Clinical Studies Coordinator II - Pediatric Research

Overview

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.

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

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.

WORK ENVIRONMENT

Clean, comfortable, office environment