Program Analyst
Prime Therapeutics
Oncology Research Specialist – Regulatory Affairs & Compliance, Delegation of Responsibility
Advocate Aurora Health
full-time
Posted on:
Location Type: Hybrid
Location: Charlotte • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $25 - $37 per hour
Job Level
Mid-LevelSenior
About the role
- 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.
- 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.
- 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
Requirements
- High School Diploma or GED required; 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.
- Must speak and read/write clearly in English.
- Requires corrected vision and hearing within normal range.
- Must be able to be mobile within the entire healthcare system and other locations that participate in clinical trials.
- Occasionally lifts and carries items weighing up to 35 pounds.
- Primarily works a remote/home-based setting within the Charlotte regional area; required to be in close proximity to the main hospital campus.
- Weekdays, Monday - Friday; standard daytime schedule.
Benefits
- 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
- 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
- Benefits and well-being programs
- Programs that invest in your career development
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchdocumentation managementprotocol amendmentsdata repositoriesclinical trial compliancepatient eligibility assessmentDelegation of Responsibility LogsSignature Profilesprocess guidelinesaudit-ready documentation
Soft skills
communicationorganizational skillsattention to detailproblem-solvingteam collaboration
Certifications
SoCRAACRPRAPS
