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Director of Clinical Research
Director of Clinical ResearchUSSM • Saint Louis, MO, US
Director of Clinical Research

Director of Clinical Research

USSM • Saint Louis, MO, US
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  • [job_card.full_time]
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Job Description

Job Description

Director of Clinical Research

Job Summary

The Director of Clinical Research provides strategic leadership and operational oversight for all clinical research activities at the designated site(s). This role is for the full spectrum of clinic operations at the local level, ensuring seamless integration of research and clinical workflows, optimal resource utilization, and the highest standards of patient care and safety. The Director is responsible for negotiating contracts for new studies, maintaining robust compliance with all regulatory and institutional requirements, and driving business growth through effective sponsor and community engagement. This role fosters a culture of quality, innovation, and collaboration, while ensuring the clinic consistently delivers high-quality data, operational efficiency and regulatory excellence.

Key Responsibilities

Local Clinic Oversight

  • Oversee all day-to-day operations of the clinic, ensuring alignment with organizational goals and regulatory requirements.
  • Provide overall direction and leadership for clinical research operations at the site.
  • Develop and implement strategic plans to expand research capabilities, enhance patient recruitment, and strengthen sponsor partnerships.
  • Collaborate with executive leadership on business development initiatives and long-term growth strategies.
  • Oversee site financial performance, including budgeting, forecasting, and monitoring profitability of research activities.
  • Manages invoicing for all clinical trial services and oversees payments to ancillary services and external vendors to ensure accurate fiscal tracking.

Regulatory & Compliance Oversight

  • Ensure all studies comply with FDA, ICH-GCP, IRB, and institutional guidelines.
  • Establish, maintain, and continuously improve standard operating procedures (SOPs) to ensure consistency and quality.
  • Lead site readiness for sponsor audits and regulatory inspections; oversee corrective and preventive action plans as necessary.

    • Team Leadership & Development

  • Recruit, manage, and mentor a high-performing team of clinical research coordinators, regulatory staff, and support personnel.
  • Set performance goals, provide coaching and professional development, and foster a culture of accountability and excellence.
  • Ensure adequate staffing and resource allocation to support current and anticipated research workload.

    • Study & Patient Operations

  • Oversee feasibility assessments, study start-up, patient recruitment, and study execution across all site protocols.
  • Coordinates all pre-study interactions with sponsors-including qualification, feasibility, and site initiation visits-and directs Clinical Research Coordinators in maintaining ongoing sponsor communication throughout the study lifecycle
  • Ensure patients receive safe, ethical, and compassionate care during research participation.
  • Monitor quality, data integrity, and adherence to study timelines.
  • Serve as an escalation point for complex operational, clinical, or compliance issues.

    • External Relations & Business Development

  • Cultivate strong relationships with investigators, sponsors, CROs, and community partners to drive new study opportunities.
  • Represent the site in sponsor meetings, industry events, and community outreach initiatives.
  • Act as a subject matter expert on research operations and site management in internal and external forums.

    • Required Skills

  • Exceptional leadership, organizational, and strategic planning abilities.
  • Strong financial acumen with experience in budgeting, forecasting, and P&L management.
  • Deep understanding of clinical trial operations, regulatory requirements, and industry best practices.
  • Excellent communication, negotiation, and relationship-building skills.
  • Proven ability to drive growth and operational excellence in a dynamic environment.

    • Education and Experience

  • Bachelor’s degree in Nursing, Life Sciences, Business, or related field required; Master’s degree or MBA preferred.
  • Minimum 7–10 years of progressive experience in clinical research, with at least 3 years in a leadership role.
  • Background that includes evaluating study protocols for operational and scientific feasibility, reviewing or auditing research documentation, and ensuring adherence to FDA and ICH guidelines.
  • Strong track record in site management, regulatory compliance, and sponsor / CRO relationship management.
  • Proven ability to interpret, apply, and operationalize regulatory requirements within a clinical research environment.
  • Certification in clinical research (CCRP, CCRC, CCRA, or equivalent) preferred.

    • Equal Opportunity Employer

    USSM is committed to workforce diversity and are proud to be Equal Opportunity Employers. All qualified applicants will receive consideration without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, sex, gender identity or expression, sexual orientation, or any other basis protected by law.

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