JOB SUMMARY
Under departmental direction, the Clinical Studies Coordinator II coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor.
EDUCATION/EXPERIENCE
Bachelor’s degree with two years’ experience in clinical research; or an equivalent combination of experience and education.
LICENSURE, CERTIFICATION, and/or REGISTRATION
- SOCRA or ACRP Certification preferred.
- Must complete the CITI certification for Human Subject Research if not already completed.
- All additional required WakeOne training for research coordinators.
SKILLS/QUALIFICATIONS
- Excellent interpersonal, oral, and written communication skills
- Excellent reading comprehension
- Strong organizational skills
- EPIC/WakeOne proficiency to include appropriate documentation of research notes
- Proficient in the use of OnCore/WISER Clinical Trial Management System
- Basic computer skills and knowledge of Microsoft Products
- Fosters/promotes a positive image and professional appearance
- Sensitivity to intercultural relations
- Sensitivity to the maintenance of confidentiality
ESSENTIAL FUNCTIONS
- Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision.
- Plays an active role in recruitment of patients to study.
- Performs protocol specific duties required per the research protocol.
- Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
- Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol.
- Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents.
- Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
- Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis.
- May mentor new and less experienced staff.
- Follows established Atrium Health Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
- Performs other related duties as assigned or requested.
WORK ENVIRONMENT
Clean, comfortable, office environment
Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.
Atrium Health is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest nonprofit health system in the United States, created from the combination of Atrium Health and Advocate Aurora Health. AHWFB is an 885-bed tertiary-care hospital in Winston-Salem – that includes Brenner Children’s Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,700 physicians.
Our highly integrated academic and clinical environment is deeply committed to improving health, elevating hope, and advancing healing – for all.
It should be noted that while you are applying on the Wake Forest University School of Medicine Career Site, you will receive communications from the Atrium Health Recruitment Team. Please know that this is an expected process. Thanks in advance for your flexibility.
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