Raquel N Neilson
Franklin
Summary
Regulatory professional known for high standards and results-driven approach. Proven ability to navigate complex regulatory environments and implement effective compliance strategies. Committed to fostering team collaboration and adapting to evolving regulatory requirements. Skilled in regulatory research and compliance monitoring, valued for reliability and flexibility.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Research Regulatory Specialist Sr.
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
02.2023 - Current
- Continued supervision, oversight, and mentoring of 3-4 direct reports to assure compliance with deadlines and FDA/IRB regulations
- Managed and participated in a very complex regulatory project to assure compliance with regulations for reporting events and processing urgent submissions in an accurate and timely fashion
- Assisted in streamlining the IBC submission process, working collaboratively with IBC to help institute a written policy for clinical research IBC submissions to allow for single Core submissions for multiple protocols, utilizing the same product, thus cutting submissions timelines by 2-3 months for certain protocol types, and also enhancing regulatory compliance.
- Lead weekly Pod meetings to discuss issues, provide guidance on regulatory requirements, problem solve collectively, continue ongoing education, and team building
- Implemented a team/pod email system to assure no gaps in communication for continued support for both internal and external campus partners.
- Maintain biweekly meetings with Disease Team Managers to aid in transparency for submissions for both regulatory and clinical teams.
- Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents
- Following IRB guidelines, draft and/or modify documents as required by research program activities
- Prepare the required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments and continuing progress reports
- Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission
- Facilitate study start up activities, as necessary, including: submissions to Institutional Biosafety/Radiation Safety Committee, and Institutional Review Boards
- Work closely with Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs associated with each assigned protocol
- Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to supervisor and study investigators
- Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures
- Maintain program timeline including tracking deadlines for program components
Research Regulatory Specialist
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
12.2021 - 01.2022
- Promoted to Disease Team Lead/Pod leader for both BMT and CAR-T protocols
- Mentored and trained/retrained 4 coordinators to assure compliance with FDA regulations, MCW IRB SOPs, and CCCTO SOPs, Guides, and deadline management
- Created an Institutional Biosafety Committee guide working collaboratively with IBC for CCCTO Regulatory staff to utilize
- Maintain and update IBC Submission guidelines as federal regulation interpretations shift/update
- Created/updated regulatory submission guides to assist in the processes to assure accuracy and efficiency
- Provide main administrative support for the preparation of multiple Internal Review Board (IRB) documents
- Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents
- Following IRB guidelines, draft and/or modify documents as required by research program activities
- Prepare the required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments and continuing progress reports
- Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission
- Support faculty to maintain IRB and FDA regulatory files for each IND/IDE and ensure routine monitoring is conducted as required
- Facilitate study start up activities, as necessary, including: submissions to Institutional Biosafety/Radiation Safety Committee, and Institutional Review Boards
- Work closely with Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs associated with each assigned protocol
- Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to supervisor and study investigators
- Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures
- Maintain program timeline including tracking deadlines for program components
- Report program progress to program stakeholders
- Coordinate notifications to all study team members regarding annual regulatory education requirements
- Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program
Regulatory Coordinator
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
11.2020 - 12.2021
- Trained new hires on CPR process and IRB submissions
- Assisted in the updating of several regulatory submission guides to assure relevant, accurate and efficient
- Provide main administrative support for the preparation of multiple Internal Review Board (IRB) documents
- Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent-to-treat documents
- Following IRB guidelines, draft and/or modify documents as required by research program activities
- Prepare the required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments and continuing progress reports
- Review for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission
- Facilitate study start up activities, as necessary, including: Institutional Biosafety/Radiation Safety Committee, and ClinicalTrials.gov postings
- Work closely with Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs associated with each assigned protocol
- Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to supervisor and study investigators
- Assure that the regulatory activities comply with various federal and state laws, and institutional standard operating procedures
- Maintain program timeline including tracking deadlines for program components
- Report program data and progress to program stakeholders
- Coordinate notifications to all study team members regarding annual regulatory education requirements
- Work with Principal Investigator to develop, implement, and maintain comprehensive databases and files related to the program
Clinical Research Coordinator II
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
11.2012 - 11.2020
- Worked alongside several Investigators and assisted in rewriting/amending several Investigator Initiated protocols to better accurately reflect workflow and remain compliant to federal regulations.
- Recruit, screen, enroll and obtain consent from program participants - high enroller.
- Conduct or coordinate training for program participants
- Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants
- Collect, analyze, and disseminate research data
- Report study related data and progress to study investigators
- Work with Principle Investigator to develop, implement, and maintain comprehensive databases and files related to the program
- Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators
- Assure compliance with all relevant IRB and other regulatory agency requirements
- Assist in preparation of IRB documents and reports and study budgets
- Participate on CTO Committees
- Collaborate on the development of clinical research materials including educational materials, marketing materials, websites, forms, and reports
- Maintain patient calendars, screening and enrollment information utilizing the OnCore software tool
- Monitor study related activities on patient and protocol level
- Assist in recruitment and training of CTO staff
- Mentored several CTO staff on prostate protocols.
- Assist in scheduling people and material resources
- Participate in development of standard operating procedures and guidelines
- Process and ship lab specimens as necessary
Clinical Research Coordinator II
Medical College of WI – Urology
03.2008 - 11.2012
- Responsible for Clinical Trials Research Protocols – Phase II - IV studies
- Clinical care including vitals
- Phlebotomy
- Regulatory documentation upkeep and retention per FDA and MCW guidelines
- IRB submissions – all aspects
Clinical Research Coordinator I
Medical College of WI – Urology
11.2003 - 03.2008
- Responsible for developing and implementing a budget protocol for studies which resulted in a profit for the department
- Maintain multiple financial accounts and negotiate new budgets, contracts and sub-contracts for all Urologic studies (Pharma / NIH)
- Responsible for ensuring that all study paperwork is maintained in compliance with FDA and GCP Guidelines
- Provide administrative support for the Clinical Research Team, including the Director of Clinical Research, Clinical Research Nurse Manager and 2 Clinical Research Coordinators
- Coordinate all travel, lodging and program registrations for the research team
- Create and distribute community support group flyers and coordinate their bi-monthly meetings
- Schedule large volumes of both study and non-study related patients and procedures
- Resolve patient issues and seek appropriate avenues to ensure proper workflow
- Coordinate schedules between multiple academic personnel and departments
- Created an IRB approved recruitment flyer and negotiated radio airtime for a large NIH research study while remaining under budget
- Provide administrative support for the Residency Program Director – Dept
- Of Urology
- Support includes scheduling patients, procedures, speaking engagements, visiting professorships, and conferences along with all related travel, lodging, and registration and CV documentation
- Coordinated Grand Rounds CME programs and courses while managing appropriate documents
- Assisted in recruiting quality speakers
- Provided necessary support related to the speakers such as lodging and travel
Administrative Assistant II
Medical College of WI - Kidney Liver Pancreas Transplant
04.2000 - 11.2003
- Provided written and editorial assistance in the preparation of grants, manuscripts, journal publications, abstracts and other study related submissions
- Scheduled surgeries and obtained insurance authorization
- Maintained physician’s CV’s
- Medical transcription for official Rounds notes, letters, operative notes, clinic notes and papers
- Maintained daily calendars, coordinated meetings, social events and conferences
- Coordinated patient consults with physicians and nurse coordinators
- Coordinated travel, lodging and program registrations
- Created Power Point presentations for Transplant Surgeons
Administrative Assistant I
Medical College of WI – Endocrinology via Kelly Services
01.1999 - 01.2000
- Medical transcription
- Processed prescription refill requests
- Coordinated department CME programs
Education
Nursing Assistant -
WCTC
Waukesha, WI02.2006
Nursing school - pre-requisites
MATC
West Allis, WI01.1992
Skills
- CITI Certified
- eBridge Proficiency
- Florence Proficiency
- OnCore Proficiency
- EpicCadence
- EpicCare
- Eclypsis
- Microsoft Office
- Excel
Certification
- GU ASCO Abstract #258, 02/08/18, Shared authorship: Effect of β-hydroxy-β-methylbutyrate (HMB) on muscle strength in older men with prostate cancer (Pca) started on androgen deprivation therapy (ADT): Preliminary results of an open-label, randomized trial. NCT01607879
- Epic Superuser Champion, 09/01/16 -11/01/20, Attend weekly meetings regarding workflow issues or updates to system, Coach staff on working issues without EpicCadence and EpicCare, Assist with New Version training - support logistics and new features.
- Certified, Society of Clinical Research Associates (SOCRA), 04/01/13 - Present
- Institutional Review Board Member (IRB), Medical College of Wisconsin (Committee #3), 07/01/12 - 06/30/14
- Institutional Review Board Member (IRB), Medical College of Wisconsin (Committee #3), 07/01/09 - 06/30/12
- Milwaukee Urologic Society Program Coordinator, 9/1/2004 - 11/01/12, Recruit quality speakers and their representatives, Accounts payable/receivable, Coordinate dinner presentations / acquire appropriate venues, Contract negotiations, Create and distribute meeting flyers, Maintain membership registrar, dues, and meeting attendance.
- Us Too Prostate Cancer Support Group Chapter coordinator, 11/04/04 - 11/01/12
- Nursing Assistant, previously certified in Wisconsin, 2006- Present
Timeline
Research Regulatory Specialist Sr.
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
02.2023 - Current
Research Regulatory Specialist
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
12.2021 - 01.2022
Regulatory Coordinator
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
11.2020 - 12.2021
Clinical Research Coordinator II
Medical College of WI – Cancer Center Clinical Trials Office (CCCTO)
11.2012 - 11.2020
Clinical Research Coordinator II
Medical College of WI – Urology
03.2008 - 11.2012
Clinical Research Coordinator I
Medical College of WI – Urology
11.2003 - 03.2008
Administrative Assistant II
Medical College of WI - Kidney Liver Pancreas Transplant
04.2000 - 11.2003
Administrative Assistant I
Medical College of WI – Endocrinology via Kelly Services
01.1999 - 01.2000
Nursing school - pre-requisites
MATC
- GU ASCO Abstract #258, 02/08/18, Shared authorship: Effect of β-hydroxy-β-methylbutyrate (HMB) on muscle strength in older men with prostate cancer (Pca) started on androgen deprivation therapy (ADT): Preliminary results of an open-label, randomized trial. NCT01607879
- Epic Superuser Champion, 09/01/16 -11/01/20, Attend weekly meetings regarding workflow issues or updates to system, Coach staff on working issues without EpicCadence and EpicCare, Assist with New Version training - support logistics and new features.
- Certified, Society of Clinical Research Associates (SOCRA), 04/01/13 - Present
- Institutional Review Board Member (IRB), Medical College of Wisconsin (Committee #3), 07/01/12 - 06/30/14
- Institutional Review Board Member (IRB), Medical College of Wisconsin (Committee #3), 07/01/09 - 06/30/12
- Milwaukee Urologic Society Program Coordinator, 9/1/2004 - 11/01/12, Recruit quality speakers and their representatives, Accounts payable/receivable, Coordinate dinner presentations / acquire appropriate venues, Contract negotiations, Create and distribute meeting flyers, Maintain membership registrar, dues, and meeting attendance.
- Us Too Prostate Cancer Support Group Chapter coordinator, 11/04/04 - 11/01/12
- Nursing Assistant, previously certified in Wisconsin, 2006- Present
Nursing Assistant -
WCTC
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