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Chapel Hill, North Carolina
Linden, New Jersey
Fort Worth, Texas
Silver Spring, Maryland
Hamilton, New Jersey
Little Rock, Arkansas
Location: Chapel Hill, North Carolina
Type: Full Time
Salary: Dependent on Qualifications
Internal Number: NF0006557
The regulatory team manages the regulatory oversight of LCCC as a clinical trial site and as an investigator-initiated trial (IIT) sponsor. This position contributes to LCCC CR strategic planning efforts to define and provide adequate oversight to LCCC CR in accordance with the regulatory needs of each type of trial (e.g., basic science, diagnostic, health services, prevent, screening, supportive care, and treatment). The individual is responsible for developing, continually re-evaluating, and maintaining stratified risk-based approaches to regulatory oversight. This position also develops tools and leads process improvement initiatives to improve collaborations with clinical teams desiring centralized regulatory support but maintaining decentralized clinical support. It develops integration methods, communication tools, and oversight mechanisms to ensure compliant and streamlined conduct of clinical research in these decentralized clinical units. This position also contributes to LCCC CR strategic planning deliverables related to timely clinical trial activation. This position aids in strategic planning and implementation of expansion of clinical trial offerings within the UNC Hospital System network by providing advice and developing methods to provide regulatory oversight of the network sites.
This position leads relationships with key UNC partners including, but not limited to, the Office of Human Research Ethics (OHRE) Director, Associate Directors and Chairs, and Central IRB Directors (and partner relationship teams).
This position oversees the regulatory program, leading efforts to streamline regulatory maintenance work to create cost efficient models supporting appropriate regulatory oversight without creating unnecessary oversight layers. This position is responsible for optimizing use of clinical trial systems to facilitate regulatory work including, but not limited to, OnCore, Florence, RedCap, and Microsoft Projects. It co-leads efforts to optimize the hand-offs, communications, and interaction with the clinical operations team. The position develops, optimizes, and maintains workload assessment tools, and designs reports to facilitate forward planning for staffing and optimization of resourcing. This position leads discussions of regulatory issues that are considered in the gray without a black and white solution, providing LCCC CR leadership with measured advice citing applicable regulations and weighing the risk of decisions to allow for informed decision-making.
This position leads training of LCCC investigators and staff on regulatory operations/responsibilities. It develops and maintains standard operating procedures (SOPs), work instructions, and templates for regulatory operations.
The Director leads and maintains processes for assessing site-level compliance with applicable regulations. It is responsible for analyzing data from reports (monitoring, auditing, promptly reportable information (PRI)) and identifying areas of risk and in need of targeted process improvement. This position leads process improvement initiatives to ensure continuing compliance and address areas of non-compliance using standard process improvement methods (e.g., root cause analysis (RCA), A3 and Failure Mode and Effects Analysis (FMEA)). This position designs compliance reports about LCCC as a clinical trial site for executive review. This position serves as the primary point of contact for site-level FDA inspections, leading FDA inspection preparation and response efforts
Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.
In depth knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) Guidelines. Experience working in oncology clinical trial research.
At least 1-year prior supervisory experience required. Possess excellent interpersonal skills including leadership, team building, motivation, communication, influencing, decision-making, political/cultural awareness, negotiation, trust building, conflict management and coaching. Possess a broad understanding of psychology, human behavior, organizational behavior, interpersonal relations, and communications. Ability to identify, build, maintain, motivate, lead, and inspire teams to achieve high team performance and to meet the project’s objectives. Ability to create an environment that facilitates teamwork. Comfortable interacting with individuals at all levels of the organization including internal and external to UNC Lineberger. Candidate must enjoy working collaboratively with multidisciplinary groups of colleagues. Excellent customer service skills and good judgement required.
Strong organization and problem-solving skills required. Must enjoy leading a team and be able to direct the efforts of the functional group with minimal oversight from senior leadership. Demonstrated ability leading process improvement initiatives. Demonstrated ability analyzing trends and evaluating data to suggest process improvements. Strong software and computer skills, including MS Office applications required. Demonstrated ability to train and/or teach individuals.
Background in clinical trial site regulatory oversight highly preferred. Master’s degree of public health (MPH), or science (MS), advanced clinical health science degree or life science PhD or law degree (JD) preferred. 3+ years of prior supervisory experience preferred. Lean Six Sigma preferred. Previous experience working for a comprehensive cancer center, preferred. Prior experience with OnCore preferred. Regulatory Affairs Professional Society (RAPS) certification highly preferred. Certified clinical research professional (CCRP) preferred.