Clinical Studies Coord II

JOB SUMMARY: Under departmental direction, 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. 

ESSENTIAL FUNCTIONS: 

1. Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision. 

2. Plays an active role in recruitment of patients to study. 

3. Performs protocol specific duties required per the research protocol. 

4. Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families. 

5. Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol. 

6. 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. 

7. Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner. 

8. 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. 

9. May mentor new and less experienced staff. 

10. Follows established 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.

11. Performs other related duties as assigned or requested. 

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 Fosters/promotes a positive image and professional appearance Sensitivity to intercultural relations Sensitivity to the maintenance of confidentiality Knowledge of Microsoft Products 

WORK ENVIRONMENT: Clean, comfortable, office environment 

Atrium Health Wake Forest Baptist is a pre-eminent academic health system based in Winston-Salem, North Carolina. Atrium Health Wake Forest Baptist 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. Atrium Health Wake Forest Baptist’s two main components are an integrated clinical system – anchored by Atrium Health Wake Forest Baptist Medical Center, 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; and Wake Forest School of Medicine, the academic core of Atrium Health Enterprise and 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.

Wake Forest Baptist Health, Wake Forest University School of Medicine and Atrium Health have joined forces in a strategic combination that will enhance care, transform medical education and create economic opportunity for countless lives in North Carolina and beyond. As a part of that combination, the two health systems will be integrating technology and platforms, including our career sites.

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