, and the medical staff and will ensure the highest quality of care by performing their responsibilities according to the highest professional standards.Job Type: