Director Clinical Research

Presbyterian Healthcare Services

4d•Onsite

About The Position

The Director of Clinical Research is the senior executive responsible for the strategic, operational, and regulatory leadership of the Presbyterian Healthcare Services clinical research enterprise. Reporting to the delivery system Chief Medical Officer (CMO), this position provides executive oversight for all clinical research activities across the organization and serves as the subject matter expert for clinical research. The Director provides strategic leadership by ensuring alignment of research activities with Presbyterian Healthcare Services' mission, vision, strategic priorities, and organizational initiatives. The Director is responsible for the ongoing evaluation, development, monitoring, and continuous improvement of research operations and regulatory processes while ensuring compliance with federal and state regulations governing human subjects research, protection of research participants, and adherence to the highest ethical and quality standards. The Director develops and sustains the infrastructure necessary to support a growing enterprise clinical research program and provides executive oversight of research administration, the Human Research Protection Program (HRPP), the Human Research Protections Office (HRPO), research compliance, financial stewardship, operational performance, and strategic partnerships that expand access to innovative clinical research across Presbyterian Healthcare Services.

Requirements

Minimum 8 years progressive research leadership and 5 years management in integrated healthcare research.
In-depth knowledge of GCP, FDA, OHRP, HIPAA, HRPP/HRPO, IRB reliance, strategic planning, finance, organizational leadership, communication, and change management.

Nice To Haves

Doctoral degree (MD, DO, PhD, PharmD, DNP) preferred.
CIP, CCRP, CCRC, CRA, CHRC, CHC.

Responsibilities

Accountable for the strategic direction, operational performance, regulatory compliance, financial stewardship, quality, and continuous improvement of the enterprise clinical research program.
Establish enterprise research governance, policies, SOPs, and operational standards.
In partnership with the CMO, develop and execute the enterprise clinical research strategy.
Allocate personnel, financial, technology, and operational resources.
Provide executive oversight of the HRPP and HRPO.
Direct research administration, quality assurance, compliance monitoring, education, and continuous process improvement.
Recommend investments in research infrastructure, staffing, technology, and strategic initiatives.
Identify and escalate significant regulatory, financial, operational, legal, and reputational risks to the CMO and executive leadership.
Represent Presbyterian in collaborations with sponsors, academic institutions, regulatory agencies, industry partners, and professional organizations.
Develop infrastructure supporting sustainable research growth.
Expand industry-sponsored, investigator-initiated, federally funded, and collaborative research.
Promote innovation through emerging technologies and AI.
Represent Presbyterian in external collaborations.
Advise the CMO on research priorities, performance, and enterprise risks.
Provide leadership and administrative support for the PCLT Research Subcommittee and research governance committees.
Develop governance processes supporting prioritization, oversight, accountability, and enterprise decision-making.
Present regular reports to executive leadership regarding research performance, compliance, finances, strategic initiatives, and risks.
Direct research administration, research operations, HRPP/HRPO, regulatory affairs, education, quality, infrastructure, and process improvement.
Develop standardized enterprise policies, SOPs, workflows, and quality systems.
Ensure all required approvals before study activation.
Collaborate across departments to remove barriers and improve research infrastructure.
Provide executive oversight of the HRPP and HRPO.
Supervise the HRPO Manager responsible for determinations, reliance agreements, post-approval monitoring, policy development, education, and regulatory compliance.
Ensure compliance with FDA, OHRP, HIPAA, GCP, sponsor, and institutional requirements.
Oversee enterprise compliance, monitoring, auditing, corrective actions, and accreditation readiness.
Manage the research portfolio to align with organizational priorities and financial sustainability.
Expand the research portfolio through partnerships and investigator development.
Promote equitable access and diversity in research participation.
Lead budgeting, contracts, billing compliance, resource allocation, and financial sustainability.
Manage departmental operating and capital budgets.
Collaborate with Finance, Legal, Compliance, Contracting, and Revenue Cycle.
Ensure compliance with applicable regulations and policies.
Identify and mitigate operational, regulatory, financial, legal, and reputational risks.
Serve as liaison with regulatory agencies, sponsors, auditors, and external IRBs.
Lead enterprise research staff.
Recruit, mentor, and retain research professionals.
Oversee study conduct, participant protections, monitoring, adverse event reporting, and research technology.
Develop physician investigators through mentorship and infrastructure.
Provide education and training for investigators and research staff.
Establish enterprise metrics including study activation, enrollment, compliance, financial performance, investigator satisfaction, sponsor satisfaction, and operational efficiency.
Lead continuous quality improvement.
Partner with operational, clinical, and administrative leaders to advance research initiatives and organizational priorities.