Marie Hall
Millstone,USA
Summary
Senior Clinical Research Associate with 16+ years of experience in the field. Consistently meets and exceeds client deliverables throughout all stages of clinical trial conduct, ensuring high-quality outcomes. Highly organized, self-starting, and adaptable to new tools and processes. Metrics-focused professional with strong interpersonal skills. Proficient in ICH-GCP guidelines and various clinical trials applications.
Overview
17
17
years of professional experience
Work History
Senior Clinical Research Associate
Boehringer-Ingelheim
03.2020 - 11.2023
- Responsible for managing sites across multiple therapeutic areas in accordance with ICH/GCP and sponsor guidelines
- Conducted site management activities Qualification, Initiation, Site Training, Interim and Close Out Visits
- Ensure integrity of clinical data and adherence to applicable regulatory, protocol, and sponsor SOPs and study procedures
Senior Clinical Research Associate (Contract)
Precision For Medicine
08.2019 - 02.2020
- Responsible for managing 6 sites on Women’s Health, Pre-Eclampsia Device trial
- Performed risk-based targeted monitoring in addition to on-site monitoring visits
- In addition to typical monitoring oversight responsibilities, conducted patient data logic-checks of eCRF pages in preparation for review by Clinical Team Lead and eventually trial adjudication committee
- Supported investigative sites with data entry and query resolution to meet trial adjudication timelines
Senior Clinical Research Associate
Covance
01.2018 - 07.2019
- Managed 10-12 sites including SWAT team and co-monitoring coverage according to SOP’s and monitoring plan
- Designed and Presented site tracker in excel to oversee all aspects of managing sites including protocol adherence, subject visit projections, regulatory tracking, and site contacts
- Shared and presented tracker for utilization by monitors
- Managed site relationships to meet sponsor data timelines of patient safety while producing overall quality work
- Communicate and oversee feasibility with Principal Investigators for subject enrollment and retention
- Supported and trained for new CRA(s) during on-site monitoring visits
- Projected subject visits to perform source data verification in order to meet data timelines
Senior Clinical Research Associate
PRA/Merck
08.2016 - 01.2018
- Oversaw 8-10 sites in accordance with ICH/GCP and sponsor guidelines
- Included for New Jersey Territory Development, Principal investigator and site recruiting
- Provided support for recruitment, retention, and regional development initiatives
- Mentored new hires as a mentor to provide guidance and assistance in acclimating to their new role
- Conducted site management activities including but not limited to Validation, Initiation, Site Training, Interim and Close Out Visits
- Ensured integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines while adhering to SOPs and study procedures
- Maintained a strong working knowledge of all protocol timelines, data locks, and site query metrics
Clinical Research Associate
Synteract HCR
01.2015 - 08.2016
- Responsible for site management of 15 sites to dedicated pulmonary clinical trial
- Able to build and maintain a solid rapport with study sites and personnel
- Working knowledge of RAVE EDC System
- Responsible for query resolution with site staff to meet data deadlines
- Conduct source data verification and master trial review to ensure site data meets ALCOA standards
- Carried out all aspects of project visit including Site Qualification, Site Initiation, Site Monitoring and Site Close Out visits per sponsor’s timelines
Senior Clinical Research Associate
PharmaNet/i3
03.2014 - 02.2015
- Monitored (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to PharmaNet SOPs and/or client guidelines
- Obtained, reviewed, and processed regulatory and administrative documents from investigative sites
- Ensure investigator adherence to protocol
- Supported investigative sites with query resolution to meet study timelines, database lock, and database freeze
Senior Site Manager
Research Pharmaceutical Services, Inc.
06.2010 - 03.2014
- Mentor to new employees transitioning to the AstraZeneca Project assisting with, but not limited to, protocol related questions and clinical trial applications, observation visits, and administrative support
- Conducted study feasibility and site selection activities
- Assisted with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials
- Ensured the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines while establishing and maintaining a good rapport with study sites
Clinical Research Associate II
PPD
02.2008 - 06.2010
- Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Co-managed, trained, and mentored staff
- Fostered relationships with various clinical vendors according to study needs
Clinical Research Associate I
PRA International
05.2007 - 02.2008
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
- Assessed the qualifications of potential investigative sites, instructed site personnel on the proper conduct of studies, ensured accuracy of data collected, and terminated studies
- Communicated common site trends to Lead CRA and other project team members
Clinical Operations Specialist I
PRA International
07.2006 - 05.2007
- Assigned to a 5-year Oncology study responsible for investigative site monthly monitoring calls for over 45 sites
- Tracked all clinical trial management information in CTMS/Siebel systems and routinely performed study tracking to ensure that the study files are current, accurate, and complete
- Provided clinical status information to team members and project management under guidance of Lead CRA/Clinical Team Lead/LCOS
- Supported Lead CRA/Clinical Team Lead/LCOS/CRA in management of clinical budget and evaluation of study processes
- Evaluated metric data to identify processes
Education
B.A. - Liberal Arts
Rutgers, The State University of New Jersey
Skills
- Clinical Research
- Clinical Trial Conduct
- Quality Results
- Highly Organized
- Self-Starter
- Adaptability
- Metrics Focused
- Interpersonal Skills
- ICH-GCP Guidelines
- Clinical Trials Applications
Affiliations
- CCRA, 05/01/10
- SOCRA, 05/01/10
- NIDA GCP, 02/29/24
- Deputy Commander of Cadet Programs, Civil Air Patrol, Allentown NJ Squadron
Clinicaltrialsystemexperience
Oracle, Veeva Vault, RAVE CTMS, Sponsor specific systems, CRIO, Oracle RDC, Medidata Rave, Medrio, Impact, RedCap, Clinspark, IBM Clinical, DM365, Veeva Vault, Docutrial, Clinergize, BIRDs
Therapeuticexperience - Phases
Healthy Volunteer Trials, Pediatric Allergy to Cow’s Milk-IV, Diabetes & Cardiovascular Death, Stroke, Myocardial Infarction-III, Thrombotic Events associated with Myocardial Infarction-III, Acute Heart Failure-III, Type II Diabetes Mellitus III and II b, Dementia-III, Alzheimer’s Disease II b, Seizures II b, Schizophrenia, Parkinson’s Disease II, Post-Traumatic Stress Disorder II, OCD-II, Focal Segmental Glomerulosclerosis 2, Macular Degeneration II b, Meiobian Gland Dysfunction II, Diabetic Retinopathy-II, Ovarian-II, Breast-III, Prostate-III b, Osteoarthritis of the knee-III, Hormone Replacement-III, Pre-Eclampsia-III, Asthma-IV, Cystic Fibrosis-II b, Bronchiectasis-II b, COVID-19 treatment-II, Post-Transplant HPV-II, COVID-19
Timeline
Senior Clinical Research Associate
Boehringer-Ingelheim
03.2020 - 11.2023
Senior Clinical Research Associate (Contract)
Precision For Medicine
08.2019 - 02.2020
Senior Clinical Research Associate
Covance
01.2018 - 07.2019
Senior Clinical Research Associate
PRA/Merck
08.2016 - 01.2018
Clinical Research Associate
Synteract HCR
01.2015 - 08.2016
Senior Clinical Research Associate
PharmaNet/i3
03.2014 - 02.2015
Senior Site Manager
Research Pharmaceutical Services, Inc.
06.2010 - 03.2014
Clinical Research Associate II
PPD
02.2008 - 06.2010
Clinical Research Associate I
PRA International
05.2007 - 02.2008
Clinical Operations Specialist I
PRA International
07.2006 - 05.2007
B.A. - Liberal Arts
Rutgers, The State University of New Jersey
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