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.
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.
