Cathy Gallant
Tamarac,FL
Summary
Knowledgeable Clinical Research Associate with several years of experience in monitoring and assisting in oncology clinical trials. Clear, concise and effective written communication abilities. Lead Site Manager on 2 High Priority trials, one resulting in Breakthrough designation, the second currently ongoing. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed. 20+ years experience as oncology nurse.
Overview
32
32
years of professional experience
Work History
Specialist Site Manager
Johnson & Johnson
Tamarac, FL
10.2023 - Current
- Lead Site Manager on Paloma-3 study
- Attend Local Trial Manager/Central Trial Manager Meetings
- Assist Local Trial Managers with various study tasks as needed
- Conduct Site Manager Meetings Biweekly providing study updates, expectations and deliverables, provide refreshers for company processes as needed
- Primary resource to Site Manager for protocol/ Site Management activity related questions
- Mentor/trainer to new employees
- RAVE subject matter expert
- Provide support to site managers and Local Trial Managers
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Participated in internal audits related to clinical research operations processes.
Senior Site Manager
Johnson & Johnson
Tamarac, Florida
06.2021 - 10.2023
- Lead Site Manager meeting for study updates and expectations of study
- Lead Site Manage for Both Chrysalis and Paloma-3 studies
- Work Closely with Local Trial Managers
- Study Startup activities
- Mentor/ trainer for newly hired Site Managers
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
- Prepared reports summarizing study progress and results for senior management review.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.
- Participated in internal audits related to clinical research operations processes.
- Maintained strict confidentiality to keep personal information and collected data private.
- Participated in educational training, activities and professional development programs.
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Performed pre-study, closeout and interim visits to check on study activities.
- Evaluated proof of eligibility and consent for participants.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
Clinical Research Associate III
PRA Health Sciences Inc.
Tamarac, FL
07.2019 - 06.2021
- Participates in educational training, activities and professional development
- Adheres to good clinical practices, operating procedures and regulatory requirements
- Performs pre-study, closeout and interim visits to check on study activities
- Establishes and updates site monitoring schedule and serves as project head for investigational sites
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
- Provides regular site status information to team members, trial management, and updates trial management tools
- Completes monitoring activity documents according to monitoring guidelines
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Escalates site and trial related issues, until identified issues are resolved or closed
- Performs essential document site file reconciliation
- Performs source document verification and query resolution
- Assesses IP accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
- Communicates with investigative sites
- Ensures all required training is completed and documented
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timeline
- Functions independently with minimal oversight required
- May be assigned to complex studies and/or sites
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities
- Supported investigator selection and qualification process by offering professional input
- Assessed drug storage conditions and procedures to check adherence to standard protocols.
Clinical Research Associate II
PRA Health
Tamarac, FL
11.2016 - 07.2019
- Conducted all activities according to defined project-specific quality and performance standards
- Monitored site activities and sent follow-up letters to participants
- Evaluated proof of eligibility and consent for participants
- Checked electronic data capturing systems for integrity and compliance
- Performed pre-study, closeout and interim visits to check on study activities
- Achieved project-specific quality and performance standards and provided documentation and communication
- Participated in educational training, activities and professional development programs
- Adhered to good clinical practices, operating procedures and regulatory requirements
- Assessed drug storage conditions and procedures to check adherence to standard protocols
- Reviewed the site regulatory binder to check collection procedures and completeness of paperwork
- Established and updated site monitoring schedule
- Attended meetings and reported on activities and resolutions
- Maintained strict confidentiality to ensure privacy of personal information and data collected
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation
- Supported investigator selection and qualification process by offering professional input
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities
- Achieved project objectives by working closely with teammates.
Senior Clinical Research Associate
PPD
Gray, ME
04.2016 - 11.2016
- Served as the primary contact with individual investigative sites that conduct clinical research
- Tracked enrollment status reports to ensure study stays on track to meet enrollment goals
- Served as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues
- Served as an approved accompanier, conduct sign-off authorization visits for new CRAs on pre-study, initiation, interim and close-out visits
- Performed Serious Adverse Event reconciliation and work with sponsor, study sites and CRAs to resolve discrepancies
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits
- Reviewed the site regulatory binder to check collection procedures and completeness of paperwork
- Adhered to good clinical practices, operating procedures and regulatory requirements
- Assessed drug storage conditions and procedures to check adherence to standard protocols
- Attended meetings and reported on activities and resolutions.
Clinical Research Associate
PPD
Gray, ME
11.2014 - 04.2016
- Served as the primary contact with individual investigative sites that conduct clinical research
- Tracked enrollment status reports to ensure study stays on track to meet enrollment goals
- Performed Serious Adverse Event reconciliation and work with sponsor, study sites and CRAs to resolve discrepancies
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits
- Reviewed the site regulatory binder to check collection procedures and completeness of paperwork
- Adhered to good clinical practices, operating procedures and regulatory requirements
- Assessed drug storage conditions and procedures to check adherence to standard protocols
- Attended meetings and reported on activities and resolutions.
Clinical Research Associate I-II
Quintiles
Gray, ME
07.2013 - 11.2014
- Main contact for sites, performed site visits from selection to close-out, evaluated and ensured patient safety, data quality, adherence to the protocol and agreed SOPs
- Complied with overall study timelines to maintain recruitment progress, data cleaning and appropriate IMP management
- Created, distributed and maintained all relevant study documentation
- Coordinated 5 phase II-IV clinical trials in various Oncology, renal and dermatology indications
- Conducted site visits to determine protocol and regulatory compliance, and prepared required documentation
- 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.
Clinical Research Coordinator
Mercy Hospital
Portland, ME
09.2006 - 07.2013
- Managed all aspects of coordination in multiple Oncology studies with a concentration on Breast Cancer, and Lung Cancer
- Screened subjects, obtained informed consent, entered, and managed patients in Oncology Clinical trials
- Detailed in documentation with strict adherence to ICH-GCP standards
- Performed study start up tasks including: contract and budget negotiation and regulatory submissions
- Worked with a variety of different Electronic Data Collection systems, including RAVE and InForm
- Interpreted and implemented requirements as set forth in protocols.
Oncology Nurse
Maine Center for Cancer Medicine
Portland, ME
03.1992 - 09.2006
- Triaged patient's calls and managed side effects of chemotherapy
- Started peripheral IV and central line venous access for chemotherapy, antibiotic and blood transfusion administration
- Communicated and collaborated with team members on all levels of the Oncology care continuum.
Education
B.S in Nursing -
University of Southern Maine
01.1989
Skills
- Windows XP
- MS Word
- PowerPoint
- MS Excel
- CTMS
- EDC (RAVE, Inform)
- Regulatory compliance
- Patient Safety
- Site management
- Monitoring visits
- Clinical documentation
- IP Accountability
- Problem solving
- Detailed documentation
- Oncology expertise
- Trip reports
- Patient recruitment strategies
Additional Information - Licenses Certifications
- Registered Nursing License, State of Maine, Aug 1989
- Oncology Nursing Certification, 1995
- Barnett Accreditation-Expert GCP Exam for Managers and Staff interacting with investigational sites- 2014
- ACRP-CCRA Sep 2019
Activities
- Member of the Association of Clinical Research Professionals since 2012
- Member of the Oncology Nursing Society since 1992
- Member of the Society Broward Chapter Oncology Nursing Society since 2018
Timeline
Specialist Site Manager
Johnson & Johnson
10.2023 - Current
Senior Site Manager
Johnson & Johnson
06.2021 - 10.2023
Clinical Research Associate III
PRA Health Sciences Inc.
07.2019 - 06.2021
Clinical Research Associate II
PRA Health
11.2016 - 07.2019
Senior Clinical Research Associate
PPD
04.2016 - 11.2016
Clinical Research Associate
PPD
11.2014 - 04.2016
Clinical Research Associate I-II
Quintiles
07.2013 - 11.2014
Clinical Research Coordinator
Mercy Hospital
09.2006 - 07.2013
Oncology Nurse
Maine Center for Cancer Medicine
03.1992 - 09.2006
B.S in Nursing -
University of Southern Maine
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