Oncology Research Specialist – Regulatory Affairs & Compliance, Delegation of Responsibility

80096 Carolinas Medical Center - LC: Clinical Trials: Morehead

Full time

Yes

40

• Assists with Regulatory and other compliance documentation associated with oncology research projects/clinical trials.
• Participates in the study start-up and maintenance activities, working with the PI and others on the delegation of research study related tasks.
• Completes and maintains Delegation of Responsibility Logs, Delegation of Tasks Log and Signature Profiles for oncology research studies.
• Assures study delegation of responsibility documentation is managed compliantly and maintained in an audit-ready manner.
• Maintains appropriate documentation for assigned studies in accordance to standard procedures.
• 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.
• Primarily works a remote/home-based setting within the Charlotte regional area.

Pay Range

$24.85 - $37.30

This position will be remote with occasional onsite time, M-F, 8am-5pm. Candidate must live within commuting distance to Charlotte.

Essential Functions

• 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.

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 clinical trials.

Education, Experience and Certifications

High School Diploma or GED required; bachelor's degree strongly 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.

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