Post Award Finance Oncology Manager - Atrium Health - FT
About The Position
Manages multiple projects and ongoing work activities ensuring work plans and deliverables are met. Ensures follow-up on trial subject safety matters as well as regulatory management of trials in their portfolio. Allocates resources appropriately to meet departmental needs. Recruits; interviews; onboards; trains; mentors and coaches; manages performance; works across teams to collaborate on recruitment process. Communicates with teammates and manages remote training/dialogue. Assists with training teammates across enterprise as it relates to a specific trial, project, or process. Coordinates and manages study subjects; educates subjects and families about research studies, treatments, side effects, and follow-up; ensures subject eligibility for participation in clinical trial, ensures timely and accurate data collection and reporting, maintains appropriate documentation on study subjects, as required by the sponsor and standard practices. Assists teammates with start-up, contracting and regulatory process for sponsored projects, develops project-related budgets, tracks project financial performance, time and effort reports, resolution of subject billing issues, and fiscal stewardship of departmental resources. Ensures all aspects of the team's work is accomplished in compliance with accepted Good Clinical Practice (GCP), ICH, OHRP, FDA, corporate and departmental SOPs, and applicable state/federal law. Manages safety of research subjects by oversight of adverse event and safety reporting, as well as internal communications to ensure appropriate clinical follow-up. Prepares and responds to audit findings and coordinates corrective action plans (CAPA). Communicates on-going project status, potential issues, and timelines to investigators, peers and leadership as appropriate. Participates in Institute-wide meetings pertaining to area of responsibility (e.g. Section Meetings, Protocol Review, Tumor Board, clinic-based, etc.). Assists leadership team in seeking ways to reduce costs and improve processes and efficiency. Understands basic scientific methods, biological principles and medical terminology, 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 Boards (IRB), and Human Subjects Protections (OHRP) pertaining to clinical research.
Requirements
- Bachelor's Degree required, health/science preferred.
- Minimum of 3 years clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required; oncology experience strongly preferred.
- Understands basic scientific methods, biological principles and medical terminology, 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 Boards (IRB), and Human Subjects Protections (OHRP) pertaining to clinical research.
Nice To Haves
- Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.
- oncology experience strongly preferred.
Responsibilities
- Manages multiple projects and ongoing work activities ensuring work plans and deliverables are met.
- Ensures follow-up on trial subject safety matters as well as regulatory management of trials in their portfolio.
- Allocates resources appropriately to meet departmental needs.
- Recruits; interviews; onboards; trains; mentors and coaches; manages performance; works across teams to collaborate on recruitment process.
- Communicates with teammates and manages remote training/dialogue.
- Assists with training teammates across enterprise as it relates to a specific trial, project, or process.
- Coordinates and manages study subjects; educates subjects and families about research studies, treatments, side effects, and follow-up; ensures subject eligibility for participation in clinical trial, ensures timely and accurate data collection and reporting, maintains appropriate documentation on study subjects, as required by the sponsor and standard practices.
- Assists teammates with start-up, contracting and regulatory process for sponsored projects, develops project-related budgets, tracks project financial performance, time and effort reports, resolution of subject billing issues, and fiscal stewardship of departmental resources.
- Ensures all aspects of the team's work is accomplished in compliance with accepted Good Clinical Practice (GCP), ICH, OHRP, FDA, corporate and departmental SOPs, and applicable state/federal law.
- Manages safety of research subjects by oversight of adverse event and safety reporting, as well as internal communications to ensure appropriate clinical follow-up.
- Prepares and responds to audit findings and coordinates corrective action plans (CAPA).
- Communicates on-going project status, potential issues, and timelines to investigators, peers and leadership as appropriate.
- Participates in Institute-wide meetings pertaining to area of responsibility (e.g. Section Meetings, Protocol Review, Tumor Board, clinic-based, etc.).
- Assists leadership team in seeking ways to reduce costs and improve processes and efficiency.
- Understands basic scientific methods, biological principles and medical terminology, 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 Boards (IRB), and Human Subjects Protections (OHRP) pertaining to clinical research.
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
- 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
Manager
Number of Employees
1-10 employees
