Clinical Studies Coordinator II - Pediatrics

About the role

The Clinical Studies Coordinator II supports multiple research studies of all phases at Wake Forest University Health Sciences - Pediatrics. This position serves as the principal administrative liaison for assigned studies, managing a workload that includes studies of increased complexity.

Responsibilities

• 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.
• Compiles, registers, and submits data as required by the Sponsor.
• Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision.
• Recruits patients to study and performs protocol-specific duties as per the research protocol.
• Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information 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 ongoing basis.
• May mentor 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.

Requirements

• Bachelor's degree with two years of experience in clinical research; or an equivalent combination of experience and education.
• Preferred: SOCRA or ACRP Certification, CITI certification for Human Subject Research (will complete upon hire if not already completed).

Qualifications

• Excellent interpersonal, oral, and written communication skills.
• 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 and confidentiality.
• Knowledge of Microsoft Products.

Skills

• Excellent reading comprehension.
• 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 and confidentiality.
• Knowledge of Microsoft Products.

Benefits

Advocate Health offers a comprehensive suite of Total Rewards including:

• Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training.
• Premium pay such as shift, on call, and more based on a teammate's job.
• Incentive pay for select positions.
• Opportunity for annual increases based on performance.
• Benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development, and so much more.