Oncology Research Specialist - Regulatory Affairs & Compliance - FT
About The Position
Assists with regulatory and other compliance documentation associated with oncology research projects/clinical trials. Compiles, prepares, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, etc. Participates in the research study start-up activity, working with the PI and others to initiate new research projects within activation timelines. Maintains and assures all assigned study regulatory obligations are managed compliantly in accordance to standard procedures. Maintains documentation for assigned studies in an audit-ready manner and assists in the preparation of site audits and FDA inspections. Serves as study liaison to the IRB. Assists in timely filing of documents and maintains electronic data repositories and other electronic systems. Assists with the development of and maintains process guidelines to ensure procedural compliance Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately. Communicates with research team, sponsors, and IRB on the status of assigned studies. Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within department. Participates in the study project start-up activity, works with the PI and others to initiate new research projects. Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures all documentation is managed compliantly and maintained in an audit-ready manner. Maintains appropriate documentation for assigned studies. Assists in maintenance of filing systems, data repositories and systems. Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately. Obtains required documentation and to assess patient eligibility for research studies. Contacts local research staff to confirm scheduling of tests/treatments required by protocol. Obtains and completes data for patients enrolled on clinical trials.
Requirements
- Must speak/write clearly in English.
- Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding.
- 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 clinical trials.
- High School Diploma or GED required
- Candidate must reside in the Greater Charlotte area due to possible on-site requirements.
Nice To Haves
- bachelor's degree preferred, Health/Science preferred.
- Experience in a healthcare setting preferred, especially cancer care and/or clinical research.
- Certification in clinical research (SoCRA, ACRP, RAPS, etc.) preferred.
Responsibilities
- Assists with regulatory and other compliance documentation associated with oncology research projects/clinical trials.
- Compiles, prepares, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, etc.
- Participates in the research study start-up activity, working with the PI and others to initiate new research projects within activation timelines.
- Maintains and assures all assigned study regulatory obligations are managed compliantly in accordance to standard procedures.
- Maintains documentation for assigned studies in an audit-ready manner and assists in the preparation of site audits and FDA inspections.
- Serves as study liaison to the IRB.
- Assists in timely filing of documents and maintains electronic data repositories and other electronic systems.
- Assists with the development of and maintains process guidelines to ensure procedural compliance
- Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
- Communicates with research team, sponsors, and IRB on the status of assigned studies.
- Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within department.
- Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assures all documentation is managed compliantly and maintained in an audit-ready manner.
- Obtains required documentation and to assess patient eligibility for research studies.
- Contacts local research staff to confirm scheduling of tests/treatments required by protocol.
- Obtains and completes data for patients enrolled on clinical trials.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
1-10 employees
