What are the responsibilities and job description for the Clinical Studies Coordinator III, Dermatology position at Wake Forest?
JOB SUMMARY
Under departmental direction, coordinates activities to support multiple research studies of all phases and all levels of complexity, including investigator-initiated, IND, First-In-Human, gene therapy or other high profile trials. Functions independently and proficiently with minimal oversight. Serves as the principal administrative liaison for assigned studies and as a technical resource for the department. 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. Mentors and supports new and less experienced staff.
EDUCATION/EXPERIENCE
Bachelor's degree with four years' experience as a clinical research coordinator; or an equivalent combination of experience and education. Master's degree preferred.
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
- 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.
- Mentors new and less experienced staff.
- 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.
- Performs other related duties as assigned or requested.
SKILLS/QUALIFICATIONS
- EPIC/WakeOne proficiency to include appropriate documentation of research notes
- Good interpersonal and communication skills (verbal, non-verbal, and listening skills)
- Proficient in the use of OnCore/WISER Clinical Trial Management System
- Basic computer skills required
- Excellent oral/written communication and organizational skills
- Excellent reading comprehension
- Foster/promote 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
