Coordinator - Oncology Research Regulatory Affairs & Compliance

Job Summary

Coordinates the clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted, follows industry standards and applicable regulations including FDA/OHRP guidance, GCP and ICH.

Essential Functions
Fulfills the job responsibilities of the Oncology Research Specialist – Regulatory Affairs & Compliance, and:

• Provides regulatory submissions and manages regulatory documentation for clinical trial start-up, consent and/or protocol amendments, continuing review, closure to accrual, safety reporting, suspension, study termination and other information to reporting agencies and trial sponsors.
• Liaise with Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/CRO and other internal/external entities on clinical trial regulatory operations.
• Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required.
• Oversees timely regulatory submissions to meet project deadlines.
• Coordinates and prepares for audits with appropriate departments to address regulatory-related quality and compliance matters.
• Participates in sponsor study start-up and follow-up meetings as appropriate.
• Collaborates and ensures procedural compliance related to study conduct.
• Assists in the development, improvement, and review of Standard Operating Procedures and guidelines to ensure procedural compliance.
• Provides regulatory-related educational and technical assistance to research staff including orientation and mentoring of new research teammates.

Physical Requirements

Primarily works in remote/home-based setting in the Charlotte regional area.
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 and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred. Regulatory knowledge of FDA/OHRP regulations, and more complex regulatory processes.

Pay Range

Our Commitment to You:

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