Director of Clinical Research

Director Of Clinical Research

The Director of Clinical Research provides executive leadership, strategic direction, and operational oversight for all clinical research programs across the organization. This role is responsible for the development, implementation, and growth of a high-quality, compliant, and financially sustainable clinical research program. The Director ensures that all clinical trials and research activities are conducted in accordance with regulatory requirements, ethical standards, and organizational objectives. This role oversees research operations, regulatory compliance, business development, financial performance, and team leadership across multiple sites. The Director serves as the primary liaison with sponsors, regulatory agencies, and institutional leadership, and drives innovation, expansion, and excellence in clinical research.

Essential Duties And Responsibilities

A. Strategic Leadership & Program Development

• Establishes and executes the strategic vision and long-term growth plan for the clinical research program, including expansion of therapeutic areas, study volume, and sponsor partnerships.
• Develops and implements organizational policies, standard operating procedures (SOPs), and infrastructure to support scalable, compliant research operations.
• Identifies and pursues new research opportunities, including industry-sponsored trials, investigator-initiated studies, and grant-funded research.
• Oversees feasibility assessments, site selection, and study portfolio management to align with organizational priorities and capabilities.
• Serves as the organizational subject matter expert on clinical research regulations, trends, and best practices.

B. Operational Oversight & Compliance

• Provides executive oversight of all clinical trial operations, including study start-up, regulatory submissions, patient recruitment, enrollment, conduct, and close-out.
• Ensures compliance with all applicable regulations and standards, including Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and Department of Health and Human Services requirements.
• Oversees Institutional Review Board (IRB) processes, informed consent compliance, and patient safety protocols across all studies.
• Establishes and monitors quality assurance and quality improvement programs, including audit readiness, internal reviews, and corrective action plans.
• Ensures integrity, accuracy, and security of clinical data, biospecimen handling, and documentation systems.
• Collaborates on audits to ensure adherence to research standards and practices.
• Manage and maintain technology systems for research purposes.
• Develop and maintain productive relationships with research sponsors and vendors.

C. Financial & Business Management

• Develops and manages the clinical research budget, ensuring financial performance, cost control, and revenue optimization.
• Oversees contract and budget negotiations with sponsors and Contract Research Organizations (CROs).
• Monitors study profitability, resource allocation, and return on investment across the research portfolio.
• Implements systems (e.g., CTMS) to track financial and operational performance metrics.

D. Team Leadership & Development

• Provides leadership and oversight to Clinical Research Managers, Coordinators, and Assistants across all sites.
• Establishes staffing models, performance expectations, and productivity benchmarks.
• Leads recruitment, onboarding, training, and retention strategies for research personnel.
• Fosters a culture of accountability, collaboration, continuous improvement, and professional development.
• Develops and implements comprehensive education and training programs, including GCP, protocol training, and leadership development.

E. Stakeholder & Sponsor Relations

• Serves as the primary point of contact for sponsors, CROs, regulatory authorities, and external partners.
• Builds and maintains strategic relationships to enhance study opportunities and organizational reputation.
• Represents the organization in sponsor meetings, site visits, audits, and industry events.
• Collaborates with physicians, investigators, and clinical leadership to ensure alignment and engagement in research activities.

F. Clinical Trial Oversight

• Provides high-level oversight of study execution across multiple sites, ensuring adherence to protocols, timelines, and quality standards.
• Guides and supports research teams in complex or high-priority trials.
• Oversees adverse event (AE/SAE) reporting, safety monitoring, and risk mitigation strategies.
• Ensures proper management of investigational products, including drug/device accountability.

G. Communication & Reporting

• Prepares and presents executive-level reports on research performance, including enrollment metrics, financials, compliance, and outcomes.
• Communicates program status, risks, and opportunities to senior leadership.
• Ensures effective communication across interdisciplinary teams and sites.

H. Professional Communication

• Maintains strict confidentiality in all aspects of patient care, research data, and organizational operations in accordance with CCSI Policy and HIPAA.
• Promotes patient-centered communication that reflects empathy, cultural competence, and professionalism.
• Ensures effective collaboration and communication with internal and external stakeholders.

I. Teamwork

• Functions as a key member of the organizational leadership team.
• Promotes interdisciplinary collaboration across clinical, administrative, and research departments.
• Supports organizational initiatives and contributes to overall operational excellence.

J. Professional Development

• Maintains current knowledge of clinical research regulations, trends, and best practices.
• Participates in professional organizations, conferences, and continuing education.
• Leads organizational quality improvement and innovation initiatives related to research.

K. Other Duties

• Performs other duties as assigned.

Education / Qualifications

A. Licensure, Registration, and/or Certification Preferred:

• Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent preferred.
• Clinical licensure (e.g., RN) preferred but not required.

B. Education Required:

• Master's Degree required.
• MD, PhD, APP or equivalent preferred.

C. Experience Required:

• Minimum of 5 years of progressive clinical research experience.
• Minimum of 3 years in a leadership or management role overseeing research teams or programs.
• Experience managing multi-site clinical trials and sponsor relationships strongly preferred.

D. Knowledge, Skills & Abilities:

• Advanced knowledge of GCP, ICH guidelines, FDA regulations, and clinical research compliance.
• Demonstrated leadership, strategic planning, and program development expertise.
• Strong financial acumen, including budgeting and contract negotiation.
• Excellent communication, organizational, and project management skills.
• Ability to manage complex operations, prioritize competing demands, and drive results.
• Proficiency with EMR systems, CTMS platforms, and Microsoft Office Suite.
• Strong knowledge of medical and oncology terminology.
• Ability to build relationships with investigators, sponsors, and regulatory bodies.

E. Physical Requirements and Working Conditions:

• Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist throughout shift.
• Must have functional sight and hearing.
• Ability to function in a latex environment. May be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis; therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary.
• Exposed to a normal office environment.
• Operates all equipment necessary to perform the job.
• Position does require travel among sites and therefore there is exposure to road and weather conditions. Must have a valid driver's license.

Benefits:

• Health insurance
• HSA Option
• Dental insurance
• Paid Time Off (PTO)
• Sick Time
• Vision insurance
• 401(K) 1/ match & profit sharing
• Life Insurance
• Short- & Long-Term Disability