Responsible for the overall leadership and direction of all clinical research operations including but not limited to fiscal management, study and site operations, regulatory processes and patient recruitment. The Lead Clinical Research Coordinator is responsible for developing growth strategies, and managing and/or coordinating clinical studies.
Promote business growth with PENTA Investigators and increase visibility within the Pharmaceutical Industry. Ensure subject safety across all trials.
Assess clinical trials in terms of study's impact on site resources, labor cost, cost by procedure and practice suitability. Complete site feasibilities, facilitate sponsor pre-site visits and secure clinical trials for the PENTA research department.
Coordinate Phase I through Phase IV clinical pharmaceutical trials. Duties include obtaining suitable patients who meet all admission criteria, assisting with patient education, adhering to the study protocol and maintaining proper documentation according to the protocol and regulatory requirements. Documenting laboratory data and adverse reaction, correcting discrepancies, anticipating possible problems and resolutions, maintain communication with the monitor from the sponsoring company, and performing technical requirements of the protocol which included phlebotomy.
Develop and implement the marketing plan for PENTA research as well as the recruitment plan for each enrolling study. Monitor subject accrual rates and implement action plans for accrual issues.
Complete all IRB documents to obtain regulatory approval. Manage annual reports to the IRB. Document protocol deviations and report to the IRB as required.
Develop the budget for each study and perform negotiations with study sponsors. Invoice sponsors as required and prepare the allocation spreadsheet for each check. Manage research expenses. Review and approve study contracts.
Develop and revise the PENTA research SOP's. Ensure research staff adherence to SOP's and all federal requirements.
Train and supervise support staff ensuring adherence to protocol and regulatory requirements.
Manage special projects and other research initiatives as assigned.
Relevant degree (e.g., Bachelor's degree in a relevant discipline such as Health Administration, Nursing, or Business) or equivalent combination of experience and education (certification CCRC).
At least 5 years' experience pharmaceutical research experience including previous supervisory experience.
Knowledge of ICH GCP, CFR guidelines and industry requirements.
Clinical knowledge to perform clinical duties. (Phlebotomy, ECG's)
IATA certification-knowledge in specimen processing and shipment
Oral/written communication skills
People management (supervision)
Problem solving skills
Customer Service Oriented
About Piedmont Ear, Nose and Throat Associates
Piedmont Ear Nose and Throat Associates was formed in 1999, when five doctors, Dr. William S. Fisher II, Dr. Ronald B. Shealy, Dr. Robert M. Alsup, Dr. Kenneth S. Maxwell and Dr. Stephen B. Potts, from Salem ENT and Forsyth Head & Neck, joined forces to better serve the community. “From day one, our goal was to provide the highest quality ENT care in the region,” Potts says. “Our providers and staff are dedicated to delivering the best patient care possible through teamwork, integrity, knowledge and passion. Twenty years later, PENTA remains a privately owned, physician-led surgical practice. This group of five doctors has now grown to 12 physicians, one physician assistant and a staff of more than 60 people. Services offered include general adult and pediatric ENT, audiological testing, hearing aid sales and service, allergy testing and treatment, clinical research, facial plastic surgery, cosmetic injectables, aesthetic products and services. Our focus on our patients and quality care has never wavered.The best physicians and advance practice providers choose PENTA because of a shared commitment to our community and to each other. We’re glad you are interested in joining our te...am.We are seeking a lead research candidate to join our Winston Salem location. At Piedmont Ear Nose and Throat Associates you will work in an environment that is supportive both professionally and personally.