Neurology Clinical Trials Unit Director

Neurology-411801

Research Professionals

11/29/2023

Yes

Permanent Staff (EHRA NF)

Neurology Clinical Trials Unit Director

EHRA Non-Faculty Research

20060779

NF0007588

Full-Time Permanent

1

40

North Carolina, US

Commensurate with Experience

01/08/2024

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.

OUR VISION
Our vision is to be the nation’s leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.

OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.

Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We will prepare tomorrow’s health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.

Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

The Department of Neurology at the UNC School of Medicine is seeking a dynamic and highly motivated individual to serve as Director of the Neurology Clinical Trials Unit (NCTU). This leader will be responsible for overseeing the planning, execution, and management of clinical trials within the Department of Neurology, with a primary focus on advancing research in the field of Neurology. The Director will work collaboratively with faculty, research staff, sponsors, and industry partners to ensure the success of clinical trials and contribute to the advancement of the clinical research portfolio and provide high-level direction of new and existing clinical research efforts.

Key Responsibilities include:
* Development and implementation of a strategic plan for the Neurology Clinical Trials Unit, aligning research goals with the department’s mission and vision.
* Expanding clinical research at the NCTU by building relationships to amass subjects, addressing marketing and public relations with research sponsors of all types to add clinical projects, ensuring compliance and quality improvement, as well as organizing core resources and staff.
* Oversee all functions of the Clinical Trials Unit, including budgeting, staffing, quality assurance, compliance and resource allocations.
* Ensure the unit adheres to all regulatory requirements and ethical standards.
* Manage contracts, agreements, and relationships with pharmaceutical companies, contract research organizations, federal, and other funding agencies.
* Recruit, train, mentor, and identify resources to train clinical trial staff, including clinical research personnel. Create annual work plan and perform annual performance evaluations for the NCTU members.
* Foster a collaborative and innovative work environment that encourages professional growth and development, thus leading to certification in clinical research.
* Project Management: Coordinate the planning, initiation, execution, and closure of clinical trials, ensuring they are completed on time and within budget.
* Oversee the collection, analysis, and reporting of clinical trial data, ensuring accuracy and compliance with relevant protocols.
* Implement quality control processes to maintain the highest standards in clinical research and ensure the safety and well-being of trial participants.
* Conduct internal audits and provide support for external audits.
* Schedule and preside over biannual NCTU user meetings to foster information dissemination and collect feedback.
* Schedule and preside over bimonthly NCTU policy committee meetings to optimize NCTU workflow and review feasibility of projects.
* Provide feasibility assessment for NCTU clinical pilot award applications and coordinate NCTU pilot award committee meetings.
* Oversee the implementation of new University research policies and procedures within the NCTU. Foster effective communication and collaboration between the NCTU and other departments, faculty, and stakeholders.

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.

• A minimum of 7 years of experience managing clinical research is required.
• Knowledge and experience working in an academic medical institution and supervision of staff are also required.
• Candidate must be able to communicate effectively with various audiences as well as build relationships with a variety of constituents (e.g., industry and government funding representatives, research PIs, study subjects, regulatory personnel, clinical and administrative staff).
• Candidate must demonstrate the capacity to manage multiple responsibilities effectively and exhibit proven management abilities with an understanding of the culture, policies, and procedures relevant to academic research programs.

This position is best fit for an individual with:

• Significant knowledge and experience with academic research, including funding mechanisms and opportunities, identifying research study needs, proposal development, regulatory and IRB compliance policies, and methods of presentation of research results.
• Familiarity with academic research structures and health care organizations.
• Demonstrated relationship-building skills.
• Strong attention to detail with an emphasis on timely and effective communication of complex issues.
• The ability to work simultaneously on several activities and handle multiple demands with efficiency and professionalism.
• Candidates who are Certified Clinical Research Professionals (CCRP) preferred.
• Experience working with Neuro clinical trials.

Not Applicable.