Position Summary: The National Director of Clinical Research is responsible for the strategic oversight and day-to-day management of United Derm Partners' clinical research programs across multiple practice locations nationally. This role proactively identifies and pursues new study opportunities for the network, and partners with a Physician Director to provide clinical leadership for the program. This role directs and standardizes clinical trial operations enterprise-wide, working closely with Principal Investigators, UDP Leadership, sponsors, and other stakeholders across all participating practices to ensure every study adheres to protocols, regulations, and standards. The National Director serves as the primary escalation point for study participant safety and well-being across the network and travels regularly to support practices participating in the clinical research program.
Essential Duties and Responsibilities:- Directs and manages activities associated with each clinical research study across all participating UDP practice locations nationally, including study start-up, budget amounts, implementation, and close-outs.
- Builds and standardizes the clinical research program across the enterprise, establishing consistent policies, procedures, and best practices across all participating practices.
- Creates and nurtures collaborations and partnerships with outside affiliate institutions, clinical research organizations, and pharmaceutical partners at a national level.
- Proactively identifies, sources, and pursues new clinical trial and research study opportunities for the network - including outreach to sponsors, CROs, and industry partners - rather than solely evaluating opportunities as they are presented.
- Organizes, plans, and controls workflow of research teams across multiple practice locations and is responsible for ensuring clinical trials are conducted in compliance with federal, state, and institutional guidelines at every site.
- Reviews studies sourced for the network for feasibility and budgets, and obtains approval from the CFO.
- Responsible for the strategic direction and oversight of the clinical research department enterprise-wide.
- Seeks out, recruits, and partners closely with a Physician Director to provide clinical leadership and help guide the strategic direction of the overall clinical research program.
- Responsible for ensuring all PI and sub-PI providers across participating practices understand their compensation for each study, and has full responsibility for tracking payments and how they are applied to each provider by patient across the network.
- Serves as the liaison between principal investigators, sponsors/funding sources, and facilities across all participating practices, overseeing project monitoring and the creation and submission of reports as necessary.
- Responsible for the recruiting, hiring, training, and ongoing oversight of all Clinical Trial Coordinators across participating practice locations.
- Assists Principal Investigators across all sites with study coordination, documentation, and other administrative needs as required to support day-to-day trial conduct.
- Travels to practice locations as needed to support study start-up, site initiation, monitoring visits, audits, and staff training (up to 25% travel).
- Reviews laboratory and clinic procedures and evaluations regularly across all participating sites to ensure protocol compliance.
- Ensures that patient enrollment and research activities comply with established protocols, regulatory and monitoring agency standards, and grant sponsor guidelines at every location.
- Ensures the proper handling, packaging, and shipment of clinical trial specimens and biological materials in accordance with IATA Dangerous Goods Regulations.
- Provides recommendations to proactively address complex issues and/or variances with study-related activities across the network, ensuring consistent management of all administrative and financial functions.
- Ability to understand and maintain discretion and confidentiality related to all aspects of any trial.
- Ability to work with a variety of individuals both inside and outside of the organization, across multiple regions and practice cultures.
- Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants, sponsors, and internal employees enterprise-wide.
- Other duties as assigned.
Education and Experience Requirements:- Minimum 5-7 years of clinical research experience required, including experience managing research programs across multiple sites or practices, preferably in a dermatology environment.
- Prior supervisory or management experience required; experience leading distributed or multi-site teams strongly preferred.
- Experience with EMR systems.
- Bachelor's degree in a health sciences, business, or related field preferred; high school diploma or above required.
- Certified BLS/CPR.
- Certified Clinical Research Coordinator (CCRC) required - issued by the Association of Clinical Research Professionals (ACRP); must be obtained within 12 months of hire if not already held.
- IATA Dangerous Goods Regulations (DGR) certification required for the shipment of infectious substances and biological specimens; must be obtained within 90 days of hire and renewed per IATA's recertification schedule (currently every 24 months).
Knowledge, Skills and Abilities Requirements:- Strong organizational, communication, and leadership skills, with the ability to manage priorities across multiple practice locations and matrixed teams.
- Strong knowledge of industry best practices in medical office operations and multi-site clinical research program management.
- Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research.
- Demonstrated ability to build rapport, navigate sensitive topics, and maintain confidentiality with a diverse pool of research participants and sponsors.
- Skill in exercising initiative, judgment, decision-making, and problem solving in a national, multi-practice environment.
- Detail-oriented and able to handle multiple tasks across multiple locations, following through to completion.
- Ability and willingness to travel up to 25% of the time to support practices participating in the clinical research program.
Supervisory Responsibilities:This position has supervisory responsibilities across clinical research staff at multiple practice locations.
Travel Requirements:This position requires travel of up to 25% of the time to UDP practice locations participating in the clinical research program.
