Director, Oncology Research

Advocate Health and Hospitals Corporation • Charlotte, NC

6d • Onsite

About The Position

A senior member of the clinical trials leadership team that provides strategic direction, develops and communicates vision for the department, shares expertise across multiple discipline, creates an environment of continuous improvement by defining business needs and driving transformational change, sponsors and leads innovative projects and uses project management methodologies to position LCI for success, helps develop and lead enterprise strategy through programmatic, geographic, technical and operational assessments and planning.

Requirements

• Bachelor's Degree required, health/science preferred with minimum of 15 years of directly-related clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required; management experience required; oncology experience required.
• Master's Degree with at least 10 years of directly-related clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required; management experience required; oncology experience required.
• previous experience in a healthcare setting required, especially in a cancer and/or cancer research environment.

Nice To Haves

• RN not required, however RNs must hold a current applicable state nursing license and current CPR certification.
• Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.

Responsibilities

• Demonstrates expert knowledge of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines, as well as applicable rules/regulations pertaining to research.
• Knowledge of regulatory requirements of the Food and Drug Administration (FDA), Institutional Review Board (IRB), and Office of Human Subjects Protections (OHRP) pertaining to clinical research.
• Assists in developing the operational budget for the LCI Clinical Trials Department
• Provides strategic direction and oversight for clinical trial projects which are enterprise-wide and assists with strategic planning for both the enterprise-wide growth of clinical trials and associated operations.
• Performs metric analysis to ensure research workload for clinical trial operations meets the overall research team objectives.
• Responsible for comprehensive Time and Effort reporting requirements to Research Finance ensuring research time is allocated appropriately.
• Ensures all clinical trial operations are in compliance with ICH, GCP and FDA requirements.
• Ensures appropriate documentation is maintained to meet applicable federal regulatory requirements as well as trial sponsor requirements.
• Ensures the department is prepared for sponsor and governmental audits and inspections.
• Provides updates to executive stakeholders on current/forecasted resource requirements, accrual status, financial performance, investigator performance, etc. through formal presentations and reports.
• Develops and monitors performance reports related to the trials portfolio (includes sponsor and CRO reports, corporate financial performance, corporate HR reports, CTMS-based reports, key performance indicators, etc.).

Benefits

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior