The Social/Clinical Research Specialist will coordinate and conduct clinical research trials in a manner that ensures quality, consistency, timeliness, accuracy, and patient safety. The Social/Clinical Research Specialist carries out responsibilities in accordance local, state, and federal laws and guidelines.
Establishes and maintains frequent face-to-face, written, and telephone contact with various personnel involved with the research study, including but not limited to subjects, relatives/friends of subjects, doctors, pharmaceutical sponsors, pharmacists, and all levels of research staff. Functions in the role of Primary or Back-up coordinator on assigned clinical trials. Tracks and submits all AE/SAEs and safety reports to the Sponsor within 24 hours as well as the IRB and obtain medical records for SAEs. Reviews medical records to abstract information necessary to complete forms. Identifies, evaluates, and recruits qualified potential subjects for the clinical research trial assigned including obtaining pertinent medical records for new subjects enrolled. Communicate potential subjects to the appropriate PMG Provider and MA. Obtain Informed Consent. Receive and process revised consents including filing in the Trail Master File, notifying personnel, flag new consent in all active and pre-made source charts. Prepare and review template source documents and source charts. Is thoroughly familiar with the protocol, case report form, all pertinent study supplies, and required documentation. Coordinates and conducts pre-study, initiation, monitoring, and close-out visits with the pharmaceutical representative.
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Full time or Part time: Part Time
Position Location (city): Greenville
Position Number: T12416
Organizational Unit Overview:
The Division of Health Sciences is the largest and most complex division within the University, employing more than 700 EPAemployees and 1,700 SPA employees. The Division is composed of numerous Centers, Institutes, and agencies such as East Carolina Heart Institute and Eastern Area Health Education Center, the Colleges of Allied Health Sciences, Nursing, the Brody School of Medicine, the School of Dental Medicine, and the Laupus Health Science Library. In addition to the Academic and Administrative responsibilities of the division, the four professional schools provide clinical services throughout eastern North Carolina in a variety of settings and venues.
The School of Dental Medicine is composed of ten administrative offices and four academic departments. The Administrative units include the Offices of the Dean, Vice Dean, Associate Dean for Student Affairs, Associate Dean for Research, Innovation and Discovery, Associate Dean for Clinical Affairs, Assistant Dean for Extramural Clinical Practices, Assistant Dean for Dental Education and Informatics, Assistant Dean for Educational Support and Faculty Development, Assistant Dean for Academic Success and the Executive Director for Business and Financial Affairs. The four academic departments are Surgical Sciences, Pediatric Dentistry and Orthodontics and Dentofacial Orthopedics, General Dentistry and Foundational Sciences and Research.
Included in the mission of the School of Dental Medicine is to educate dental care providers (both dental students and dental residents) and to address the oral health care needs of the underserved population of North Carolina. The School of Dental Medicine meets these missions by operating dental clinics that provide both educational experiences for the dental students and residents and provides dental care to the residents of North Carolina. These clinics occur in both Ross Hall in Greenville, North Carolina, as well as Community Service Learning Centers located throughout North Carolina. In order to operate these clinics, appropriate dental auxiliaries and clinical staff are needed.
How to apply
Special Instructions To Application:
- Please ensure your full range of knowledge, skills, abilities, experience and education are listed on your application. Do not write ‘see resume’ on your application when completing the job duties section.
- If you answer the questions at the end of the application, please ensure your application reflects the knowledge, skills, abilities and experiences to support your answers (see job duties section of previous employment).
- Failure to answer the questions at the end of the application will not preclude your application from being considered but may result in your application not receiving full consideration of your knowledge, skills, and abilities.
- All applications must be submitted by 11:59 p.m. (EST) on the closing date indicated.