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Department: 480502 - HR UTS/UNC Partnership
Location: Chapel Hill, NC
Essential Job Duties:
The department is seeking a clinical research coordinator to join the team. The department provides centrally managed study coordination and project management services to a variety of clinical research projects and investigators across UNC.
The clinical research coordinator will provide independent study support to a variety of clinical research studies and trials. This position will work closely with the program manager, project manager, colleagues, and study teams to plan and execute complex research trials. The clinical research coordinator will execute study protocols, including participant recruitment/enrollment, conducting study procedures, collecting and maintaining data, tracking and reporting study progress, and ensuring quality and accuracy across a variety of therapeutic areas and protocols of varied complexity. Additionally, the coordinator will lead study start-up activities, including creating study protocols and materials, developing regulatory documents, and establishing effective study workflows.
Primary duties will include:
Day-to-day operations and coordination for research studies across various therapeutic areas: recruit, consent and enroll participants to research studies, conduct study visits and collect data per study protocol, perform study procedures (may include clinical procedures, specimen collection/processing/handling, interviewing, administering questionnaires, etc.), complete case report forms and data entry, track study progress and maintain appropriate logs and records, respond to data queries and facilitate monitoring/auditing visits. Engage professionally with study personnel, investigators, sponsors and service providers to ensure smooth and efficient study progress. Maintain good clinical practice and compliance with all regulatory bodies and study protocols. Work closely with study teams, Principal Investigators and Senior Coordinators to ensure efficient and successful management of research protocols. Complete regulatory documentations for submission and maintain approvals. Track study progress, meet deadlines, identify areas for quality improvements, recommend and implement improvements. Work collaboratively within the department to streamline research processes and implement innovative solutions to increase efficiencies. Participate in continuing education activities, including teaching, mentoring and learning on an ongoing basis. Communicate effectively with a variety of research, clinical and administrative professionals. Provide reports, data summaries and project recommendations to study teams and Principal Investigators, as well as a variety of stakeholders
Completion of a bachelor's degree or higher Experience engaging with patients and executing research in a clinical setting Experience with independent management of regulatory processes (IRB submissions and regulatory binders) Excellent communication skills – written and verbal Excellent organizational skills with significant attention to detail Demonstrated professionalism Ability to work independently and as part of a team Proficiency with Microsoft Outlook, Word and Excel
Familiarity with UNC research systems (Epic, CRMS, etc) Experience with complex clinical trials Experience with multiple study funders (e.g. industry, NIH, foundation) Experience in a variety of therapeutic areas Spanish fluency CCRP, CCRC, or other specific clinical research training/credentials
Required license or certification:
Position Number: 48RE31
NC State University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran.
If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or [email protected] Individuals with disabilities requiring disability-related accommodations in the application and interview process, please call 919-515-3148.
Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. If highest degree is from an institution outside of the U.S., final candidates are required to have their degree equivalency verified at www.wes.org or equivalent service. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit.
NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.
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