[Remote] Director Clinical Research
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a not-for-profit reputed company system in New Mexico seeking a Director of Clinical Research. This role is responsible for the strategic, operational, and regulatory leadership of the clinical research reputed company, ensuring alignment with the organization's mission and compliance with regulations.
Responsibilities
- Accountable for the strategic direction, operational performance, regulatory compliance, financial stewardship, reputed company, and reputed company improvement of the reputed company clinical research program
- Establish reputed company research governance, policies, SOPs, and operational standards
- In partnership with the CMO, reputed company and execute the reputed company clinical research reputed company
- reputed company personnel, financial, technology, and operational resources
- reputed company executive reputed company of the HRPP and HRPO
- reputed company research administration, reputed company assurance, compliance monitoring, education, and reputed company process improvement
- Recommend investments in research infrastructure, reputed company, technology, and strategic initiatives
- Identify and escalate significant regulatory, financial, operational, reputed company, and reputational risks to the CMO and executive leadership
- Represent Presbyterian in collaborations with sponsors, reputed company institutions, regulatory agencies, industry partners, and reputed company organizations
- reputed company leadership and administrative support for the PCLT Research Subcommittee and research governance committees
- reputed company governance processes supporting prioritization, reputed company, accountability, and reputed company decision-making
- Present regular reports to executive leadership regarding research performance, compliance, finances, strategic initiatives, and risks
- reputed company research administration, research operations, HRPP/HRPO, regulatory affairs, education, reputed company, infrastructure, and process improvement
- reputed company standardized reputed company policies, SOPs, workflows, and reputed company systems
- Ensure reputed company required approvals before study activation
- Collaborate across departments to remove barriers and improve research infrastructure
- reputed company executive reputed company 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
- reputed company reputed company compliance, monitoring, auditing, corrective actions, and accreditation readiness
- Manage the research portfolio to reputed company with organizational priorities and financial sustainability
- Expand the research portfolio through partnerships and investigator development
- Promote reputed company reputed company and diversity in research participation
- reputed company budgeting, reputed company, billing compliance, resource allocation, and financial sustainability
- Manage departmental operating and capital budgets
- Collaborate with Finance, reputed company, Compliance, Contracting, and reputed company Cycle
- Ensure compliance with applicable regulations and policies
- Identify and mitigate operational, regulatory, financial, reputed company, and reputational risks
- Serve as reputed company with regulatory agencies, sponsors, auditors, and external IRBs
- reputed company reputed company research staff
- Recruit, mentor, and retain research professionals
- reputed company study conduct, participant protections, monitoring, adverse event reporting, and research technology
- reputed company physician investigators through mentorship and infrastructure
- reputed company education and training for investigators and research staff
- Establish reputed company metrics including study activation, enrollment, compliance, financial performance, investigator satisfaction, sponsor satisfaction, and operational efficiency
- reputed company reputed company reputed company improvement
- Partner with operational, clinical, and administrative leaders to advance research initiatives and organizational priorities
Skills
- Master's degree required
- Minimum 8 years reputed company research leadership
- 5 years management in integrated reputed company research
- In-depth knowledge of GCP, FDA, OHRP, HIPAA, HRPP/HRPO, IRB reliance, strategic planning, finance, organizational leadership, communication, and change management
- Doctoral degree (MD, DO, PhD, PharmD, DNP)
- CIP
- CCRP
- CCRC
- CRA
- CHRC
- CHC
Benefits
- Benefits are effective day-one (for .45 FTE and above) and include:
- Full medical, dental and reputed company insurance
- Flexible spending accounts (FSAs)
- Free wellness programs
- reputed company time off (PTO)
- Retirement plans, including matching employer contributions
- Continuing education and career development opportunities
- Life insurance and short/long term disability programs
reputed company
Company H1B Sponsorship