The Project Manager (PM) will be responsible for a broad range of duties related to planning, organizing, executing, and monitoring the implementation of complex multi-site investigator initiated investigational drug and device studies focused on patients with gastrointestinal conditions.
Duties Include: Independently manage all aspects of study start-up, implementation, and close-out of multiple complex multi-site investigator-initiated investigational drug and device studies. Training and supervising research staff at UNC Training and monitoring research staff at affiliate sites (when applicable) Monitoring and meeting research study milestones (such as recruitment and data collection) Organizing various communications, meetings, conference calls Providing reports to the investigative team Handling research study payments, budgetary documents and invoicing Developing and updating study protocols and standard operating procedures Modifying, maintaining, renewing IRB and other regulatory documentation Interfacing with coordinators and bioinformatics team to monitor enrollment and data quality Providing quality control of data entry procedures and databases, ensuring accuracy and completeness Assisting with grant and manuscript preparation and submission
The role will involve extensive coordination of work and effort and ensuring effective communications within UNC and affiliated sites.
The Lead Investigator will provide overall direction of the project; however, the Project Manager is expected to direct the day-to-day operations and to exercise considerable independent judgment and decision-making to manage the study.
Education and Experience:
Candidates must have a minimum of 3 years of experience in project management of clinical research studies. Extensive knowledge of clinical trials, IRBs, regulatory guidelines, good clinical practices (GCP), and electronic data collection procedures; excellent interpersonal skills and comfortable working collaboratively with high level professionals; ability to train and support site coordinators; highly capable of independent decision-making, multi-tasking, and maintaining orderly study documentations; ability to develop and maintain recruitment and enrollment databases. This position requires excellent organizational and communication skills.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.
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