Clinical Studies Coordinator II, Infectious Disease

The primary focus of the Atrium Health Wake Forest Baptist Infectious Disease Clinical Trials Unit is on ambulatory studies involving HIV/AIDS, viral hepatitis, and other infectious diseases including COVID-19.  Occasional evening and weekend work may be required as job duties demand.

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 in a related field of study with two years' experience in clinical research; or an equivalent combination of experience and education.
• Experience in public health and/or infectious diseases research desired.
• Experience with HIV, sexually transmitted infections, sexual health, and/or oncology care preferred.
• Experience with Electronic Medical Record systems and/or Clinical Trial Management systems.

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.
• Phlebotomy certification preferred.

ESSENTIAL FUNCTIONS

1. Work under the direction of the Study Investigators and Project Manager with minimal supervision.
2. Read assigned protocols and associated study materials to ensure an understanding of how each study is to be conducted.   Conduct each study as described in the protocol.
3. Responsible for recruiting patients for clinical studies.  Track the sources of patient referrals which include referring physicians, Medical Center laboratories, and other sources.  Screen potential subjects for eligibility.  Schedule subjects for study visits.
4. Perform technical procedures (vital signs, EKG’s, blood draws, urine pregnancy tests, etc.) on clinical subjects under the direction of the principal investigator or his/her designee(s).  Process biologic specimens (blood, urine, tissue samples) for appropriate shipping and storage.  Order labs/procedures to be performed by NCBH Pathology.
5. Perform all aspects of the data collection, reporting, auditing, and querying process for clinical trials.  This may include the development of data collection forms.  Assist with organizing the files for long-term archiving.
6. Maintain appropriate study subject records (source documents) as necessary.  This includes charting the condition of the patient and determining their continued eligibility in the study by obtaining and interpreting pertinent data from electronic and paper medical records. 
7. Perform day-to-day administrative and clerical duties such as regulatory document submission, IRB updating, adverse event reports, etc. 
8. Consult and cooperate with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study.  
9. Perform other related duties incidental to the work such as attending Investigator Meetings, preparing for monitoring visits, etc.
10. Serve as a back-up coordinator for studies in case of primary coordinator’s absence.      Assist other coordinators as needed. 
11. Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
12. Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
13. Participates in scheduled team/department meetings.  Participates in quality improvement projects on an on-going basis.
14. May mentor new and less experienced staff.
15. 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.

SKILLS/QUALIFICATIONS

• Excellent interpersonal, oral, and written communication skills
• Excellent reading comprehension
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