Safwa Khan
Parsippany
Summary
Dynamic Clinical Research Coordinator with extensive experience at Hackensack Meridian Health, excelling in regulatory compliance and data management. Proven track record of resolving sponsor queries swiftly and enhancing trial workflows through cross-functional collaboration. Adept at ensuring audit readiness and maintaining protocol adherence in high-stakes oncology trials.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator – Phase I Division Oncology
Hackensack Meridian Health – John Theurer Cancer Center
Hackensack
01.2024 - Current
- Organized study documents to support FDA site inspections and ensure audit readiness.
- Collaborated with principal investigators and regulatory teams to resolve protocol changes.
- Coordinated lab tests, radiology exams, and patient appointments per trial protocols.
- Drafted study-specific orders and billing templates to enhance trial workflows.
Lead Clinical Data Coordinator – Phase I Division Oncology
Hackensack Meridian Health – John Theurer Cancer Center
Hackensack
08.2022 - 12.2023
- Entered clinical trial data into EDC systems (Medidata Rave, Veeva Vault, Medrio) with 100% accuracy.
- Resolved over 50 sponsor/CRO queries on safety data and interim analyses within 48 hours.
- Managed biospecimen shipments per study protocols and IATA regulations.
- Collaborated with sponsors such as BMS, Merck, and Pfizer to address supply chain challenges.
Research Coordinator
Cooperman Barnabas Medical Center
Livingston
01.2022 - 07.2022
- Managed IRB submissions, adverse event reports, and training records for over 10 Phase II/III renal transplant trials.
- Screened over 100 patients for eligibility, ensuring comprehensive documentation of informed consent.
Research Assistant
Cooperman Barnabas Medical Center
Livingston
03.2019 - 12.2021
- Managed data entry and patient scheduling for over 12 immunosuppressant trials involving kidney transplant patients.
- Conducted direct patient care, including phlebotomy and vital sign monitoring.
- Ensured medication accountability, adhering to trial protocols and standards.
Education
Bachelor of Science - Biology
Rutgers University
New Brunswick, NJ08.2012
Associate - Biology
Community College of Philadelphia
Philadelphia, PA06.2008
Skills
- Regulatory compliance: ICH-GCP, FDA audits, IRB submissions, CAPA
- Data management: Medidata Rave, Veeva Vault, Medrio, IBM
- Clinical operations: Patient recruitment, protocol adherence, biospecimen handling
- Soft skills: Cross-functional collaboration, detail orientation, HIPAA compliance
Certification
- CITI Program: GCP, IRB, HIPAA
- OSHA Hazmat Certification
- BLS/CPR for Healthcare Providers
References
Available upon request.
Timeline
Clinical Research Coordinator – Phase I Division Oncology
Hackensack Meridian Health – John Theurer Cancer Center
01.2024 - Current
Lead Clinical Data Coordinator – Phase I Division Oncology
Hackensack Meridian Health – John Theurer Cancer Center
08.2022 - 12.2023
Research Coordinator
Cooperman Barnabas Medical Center
01.2022 - 07.2022
Research Assistant
Cooperman Barnabas Medical Center
03.2019 - 12.2021
Bachelor of Science - Biology
Rutgers University
Associate - Biology
Community College of Philadelphia
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