Jennifer M. Roye
Clinical Research
Sterling Heights,Michigan
Summary
A results-driven professional with extensive experience in oncology nursing, clinical trials, and program management. Proven expertise in organizing, overseeing, and executing clinical studies, with a focus on ensuring regulatory compliance and maintaining high data integrity. Skilled in managing site relationships, supporting protocol adherence, and ensuring successful trial outcomes within clinical trials and pharmaceutical research. Adept at developing and maintaining study documentation, identifying and resolving obstacles to enrollment, and conducting quality assurance to verify data quality. Strong background in training and mentoring teams, promoting professional growth, and fostering collaboration to enhance clinical trial performance. Passionate about advancing medical technology development and improving patient outcomes through strategic leadership, attention to detail, and a commitment to excellence in clinical research.
Overview
25
25
years of professional experience
3
3
Certifications
Work History
Clinical Research Administrative Nurse Manager
Corewell Health
04.2012 - 10.2024
- Directed up to 25 staff in pharmaceutical, NCTN, and IIR.
- Enhanced team performance by conducting regular performance evaluations and mentoring staff.
- Oversaw screening, recruitment, enrollment, follow-up, and pre-study preparations for Phase II and III oncology clinical trials.
- Led recruiting and hiring, managed the employee review process, and ensured compliance with local, state, and federal regulations while maintaining elevated staff morale and professionalism.
- Managed and achieved favorable budgets, including contributing to study budget negotiations.
- Coordinated review and revision of departmental standards of practice and new staff orientation.
- Closely monitored and maintained departmental quality assurance, resulting in acceptable audits.
- Conducted quality assurance audits to maintain high standards of compliance with GCP, ICH, and other relevant regulations to ensure inspection readiness throughout the study life cycle.
- Successfully prepared, submitted, and secured awards for multiple national and federal research grants, demonstrating expertise in grant writing, compliance, and funding acquisition.
- Actively collaborated with stakeholders to align regional deliverables with overall study goals, providing regular study updates.
- Managed study timelines, from feasibility through closeout, ensuring operational feasibility and timely submission of regulatory documents.
Assistant Nurse Manager
Beaumont Health
11.2011 - 04.2012
- Led five staff in pharmaceutical and cooperative group research.
- Assisted the entire department in achieving increased operational efficiency, conducting ongoing quality assurance, expanding educational opportunities, and promoting process improvement and audit readiness.
- Performed real-time chart audits for patients ensuring accuracy and completeness of information while capitalizing on opportunities for process improvement.
- Managed protocol and patient eligibility review
- Assisted in developing a favorable budget for commercial studies.
Research Nurse Clinician
Beaumont Health
04.2003 - 11.2011
- Coordinated recruitment, eligibility, enrollment, and follow-up of patients to cancer surveillance, prevention, and treatment clinical trial protocols.
- Maintained requirements of research protocols, including proper documentation and patient teaching.
- Reduced protocol deviations by providing thorough training on study procedures to staff members.
Hematology / Oncology Staff and Charge Nurse
Beaumont Health
06.1999 - 04.2003
- Coordinated care of patients on the hematology and oncology floor
- Provided direct nursing care to hematology and oncology patients
- Administered medications, including chemotherapy and blood product transfusions
- Provided support to colleagues, enhancing overall productivity.
- Assisted team in daily operations to ensure smooth workflow.
Education
Bachelor of Science - Nursing
Oakland University
Rochester, MISkills
Clinical Research
Good Clinical Practice (GCP)
Regulatory Compliance
Data Quality & Integrity
Site Management
Problem-Solving
Attention to Detail
Microsoft Office Suite Proficiency
Affiliations
- NCTN Groups: Southwest Oncology Group, National Surgical Adjuvant Breast and Bowel Project, Gynecologic Oncology Group, Suncoast / H.L. Moffitt Cancer Research Base, Radiation Therapy Oncology Group, NRG Oncology, Alliance, Wake Forest, ECOG-ACRIN
- Research Groups: Society of Clinical Research Associates, Oncology Nursing Society
- Clinical Research Partners: AstraZeneca, Merck, Natera, Gilead Sciences, NSABP Foundation, Alliance Foundation Trials
Abstracts Publications And Presentations
- Abstract, Representation of Minorities and the Elderly in Cancer Clinical Trials at a Single Institution - The William Beaumont Hospital Experience, Journal of Cancer Epidemiology and Prevention, Dr. Mohammed Ibrahim
- Publication, Representation of Minorities and Elderly in Cancer Clinical Trials at a Single Institution-The William Beaumont Hospital Experience, Journal of Cancer Epidemiology and Prevention, 01/01/17, 2, 1, 1
- Presentation, A Fruitful Partnership in Metro Detroit: The Implementation of a Behavior Modification Workshop in Minority Communities, 143rd APHA Annual Meeting and Expo, 11/01/15
Certification
- State of Michigan Nursing License #4704220710
- Society of Clinical Research Professionals Certification (CCRP)
- Basic Life Support (BLS) Certification
- Good Clinical Practice (GCP) Certification
Timeline
Clinical Research Administrative Nurse Manager
Corewell Health
04.2012 - 10.2024
Assistant Nurse Manager
Beaumont Health
11.2011 - 04.2012
Research Nurse Clinician
Beaumont Health
04.2003 - 11.2011
Hematology / Oncology Staff and Charge Nurse
Beaumont Health
06.1999 - 04.2003
Bachelor of Science - Nursing
Oakland University
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