Marianne G Bonner, MSc, BSN, RN
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
OCCUPATIONAL HEALTH NURSING HISTORY
ServeFed Federal, Inc
4539 Metropolitan Court
Suite 202
Frederick, MD 21704
United States Customs House and Federal Building
Federal Occupational Health Unit Room 111
Philadelphia, PA 19106
Occupational Health RN
29 August 2022 to Present
Manage Multi-Agency Occupational Health clinic for Federal Employees
Provide Emergent Care and BLS for major and minor illnesses and injuries
Perform preplacement and annual/ periodic medical workups as required
Services include audiometry and complete vision testing, Tuberculosis testing, Vaccine
administration, collection, preparation and shipment of required blood and urine
specimens and obtaining 12-Lead electrocardiograms
Collaborate with physician in completing medical evaluations
Liaison with multiple federal agencies in coordination and submission of required
Documentation
Provide education to clients focusing on preventive health care and maintaining a health lifestyle
Marianne G Bonner, MSc, BSN, RN
218 Parkview Road
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
CLINICAL RESEARCH WORK HISTORY
Cancer Treatment Centers of America – Philadelphia (Closed permanently)
1331 E Wyoming Avenue
Philadelphia, PA 19124
Oncology Clinical Research RN:
August-2016 to April-2021
SoCRA-certified CCRP
Current WCG and IATA certifications
Coordinates many Phase I, II and III Oncology clinical trials - disease specific and genomic
Primary resource for protocols for investigators, infusion nurses and ancillary staff
Liaison between investigators, primary care providers, institutional review board, sponsor and patients and families
Trains investigators, Infusion nurses and ancillary staff in protocol requirements
Conducts prescreening, subject screening and eligibility process and facilitates management of trial and patient progress throughout the trial and into post-trial survival period
Responsible for data collection and entry, serious adverse event reporting and interacts with monitors to resolve queries and ensure completeness and accuracy of data.
Processes and ships research specimens
Works with Financial staff to ensure proper billing of research procedures
Attends Investigator Meetings and Site Initiation visits
Marianne G Bonner, MSc, BSN, RN
218 Parkview Road
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
CLINICAL RESEARCH HISTORY – Cont’d
Quintiles Transnational, Inc (now IQVIA)
4820 Emperor Blvd
Durham, NC 27703
Clinical Research Associate:
January-2016 to July-2016
Assigned to 15 general therapeutic sponsor-initiated trials with 25+ sites throughout the US Mid-Atlantic region
Performed risk-based monitoring of Phase 2 and 3 protocols focusing on migraine headaches, Alzheimer’s Disease, Pediatric Fibromyalgia, Diabetes Mellitus, Psoriasis, Systemic Lupus Erythematous and Radiologic Axial Spondyloarthritis
Conduct SIV, Interim Monitoring and Close-Out visit
Perform SDV/ SDR on-site
Resolve data queries both on-site and via remote monitoring
Attend Investigator Meetings
Responsible for documentation and reporting of protocol deviations and SAEs to sponsor
Perform in-service education and re-training site staff
Provide site visit reports to investigators and sponsor
Working knowledge of ICH-GCP and Federal regulations
Experienced with MS Office – including Outlook, Word, PowerPoint, Excel
Experienced with CTMS, Inform and REDcap electronic data capture program
Marianne G Bonner, MSc, BSN, RN
218 Parkview Road
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
CLINICAL RESEARCH HISTORY – Cont’d
Thomas Jefferson University Hospital
901 Walnut Street
Philadelphia, PA 19107
Oncology Clinical Research RN
September 2015 – January 2016
Coordinates many Phase I, II and III Oncology clinical trials - disease specific and genomic
Primary resource for protocols for investigators, infusion nurses and ancillary staff
Liaison between investigators, primary care providers, institutional review board, sponsor and patients and families
Trains investigators, Infusion nurses and ancillary staff in protocol requirements
Conducts prescreening, subject screening and eligibility process and facilitates management of trial and patient progress throughout the trial and into post-trial survival period
Responsible for data collection and entry, serious adverse event reporting and interacts with monitors to resolve queries and ensure completeness and accuracy of data.
Marianne G Bonner, MSc, BSN, RN
218 Parkview Road
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
Drexel University College of Medicine
1427 Vine Street
Philadelphia, PA 19106
HIV Clinical Research Coordinator:
March 2013 to December 2015
Coordinated Phase I HIV Vaccine clinical trials
See responsibilities under Fox Chase Cancer Center
Phlebotomy, IV access and ECG administration skills required
Administered investigational product (IP)
Performed advanced cardiac monitoring throughout IP administration
IATA certified – collected, processed, and shipped research specimens
Special Project
Assigned to neglected long-term data collection trial – hundreds of lost subjects – visits t to 6 years out of window
Within a 12-month period
oReactivated over 200 subjects and recruited additional 150+ new subjects
oReturned all active subjects to bi-annual visit schedule
oUpdated study data in REDCap and retrieved lost source documents -- including hundreds of missing signed Informed Consent documents
oAttained inspection-ready status with the creation of an updated and secure filing system
Marianne G Bonner, MSc, BSN, RN
218 Parkview Road
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
CLINICAL RESEARCH HISTORY – Cont’d
Fox Chase Cancer Center
333 Cottman Avenue
Philadelphia, PA 19111
Clinical Research Nurse:
November 2008 to February 2013
SOCRA-certified CCRP
Coordinated Phase I, II and III ITT and sponsor-initiated Head and Neck and Thoracic Oncology clinical trials
Administered Informed Consent to study candidates
Provided continuing monitoring and documentation of participants’ response to therapy pre-, intra- and post-trial
Coordinated all study related visits, treatments and diagnostic procedures with imaging and lab departments, pharmacy, and in-patient units and out-patient infusion centers
Dispensed oral chemotherapy investigational product (IP)
Responsible for reconciliation and accountability of IP
Maintained regulatory documents
Resolved all data queries
Captured and documented all serious adverse events (SAE)
Reported all SAE to IRB, sponsor and, when required, to FDA via MedWatch
Interfaced with IRB, Study Sponsors (incl ECOG) and Regulatory agencies
Working knowledge of FDA regulations, ICH GCP and HIPAA
Activity participated in SIVs, Tumor Board, Service Line meetings and SOP reviews and updates
Represented Fox Chase at Merck Serono Investigator Meeting in Brussels, Belgium
Marianne G Bonner, MSc, BSN, RN
218 Parkview Road
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
Jefferson Health (formerly Aria) Torresdale Hospital
10800 Knights Road
Philadelphia, PA 19114
Interventional Radiology RN:
August 2004 to November 2008
Assisted with Diagnostic and Interventional Radiology procedures
Provided ongoing assessment and monitoring pre-, intra- and post-procedures
Administered Conscious Sedation under the direction of Radiologist
ACLS certified – responded to all emergencies in Radiology Dept
Worked on a full-time and on-call basis covering three separate campuses of Aria Health (Frankford, Torresdale and Bucks)
Covance Periapproval Services, Inc
One Radnor Corporate Center
Radnor, PA 19087
Clinical Research Associate:
September 2001 to August 2004
Managed clinical trial sites throughout US and Ontario, Canada
Ensured that sites were adhering to both protocol and Federal Drug Administration regulatory requirements
Attended pre-trial Investigator Meetings
Responsible for site pre-qualification and study start-up visits as well as ongoing intermittent monitoring and study close-out visits
Reviewed clinical trial data for quality and accuracy before submitting to sponsor
Ensured that protocol deviations were identified and documented and that a Corrective Action plan was created and implemented by the clinical trial site
Provided education to study sites regarding correct study procedures
Submitted reports from each site visit to Covance and Sponsor
Marianne G Bonner, MSc, BSN, RN
218 Parkview Road
Philadelphia, PA 19154-4336
Cell Phone: 215-***-****
***************@***.***
EDUCATIONAL HISTORY:
Drexel University College of Medicine
3141 Chestnut Street
Philadelphia, PA 19104
MSc in Clinical Research Organization and Management 2020 GPA: 3.86
Holy Family University
9801 Frankford Avenue
Philadelphia, PA 19114
BS in Nursing 1983 GPA: 3.31
LICENSE and CERTIFICATIONS:
RN State of Pennsylvania License: RN215529L (exp 31-OCT-2024)
BLS (CPR and AED) Provider (AHA) eCard Code: 205********* (exp 01-AUG-2024)
US MILITARY:
First Lieutenant, US Air Force 07/04/1983 to 05/11/1989 Honorable Discharge
Volunteer Activities:
Weekend Docent at Pennsbury Manor in Morrisville, PA
Conducts tours for visitors at Historic property in Bucks County, PA
Office Volunteer at Caring for Friends in Northeast Philadelphia, PA
Performs data entry, orients new volunteers, acts as receptionist, assists
organizations in scheduling and obtaining food orders,
assists homebound senior citizens in receiving services and
completes special projects
Received Office Volunteer of the Year Award in May-2022