Jackie Gray

Senior-level Clinical Trial Associate with 20+ years of progressive experience supporting Phase I–IV global clinical trials across pharmaceutical, biotech, CRO, and academic environments. Extensive expertise in study start-up, regulatory documentation, Trial Master File (TMF) management, site support, CRO coordination, vendor oversight, financial tracking, and inspection readiness. Strong knowledge of FDA regulations, ICH-GCP, 21 CFR Part 11, IND/NDA processes, and HIPAA compliance.

Recognized for driving operational efficiency, ensuring audit-ready documentation, mentoring junior staff, and supporting cross-functional clinical teams.

Clinical Trials Financial Analyst - Rutgers Cancer Institute of New Jersey

(2025-07 - 2026-01)

• Managed accounts receivable and reconciled clinical trial revenue using OnCore and Oracle systems.
• Performed journal entries and resolved unapplied payments through detailed financial analysis.
• Collaborated with Research Financial Services to support audit readiness and compliance initiatives.

Clinical Research Associate III - Teva Pharmaceuticals

(2020-09 - 2024-04)

• Supported Phase I–IV global clinical trials from initiation through close-out.
• Conducted Site Initiation, Interim Monitoring, and Close-Out Visits.
• Maintained TMF completeness in Veeva Vault eTMF ensuring inspection readiness.
• Managed Investigational Product accountability and reconciliation.
• Reviewed EDC data (Medidata Rave) and resolved queries.
• Supported CRO oversight, vendor coordination, and CT.gov postings.
• Participated in User Acceptance Testing (UAT) for clinical systems.
• Mentored junior CRAs and supported co-monitoring activities.

Senior Clinical Trial Associate - Pacira Pharmaceuticals

(2019-06 - 2019-12)

• Led study start-up activities including feasibility, regulatory document collection, and contract coordination.
• Tracked budgets, purchase requisitions, and study financial metrics.
• Coordinated IRT/IWRS setup and drug supply logistics.
• Ensured TMF quality control and compliance with GCP, ICH, and FDA guidelines.
• Supported SOP revisions and process improvement initiatives.

Regulatory Coordinator (Oncology) - Weill Cornell Medicine

(2019-01 - 2019-06)

• Managed IRB submissions and regulatory documentation for leukemia clinical trials.
• Reported SAEs and ensured subject eligibility compliance.
• Maintained audit-ready regulatory binders and electronic records.
• Trained junior staff on regulatory processes and procedures.

Senior Clinical Trial Associate/ CRA I - Clinilabs, Inc.

(2016-12 - 2018-09)

• Managed study start-up, IRB submissions, and regulatory tracking.
• Maintained CTMS systems and Trial Master Files.
• Reviewed essential regulatory documents (1572s, ICFs, CVs, Financial Disclosures).
• Organized site initiation meetings and assisted with monitoring activities.
• Tracked study timelines and site performance metrics.

Senior Clinical Study Associate - Daiichi Sankyo

(2016-06 - 2016-11)

• Oversaw CRO collection and reconciliation of essential study documents.
• Submitted site-level documents to Document Control Center in support of TMF.
• Reviewed monitoring reports and protocol deviation documentation.
• Tracked study metrics including start-up and recruitment performance.

Clinical Trial Assistant - Bayer HealthCare Pharmaceuticals

(2013-04 - 2016-02)

• Supported Phase I–III trial operations and regulatory submissions.
• Generated Clinical Trial Agreements (CTAs) and supported contract negotiations.
• Processed invoices, managed accruals, and assisted with budget forecasting.
• Maintained and quality-checked Trial Master Files.
• Updated CTMS/IMPACT systems and regulatory tracking databases.
• Supported feasibility processes and executed confidentiality agreements.

Bachelor of Science - Health Science - University of Phoenix