Director Clinical Research (Hybrid)

Presbyterian Healthcare Services; Albuquerque (NM); Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

Retirement plan

Job summary

Presbyterian Healthcare Services seeks a Director of Clinical Research to lead strategic, operational, and regulatory initiatives across the clinical research enterprise. You will report to the Chief Medical Officer and oversee HRPP/HRPO, governance, budgeting, and quality improvements to align research with organizational priorities.

The role requires advanced degrees and extensive experience in healthcare research leadership, compliance, and collaboration with external IRBs, sponsors, CROs,

Qualifications

• Master's or higher in a health, research administration, or related field.
• Experience leading research governance, HRPP/HRPO, and regulatory compliance.
• Evidence of strategic leadership in a healthcare research setting.

Responsibilities

• Provide executive oversight of the enterprise clinical research program.
• Develop and implement governance, SOPs, and quality systems for research operations.
• Lead risk management, regulatory compliance, and partnerships with sponsors and IRBs.

Skills

GCP knowledge

FDA compliance

HRPP/HRPO

IRB reliance

Strategic planning

Financial stewardship

Organizational leadership

Communication

Change management

Education

Master's degree in a related field

Doctoral degree preferred

Job description

Location Address:9521 San Mateo NE Albuquerque, NM 87113-2237Summary: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.• Hybrid: For individuals within 60 miles of Albuquerque, in-office presence is required Tuesday through Thursday.Job Description:Organizational RelationshipsReports To: delivery system Chief Medical Officer (CMO)Direct Reports: HRPO Manager; Research Operations Managers/Supervisors (as applicable); Clinical Research Coordinators and research personnel (as applicable)Key Internal Relationships: CEO, Executive Leadership Team, PCLT, Medical Group Leadership, Hospital Leadership, Clinical Program Leadership, Finance, Legal, Compliance, Revenue Cycle, Pharmacy, Quality, Information Services, Population Health, Physician Investigators, Research StaffKey External Relationships: External IRBs (including WCG), Research Sponsors, CROs, Academic Institutions, Federal and State Regulatory Agencies, Industry Partners, Professional Research OrganizationsAuthority and AccountabilityAccountable 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.Strategic LeadershipIn partnership with the CMO and executive leadership, develop and execute the enterprise clinical research strategy.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.Research GovernanceProvide 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.Research AdministrationDirect 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.Human Research Protection Program (HRPP)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.Research Portfolio ManagementManage 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.Research Finance and Business OperationsLead budgeting, contracts, billing compliance, resource allocation, and financial sustainability.Manage departmental operating and capital budgets.Collaborate with Finance, Legal, Compliance, Contracting, and Revenue Cycle.Regulatory Compliance and Risk ManagementEnsure 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.Research OperationsLead enterprise research staff.Recruit, mentor, and retain research professionals.Oversee study conduct, participant protections, monitoring, adverse event reporting, and research technology.Investigator Development and EducationDevelop physician investigators through mentorship and infrastructure.Provide education and training for investigators and research staff.Performance ImprovementEstablish enterprise metrics including study activation, enrollment, compliance, financial performance, investigator satisfaction, sponsor satisfaction, and operational efficiency.Lead continuous quality improvement.Enterprise CollaborationPartner with operational, clinical, and administrative leaders to advance research initiatives and organizational priorities.Additional Job Description:SkillsIn-depth knowledge of GCP, FDA, OHRP, HIPAA, HRPP/HRPO, IRB reliance, strategic planning, finance, organizational leadership, communication, and change management.EducationMaster's degree required; doctoral degree (MD, DO, PhD, PharmD, DNP) preferred.ExperienceMinimum 8 years progressive research leadership and 5 years management in integrated healthcare research.Preferred CertificationsCIP, CCRP, CCRC, CRA, CHRC, CHC.BenefitsBenefits are effective day-one (for .45 FTE and above) and include:Competitive salariesFull medical, dental and vision insuranceFlexible spending accounts (FSAs)Free wellness programsPaid time off (PTO)Retirement plans, including matching employer contributions Continuing education and career development opportunitiesLife insurance and short/long term disability programsAbout UsPresbyterian Healthcare Services is a locally owned, not-for-profit healthcare system of nine hospitals, a statewide health plan and a growing multi-specialty medical group. Founded in New Mexico in 1908, it is the state's largest private employer with approximately 11,000 employees.Presbyterian's story is really the story of the remarkable people who have chosen to work here. Starting with Reverend Cooper who began our journey in 1908, the hard work of thousands of physicians, employees, board members, and other volunteers brought Presbyterian from a tiny tuberculosis sanatorium to a statewide healthcare system, serving more than 700,000 New Mexicans.We are part of New Mexico's history - and committed to its future. That is why we will continue to work just as hard and care just as deeply to serve New Mexico for years to come.About New MexicoNew Mexico's unique blend of Spanish, Mexican and Native American influences contribute to a culturally rich lifestyle. Add in Albuquerque's International Balloon Fiesta, Los Alamos' nuclear scientists, Roswell's visitors from outer space, and Santa Fe's artists, and you get an eclectic mix of people, places and experiences that make this state great.Cities in New Mexico are continually ranked among the nation's best places to work and live by Forbes magazine, Kiplinger's Personal Finance, and other corporate and government relocation managers like Worldwide ERC.New Mexico offers endless recreational opportunities to explore, and enjoy an active lifestyle. Venture off the beaten path, challenge your body in the elements, or open yourself up to the expansive sky. From hiking, golfing and biking to skiing, snowboarding and boating, it's all available among our beautiful wonders of the west.AA/EOE/VET/DISABLED. PHS is a drug-free and tobacco-free employer with smoke free campuses.