Director, Oncology Research
105 Carolinas Medical Center
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Benefits offered by this job
Job summary
Advocate Health, based in Charlotte, NC, seeks a senior clinical trials leader to guide the department's strategic direction and drive cross-functional initiatives. The role supports enterprise-wide planning, sponsor communications, and regulatory compliance in a fast-paced research environment.
The position emphasizes project leadership, budget oversight, and continuous improvement across trial operations, with a strong focus on oncology and enterprise strategy alignment.
Qualifications
- Bachelor's Degree required; 15+ years in directly-related clinical trials in pharma/CRO/research center
- Management experience required; oncology experience preferred
- RN not required, but if RN then valid state license and CPR certification; healthcare exp. preferred
Responsibilities
- Provide strategic direction for enterprise-wide clinical trial projects
- Develop and monitor department budgets and resource plans
- Ensure compliance with GCP, ICH, FDA and IRB requirements
- Lead metrics reporting and performance analyses for trials portfolio
- Prepare for sponsor and regulatory audits and inspections
- Present updates to executives on resource, accrual and financial status
Skills
Education
Job description
Department: 80096 Carolinas Medical Center - LC: Clinical Trials: Morehead Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Monday - Friday Full time, days Pay Range: $63.45 - $95.20
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.
- 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.).
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in LCI clinical trials.
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. RN not required, however RNs must hold a current applicable state nursing license and current CPR certification. OR 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. RN not required, however RNs must hold a current applicable state nursing license and current CPR certification. In addition to either of the above, previous experience in a healthcare setting required, especially in a cancer and/or cancer research environment. Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
- Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
- Premium pay such as shift, on call, and more based on a teammate's job
- Incentive pay for select positions
- Opportunity for annual increases based on performance
- Benefits and more 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
Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.
Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits. This is Transformation One shared purpose brought us together. Now, as one of the 10 largest not-for-profit, integrated health systems in the United States, our combined strength and stability drives us forward. Starting with You Caring for nearly 3 million people has inspired a transformation. One in which the patient’s experience guides our vision and empowers us to offer new possibilities in our communities.
What is access? It’s offering more sites of care than any other health system in the Midwest. But there’s a new frontier. Access is exploring the latest technologies to deliver care to patients exactly where they are and exactly when they need it.
With our dynamically inclusive workforce and strong connections to the places where we live and work, we’ll touch more lives and contribute to stronger and more vibrant communities.
We’re redefining the standard for care with world-class doctors and caregivers, innovative solutions, outstanding outcomes, and leading-edge research and clinical trials. Combined, Advocate and Aurora are recognized for clinical excellence in:
- Cardiovascular Care
- Neurosciences
- Gynecology
- Oncology
- Pediatrics
- Primary Care
- Neurology
- Geriatrics
- Trauma Care
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