Incumbent, with supervision/direction from the clinic manager will serve as the coordinator for a variety of clinical trials and/or studies. The major purpose of this position is to provide active leadership and control of all assigned clinical trials and studies in which the department is participating. In addition, the incumbent will perform all usual and necessary diagnostic testing required by those clinical trials to the ability of their level of skills and/or certification. This position will require incumbent to recruit patients for assigned studies which will include chart searches, advertisement, referrals and other means as necessary and directed. Incumbent will work directly with Administrator in fiscal matters and with various internal physicians, external physicians, internal regulation agencies, external regulation agencies, and a variety of patients.
MINIMUM QUALIFICATIONS
EDUCATION, CERTIFICATION, AND/OR LICENSURE:
1. Bachelor's degree.
PREFERRED QUALIFICATIONS
EDUCATION, CERTIFICATION, AND/OR LICENSURE:
1. Bachelor's degree in Nursing.
2. Certification as a Certified Research Assistant/Coordinator.
3. Successful completion of a formal, one year CAAHEP approved training course.
4. Certification at the Certified Ophthalmic Assistant level (COA).
EXPERIENCE:
1. Three years research experience.
CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position. They are not intended to be constructed as an all-inclusive list of all responsibilities and duties. Other duties may be assigned.
1. Classify and maintain all study records within the department to insure that records are in compliance with study guidelines, confidentiality guidelines (both corporate and/or federal).
2. Familiarize and become highly knowledgeable with all study/clinical trials protocols currently assigned to the department.
3. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; obtain blood samples, cultures, tissues and other specimens for laboratory analysis per protocol.
4. Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and Monitor patients' progress to include documentation and reporting of adverse events; recommend corrective action as appropriate.
5. Assures that all protocol-specific activities have been scheduled and/or completed.
6. Interact with scheduling personnel to insure that patients are properly scheduled for initial, return and terminal visits in compliance with study protocols.
7. Liaison with all principal investigators and agencies to insure patients enrolled in studies/trials are properly cared for and that there is 100% compliance with study protocols and/or IRB guidelines.
8. Maintains a good understanding of all elements related to screening and enrolling patients in clinical research studies that he/she is responsible for.
9. Work collaboratively with investigators and study coordinators for study-specific training and communication related to possible or already accrued study participants.
10. Offers general clinical trial and protocol specific information to staff, community, professionals and the public.
11. Determines the need for study-specific training for study team members, patients and/or family members regarding research study requirements to ensure that all relevant individuals adequately understand key elements of the study.
12. Independently participates in activities to increase knowledge base and performance.
13. Ensures compliance with WVU Institutional Review Board, Good Clinical Practice guidelines and federal regulations related to clinical research.
14. Maintains timely and accurate reports of adverse events and protocol deviations to assure proper IRB and/or sponsor notification.
15. Maintains all record of patient visits, compliance and schedules for all patients enrolled into all clinical trials/studies.
16. Maintains timely, study-specific documentation that reflects an accurate, complete, and legible record of study activities.
17. Associated clerical duties as assigned and necessary for each study/trial assigned.
18. Attendance of all appropriate training seminars is required by study/trial agency.
19. Participates in the patient recruitment and enrollment efforts.
PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Requires manual dexterity used in operating office equipment
2. Requires standing and bending in the assessment and treatment of patients
3. Prolonged periods of sitting and the ability to walk moderate distances
4. Some manual work may be included; occasional heavy lifting (patient assistance) and the ability to move equipment.
WORKING ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Work environment is in a normal, clinical office environment.
2. Incumbent is likely to come in contact with patients having communicable disease (URI, HIV, Hepatitis B, TB, usual childhood diseases, etc.)
3. The presence of blood and specimen care and processing is a routine part of this environment.
SKILLS & ABILITIES:
1. Planning skills in scheduling of patients, physicians, site visitors and facility usage are critical.
2. Analysis of protocols, feasibility of studies based on patient populations, financial considerations, facility capabilities, technical support and other support systems is imperative.
3. Analytical skills include the technical aspects of gathering data for purposes of process improvement and aid in pursuing the courses of action directed by the physician and/or clinic manager required for patient care activities.
Additional Job Description:
Scheduled Weekly Hours:
40
Shift:
Day (United States of America)
Exempt/Non-Exempt:
United States of America (Exempt)
Company:
BMC Berkeley Medical Center
Cost Center:
8405 UHAE Physician Services
Address:
2500 Hospital DriveMartinsburgWest Virginia
Equal Opportunity Employer
West Virginia University Health System and its subsidiaries (collectively "WVUHS") is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. WVUHS strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law. All WVUHS employees, other workers, and representatives are prohibited from engaging in unlawful discrimination. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and termination of employment.
The West Virginia University Health System, which operates under the brand WVU Medicine, is West Virginia’s largest health system and the state’s largest employer with more than 3,400 licensed beds, 4,600 providers, 35,000 employees, and $7 billion in total operating revenues. The Health System is comprised of 25 hospitals – including J.W. Ruby Memorial Hospital, an 880-bed academic medical center, and the 150-bed WVU Medicine Golisano Children’s Hospital in Morgantown, West Virginia – and five institutes. To learn more, visit WVUMedicine.org.
