Tamara Gould
Spring Hill
Summary
Clinical research professional with extensive experience at Sanofi-Aventis, specializing in clinical trial management and protocol development. Demonstrated success in data monitoring and compliance, consistently leading teams to exceed project milestones. Skilled in risk assessment and staff mentoring, ensuring high-quality outcomes in complex studies.
Overview
36
36
years of professional experience
1
1
Certification
Work History
Contract Senior Research Associate and Clinical Trial Manager
Rho, Inc.
09.2023 - 07.2024
- Re-monitored closed CNS study at Sponsor's request to ensure data integrity and compliance.
- Monitored CNS/Pain and managed site activities for two studies.
- In addition, performed site monitoring on immunosuppression study and closing depression study.
- Performed all types of visits, including SIVs, IMVs and PSVs.
- Performed multiple closing activities including reconciliation of study files, entry into VEEVA, query resolution, and IP reconciliation and return.
- Executed studies in alignment with GCPs and FDA guidelines to uphold regulatory standards.
- Engaged in weekly Sponsor update calls to ensure alignment on project objectives and timelines.
- Assigned CRAs to sites and mentored them to enhance site performance and compliance.
- Provided risk-based input during monitoring plan development.
Clinical Team Manager II- Monitoring CNS
Syneos Health
09.2022 - 01.2023
- Personally responsible for the management of monitoring expectations and project timelines for two studies.
- Reviewed monitoring reports, mentored assigned CRAs, and provided site initiations and regulatory support to enhance compliance and project oversight.
- Facilitated daily communication with Sponsor and participated in site discussions on recruitment, monitoring issues, protocol deviations, and enrollment challenges to address project needs.
- Developed monitoring guidelines and plans for each study.
- Worked closely with data management to ensure data was monitored on a timely basis.
- Provided risk-based input during monitoring plan development.
- Presented weekly updates to Sponsor on site progression and identified issues to ensure transparency and collaborative problem-solving.
- Worked with CRA line managers to identify training needs and provide feedback on their performance.
Clinical Team Manager – Project Leader
PPD
11.2020 - 12.2021
- Managed clinical resources (CRAs/administrative team) based on ongoing clinical activity projections to ensure optimal resource allocation for timely clinical deliverables.
- Managed the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a trial.
- Provided leadership, coordination and management of the PPD customer joint project team through start up, conduct, tracking, quality, and regulatory compliance management and close-out activities.
- Managed clinical budget; escalated out of scope activities to the appropriate individuals for inclusion in contract modifications.
- Managed contingency planning for data cleaning; clinical data listings, listings review; and coordinated process for reviewing data by clinical team.
- Developed monitoring plan and trained study team on standardized clinical monitoring processes.
- Oversaw development of source documents, CRF/eCRF guidelines, and other project-specific forms for effective study execution.
- Acted as unblinded team leader to monitor temperature excursions and delivery problems with Investigational Product and coordinated replacement shipments.
- Reviewed essential regulatory documents prior to transmittal to the client for release of initial Investigational product.
- Prepared and presented at Investigator Meetings.
- Presented clinical updates weekly to Sponsor.
Senior Clinical Research Associate - Contractor
ResearchPoint Global
01.2011 - 01.2019
- Main monitor for Phase IIB and Phase III project which was consequently FDA approved.
- Conducted field-based and in-house monitoring and site management to ensure compliance with regulatory standards and sponsor requirements.
- Performed site initiations and GCP training.
- Performed data quality control functions including, but not limited to, query management and data audit functions.
- Developed and maintained comprehensive documentation of activities and findings for Research Point and the sponsor.
- Managed daily operations of staff to optimize workflow and support project objectives.
- Collaborated on various clinical trial projects for Mallinckrodt and Stratatech.
- Therapeutic experience with CNS, Full thickness burns (Skin grafting).
Senior Level Clinical Research Associate
PRA Health Sciences
07.2016 - 04.2017
- Conducted field-based monitoring and site management tasks, ensuring compliance with protocol and effective recruitment strategies.
- Identified site issues prior to planned Sponsor audits.
- Facilitated team and sponsor meetings, executing on-site evaluations and site initiations to enhance project alignment.
- Gained expertise in flu vaccine administration to support Phase II clinical trials, contributing to overall study objectives.
Independent Clinical Research Contractor
Gould Clinical Resourcing
03.2010 - 12.2013
- Coordinated clinical trial activities, facilitating communication between stakeholders and optimizing study timelines.
- Supported clinical trial execution by monitoring site performance and addressing issues promptly.
- Icon Clinical Research, Durham, N. Carolina – Senior CRA Contract
- Pharmanet/I3 Research, Tampa Florida – Contract Prompt Monitor – Pfizer Risk Based Remote Monitoring Project
- Managed site operations, ensuring compliance with protocols and regulations.
Manager, Regional Clinical Operations
Sanofi-Aventis, U.S.
Bridgewater
01.2008 - 01.2010
- Executed sponsor clinical trial manager responsibilities for outsourced trial assignments, ensuring compliance with study protocols.
- Provided oversight of monitoring and site performance of studies outsourced to CROs.
- Trained CRO monitors and evaluated performance during co-monitoring visits, enhancing monitoring effectiveness.
- Planned contingencies for potential trial risks to ensure study timelines were achieved.
- Led meetings with vendors to disseminate study updates and account for contracted services.
- Collaborated in development of protocol, case report form, investigator list, and other study documents, ensuring logistical feasibility from a monitoring perspective.
- US Project Manager and monitor for Phase I sleep deprivation trial in 2010 with resulting data base lock two weeks early.
- (Bridgewater, NJ)
Senior Clinical Research Associate
Sanofi-Aventis, U.S.
Bridgewater
01.2005 - 01.2008
- Aligned with Internal Medicine as Lead CRA for in-house managed studies.
- Met enrollment and database lock timelines in large Anxiety and Depression Sleep trial, ensuring timely progression of study.
- Co-led CRA efforts on 3503 Diabetes trial, compiling additional investigators to achieve enrollment targets.
- Trained new associates on clinical research protocols, enhancing team competency in field operations.
- Evaluated physicians in the Northeast area for use as investigators in future trials.
- Monitored compliance with SOPs, GCPs, FDA, and ICH guidelines.
- (Bridgewater, NJ)
Senior Regional Clinical Research Associate
Aventis Pharmaceuticals
Bridgewater
08.2002 - 01.2005
- Served as primary liaison between site and in-house teams for clinical trials in NY region.
- Developed monitoring plans and source verification guidelines for associates during Phase I and Phase IV clinical trials.
- Identified potential investigators and collaborated with field-based education team to enhance subject retention.
- Received On-the-Spot award for exemplary performance as Lead CRA in Diabetes trial.
- (Bridgewater, NJ)
Clinical Research Associate
Novartis Pharmaceutical Services
E. Hanover
01.2001 - 07.2002
- Prescreened investigators, conducted site initiations and EDC training, monitored sites regularly, made recruitment recommendations, and verified compliance with protocol, FDA, and ICH regulations and standard operating procedures to ensure quality and integrity of clinical studies.
- Mentored new research monitors, improving their skills and knowledge to enhance overall team competency and performance.
- Trained novice Study Coordinators and developed source documentation to streamline study processes and ensure regulatory compliance.
- Monitored five protocols simultaneously to ensure compliance with regulatory standards.
- (E. Hanover, NJ)
Clinical Research Associate II
Ingenix International
Morristown
01.1998 - 01.2001
- Served as liaison between sponsor and investigator, facilitating communication and alignment on study objectives.
- Oversaw investigational study sites, conducting on-site quality reviews of case report form data to ensure data integrity.
- Performed routine monitoring visits to verify compliance of investigators and sites with protocol, FDA, and ICH guidelines.
- (Morristown, NJ)
Core Team Member
Tri County Mental Health
Conroe
01.1997 - 01.1998
- Executed on-site emergency patient screenings to assess hospitalization needs, developed treatment plans with defined goals, and advised on medication interventions.
- Coordinated care for mentally ill individuals, facilitated educational groups, and monitored medication effectiveness and adverse reactions.
- Performed initial intakes and managed inpatient unit operations during the day.
- Precepted Associate Degree Nursing Students for North Harris Community College.
- (Conroe, TX)
Case Manager II
CMG Health
Amherst
01.1993 - 01.1997
- Team leader supervising intake coordinators and social workers responsible for authorizing care based on acuity and medical necessity.
- Coordinated with patients and hospitals for pre-certification of inpatient stays and ongoing care management.
- Assisted MDs with denial resolutions, ensuring compliance with contractual terms during start-up and transition for new contacts across five states.
- Educated mental health professionals on effective short-term therapy techniques to enhance patient outcomes.
- Oversaw mental health coverage impacting 300,000 lives.
- (Amherst, NY)
Primary Nurse Private Psychiatric Hospital
Brylin Hospital
Buffalo
01.1989 - 01.1993
- Established treatment plans, assessed lethality risks, and provided short-term daily counseling, medication management, health education, and administrative support as primary nurse.
- Oversaw daily operations and staff assignments for 23-bed unit, ensuring efficient service delivery and quality patient care.
- Facilitated group therapy sessions and served as nursing preceptor for new employees, enhancing team integration and patient support.
- Therapeutic Experience: Mental Health – Schizophrenia, Depression, Eating Disorders, Anxiety, Seizure Disorders, Bipolar Affective Disorders, Shock Treatment, Alzheimer’s, Drug and Alcohol abuse, Adolescent Behavioral and Conduct Issues, ADHD.
- (Buffalo, NY)
Education
B.S. - Nursing
DYouville University
Buffalo, NY01-1987
Skills
- Clinical trial management
- Good clinical practice
- Safety reporting
- Protocol development
- Data monitoring
- Data analysis
- Risk assessment
- Project management
- Team leadership
- Staff mentoring
- Problem solving
- Effective communication
Certification
- Registered Nurse, Florida, current
- Registered Nurse, New York, current
- ACRP Certified Clinical Research Associate, 2002 - 2015
Therapeutic Experience
- CNS, Sleep Maintenance/Phase I, Healthy individuals 18 - 35, Difficult 1 site study with EDC, and 120-page paper CRFs, Sole CRA and Project Mgr.
- Cardiovascular, Lovenox/Phase III B, Adult Post stroke and acute coronary syndrome - 21-80 yrs of age, In hospital studies/ 6 sites, CRA
- Allergies, Phase I/Slow metabolizers of loratadine vs fexofenadine, Healthy Individuals, 1 yr study.100 subjects. Sole monitor., Lead- 2 sites
- Internal Medicine/Pain, Cox Inhibitors/Phase 1 and 11 B, Adult Dx Arthritis, 1 yr. large global study. EDC., CRA
- Endocrine, Phase III B and IV, Pediatric Diabetics Type I, 18-month study 6 sites, CRA
- CNS, Phase III B, Bipolar Adult Population, In hospital study/EDC and Paper-Global study, Co-Lead
- Internal Medicine/Pain and R/A, Rheumatology/Phase III, Pediatric Rheumatoid arthritis, Pain scale monitoring/ EDC large 2-year study, CRA
- CNS/Anxiety and Depression, Phase IV/ Ambien CR, Adult population dx with anxiety/major depression (2 separate studies), Large (46 sites) US very positive study. EDC. Enrollment/data base lock ahead of time., Lead CRA- plus managed 12 other CRAs
- Cardiovascular/Hypertension, Phase III, Adult population with Dx HTN, Global study - EDC, CRA with 10 sites
- CNS/Alzheimer’s, Phase II B, Early onset Alzheimer’s subjects, US study with 50 sites, CRA – 10 sites – successful enrollment
- Vaccines, Phase III, Outpatient Covid Vaccine, Global Study, 40 Sites CTM
- GI, Phase II, Inpatient post anastomosis, US study for small Sponsor, Sr CRA – 6 sites
- Pulmonary, Phase IIB, Pulmonary Hypertension, US study 26 sites, Sr CRA – 8 sites
- CNS, Phase III, Multiple Sclerosis, US study 20 sites, Sr. CRA – 12 sites
- Dermatology, Phase II and III, Full and partial thickness Burn – skin replacement, US study 13 sites, Sr. CRA – 13 sites
- Acute Pain, Phase II B, Post Op Surgery (Bunionectomy), US study 20 Sites, Sr CRA/CTM
- Breast Cancer, Phase II, Breast CA – auditor for sites, US study 6 sites, Sr CRA
- Internal Medicine/RA, Phase III, Adult Rheumatoid Arthritis, US study 10 sites, Sr CRA
Professional Memberships
- ACRP, 1998 - Present
- SOCRA, 2009 - Present
- DIA, 2003 - Present
- Zeta Nu National Honor Society, 1987
Timeline
Contract Senior Research Associate and Clinical Trial Manager
Rho, Inc.
09.2023 - 07.2024
Clinical Team Manager II- Monitoring CNS
Syneos Health
09.2022 - 01.2023
Clinical Team Manager – Project Leader
PPD
11.2020 - 12.2021
Senior Level Clinical Research Associate
PRA Health Sciences
07.2016 - 04.2017
Senior Clinical Research Associate - Contractor
ResearchPoint Global
01.2011 - 01.2019
Independent Clinical Research Contractor
Gould Clinical Resourcing
03.2010 - 12.2013
Manager, Regional Clinical Operations
Sanofi-Aventis, U.S.
01.2008 - 01.2010
Senior Clinical Research Associate
Sanofi-Aventis, U.S.
01.2005 - 01.2008
Senior Regional Clinical Research Associate
Aventis Pharmaceuticals
08.2002 - 01.2005
Clinical Research Associate
Novartis Pharmaceutical Services
01.2001 - 07.2002
Clinical Research Associate II
Ingenix International
01.1998 - 01.2001
Core Team Member
Tri County Mental Health
01.1997 - 01.1998
Case Manager II
CMG Health
01.1993 - 01.1997
Primary Nurse Private Psychiatric Hospital
Brylin Hospital
01.1989 - 01.1993
B.S. - Nursing
DYouville University