Director, Oncology Research

Atrium Health Wake Forest Baptist; Charlotte (NC); Sur place; USD 87 000 - 131 000; Plein temps

Avantages offerts par ce poste

Paid Time Off

Health, dental, vision benefits

Flexible Spending Accounts

Adoption assistance and parental leave

Employer-matching retirement plans

Educational Assistance Program

Résumé du poste

Advocate Health seeks a senior clinical trials leader to guide department strategy, define vision, and drive transformational programs across the enterprise.

This role requires extensive GCP/ICH expertise, regulatory acumen, and budget leadership to position clinical trial operations for success within a large health system.

Qualifications

• Bachelor's Degree required; health/science preferred with 15+ years direct clinical trials exp; management exp; oncology exp.
• RN not required; RNs must hold current state nursing license and CPR certification.
• Master's Degree with 10+ years exp in clinical trials; healthcare setting experience; oncology exp; CPR.
• Certification in clinical research (SoCRA CCRP, ACRP, RAPS or similar) preferred.

Responsabilités

• Demonstrates expert knowledge of GCP, ICH Guidelines, FDA, IRB, and OHRP regulations.
• Assists in developing operational budget for the LCI Clinical Trials Department.
• Provides strategic direction and oversight for enterprise-wide trial projects and planning.
• Performs metric analysis to align workloads with objectives.
• Manages Time and Effort reporting to Research Finance.
• Ensures compliance with ICH, GCP and FDA requirements.
• Prepares for sponsor and governmental audits and inspections.
• Delivers updates to executives on resource needs, accruals, financial performance, and investigator performance.
• Develops and monitors trial portfolio performance reports.

Connaissances

GCP knowledge

ICH Guidelines

FDA compliance

Project management

Budget oversight

Regulatory oversight

Data analysis

Executive briefing

Formation

Bachelor's Degree in health/science

Master's Degree (health/science)

Outils

CTMS

Budget tools

Description du poste

Department

80096 Carolinas Medical Center - LC: Clinical Trials: Morehead

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

Job Description Summary

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.

Essential Functions

• 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.).

Physical Requirements

• 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.

Education, Experience And Certifications

• 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.

Our CommitmenttoYou

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.

About Advocate Health

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.

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.