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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.
Job Responsibility:
Coordinates activities to support multiple research studies of all phases and all levels of complexity
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 recruitment, administering questionnaires
Responsible for the compilation, registration and submission of data, as required by the Sponsor
Mentors and supports new and less experienced staff
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
Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems
Abstracts data from the medical record and completes paper and electronic case report forms
Identifies and communicates important protocol and data management issues or problems to the supervisor
Provides staff relief as required to meet the needs of the department
Participates in scheduled team/department meetings
Participates in quality improvement projects
Follows established Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines
Performs other related duties as assigned or requested
Requirements:
Bachelor's degree with four years' experience as a clinical research coordinator
or an equivalent combination of experience and education
Master's degree preferred
SOCRA or ACRP Certification preferred
Must complete the CITI certification for Human Subject Research
All additional required WakeOne training for research coordinators
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
Nice to have:
Master's degree
SOCRA or ACRP Certification
What we offer:
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
Premium pay such as shift, on call, and more
Incentive pay for select positions
Opportunity for annual increases based on performance