CT Surgery Clinical Studies Coordinator II
About The Position
This position works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision. The Clinical Studies Coordinator II plays an active role in patient recruitment for studies, performs protocol-specific duties, and obtains or assists the Principal Investigator in obtaining informed consent from subjects. They are responsible for fulfilling sponsor requirements related to reportable information, including adverse events and unanticipated problems. The role involves abstracting data from medical records, completing case report forms, and maintaining source documents. This position identifies and communicates important protocol and data management issues to the supervisor, provides staff relief as needed, and participates in team/department meetings and quality improvement projects. Additionally, the role may involve mentoring new staff and adhering to all Wake Forest Baptist and department policies, procedures, and guidelines, including the Code of Conduct and Compliance Plan, while practicing a high level of integrity and honesty in maintaining confidentiality. Other related duties may be assigned or requested.
Requirements
- Bachelor's degree with two years experience in clinical research; or an equivalent combination of experience and education.
- 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.
- 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
Nice To Haves
- SOCRA or ACRP Certification
Responsibilities
- 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.
- 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.
Benefits
- Comprehensive suite of Total Rewards: benefits and well-being programs
- Competitive compensation
- Generous retirement offerings
- Programs that invest in your career development
- Paid Time Off programs
- Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Family benefits such as adoption assistance and paid parental leave
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
