UTS - Temporary Clinical Research Manager at UNC Chapel Hill

Clinical Research Manager

Join the Pack! A community with nearly 8,000 faculty and staff, and 30,000 students. NC State is one of the largest employers in North Carolina, offering a large range of career opportunities.

The department has two overarching goals. The first goal is to increase understanding of how adverse posttraumatic neuropsychiatric sequelae (e.g., posttraumatic stress disorder, pain, depression, and other somatic symptoms) develop after traumatic stress exposure (e.g., motor vehicle collision, military deployment, sexual assault). The second goal is to use this knowledge to develop and test interventions that prevent these outcomes. Our primary strategy to achieve these goals is to recruit and retain outstanding, talented, self-motivated staff, post-doctoral fellows, and faculty who are passionate about improving the lives of individuals who have experienced trauma. The department invites applications for a Clinical Research Manager to help advance this mission.

The Clinical Research Manager will work under the direction of the Director, Managing Director, and Clinical Research Director on a broad range of duties related to planning, organizing, executing, and monitoring the implementation of new and existing trials and research initiatives. Additionally, the Research Manager is responsible for directing daily operations of research study management, and providing input on new research, administrative initiatives, and strategies. They provide supervision and oversight for staff, ensuring compliance with federal, state, and local regulations.

These duties include, but are not limited to, managing all aspects of project start-up, conduct, and close-out, including study design and the development of study procedures, training study team members, coordinating projects, organizing communications and meetings, managing regulatory activities (e.g., IRB submissions, modifications, and renewals), and assisting with grant submissions. This position will be responsible for the supervision of junior coordinators, research assistants, and students working under them on many projects. They will be able to fulfill these duties independently.

Finally, the Research Manager will be responsible for study administrative duties and budgetary activities.

Excellent written and verbal communication skills for internal and external stakeholders (sponsors, CROs, IRBs, investigators).

Comfortable leading meetings and providing study updates.

Communicates feedback constructively and responds professionally under pressure.

Highly organized with ability to manage multiple concurrent studies and competing priorities.

Demonstrates attention to detail, documentation accuracy, and timeliness in deliverables.

Comfortable working autonomously while maintaining team accountability.

Strong ownership mindset - takes responsibility for outcomes and solutions.

Values transparency, teamwork, and proactive problem-solving.

Not suitable for individuals who resist feedback or avoid accountability.

Master's degree and 3-5 years experience managing studies as a whole in a Contract Research Organization.

Must have experience with IND / IDE studies, AE / SAE reporting, and regulatory submissions (IRB, FDA, sponsor).

Experience should include multi-site coordination and academic research settings.

Deep understanding of GCP, ICH, HIPAA, and FDA regulations.

Able to independently draft, review, and maintain SOPs, source documents, and regulatory binders.

Prior experience managing monitor visits, audits, and inspections.

Experienced with electronic data capture (EDC) platforms (e.g., REDCap, Viedoc, Medidata).

NC State University is an equal opportunity employer. All qualified applicants will receive equal opportunities for employment without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex (including pregnancy), sexual orientation, and veteran status. The University encourages all qualified applicants, including protected veterans and individuals with disabilities, to apply. Individuals with disabilities requiring disability-related accommodations in the application and interview process are welcome to contact 919-513-0574 to speak with a representative of the Office of Equal Opportunity.

If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or workatncstate@ncsu.edu.

Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. 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.