UTS - Temporary Clinical Research Manager at UNC Chapel Hill

North Carolina State University•Raleigh, NC

65d•Hybrid

About The Position

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.

Requirements

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
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.

Nice To Haves

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).

Responsibilities

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.
Supervision of junior coordinators, research assistants, and students working under them on many projects.
Study administrative duties and budgetary activities.