JESSICA DAVIDSON.O.
Dallas, TX ***** 469-***-**** ad2zew@r.postjobfree.com
Professional Summary
Experienced Clinical Research professional, passionate about the field of medicine, research and drug development employing evidence-based approach. Skilled at following Protocol specific guidelines with great attention to detail and exceptional ability to multi-task in Phase I-IV Clinical trials. Adept at collecting, reviewing and verifying original source documents and correctly entering this information in the study specific Electronic Databases in timely manner. Knowledgeable in current FDA/GCP/ICH ALCOA-guidelines, coordinating Study Start up, SIVs and IMVs. Expert at collaborating with cross-functional teams. Possessing a bachelor’s degree in pharmacy and an MPH, ready to bring in a wealth of expertise to this challenging new role. Skills
• ICH/GCP Certified
• Knowledge of Medical, Pharmaceutical&
research terminologies
• Study/ Investigators Coordination & Monitoring
• Understanding of Research Sops &Protocols
• SAE Reporting
• Teachable, with fast assimilating prowess
• Proficient at, but not limited to Epic, iMedidata Rave Edc, CRIO, Microsoft etc.
• Proficient in written and verbal
communications
• Strong organizational skills and attention to
detail
• Great presentation skills
Work History
Clinical Research Coordinator II (Oncology) Apr 2023 - Current UT Southwestern Medical Center Dallas, TX
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Recruited, screened potential study participants, performed intake assessments and informed consent for both therapeutic and observational studies.
• Gathered, processed, and shipped lab specimens following IATA guidelines.
• Coordinated, scheduled, and ensured timely completion of protocol-required events in conjunction with lab staff and other requirements (e.g., pharmacokinetics, scans).
• Acted as a point of reference for study participants and physicians by answering questions and keeping them informed on the study progress.
• Collaborated with the Principal Investigators and other clinical research staff in the preparation and submission of regulatory reports.
Clinical Research Coordinator May 2022 – Apr 2023
Zenos Clinical Research Dallas, TX
• Assisted in preparing and submitting regulatory documents to FDA, IRB and other governing bodies, ensuring compliance with federal, state, and institutional regulations/standards.
• Participated in initiation visits, investigator meetings, regular site research meetings, study- specific on-site meetings and other coordinator meetings, as required.
• Screened patient databases, records, and physician referrals to identify prospective subjects for research studies.
• Diligently documented patient visits and encounters into study specific electronic data capture systems or case report forms (CRFs) within stipulated timelines.
• Trained site research site staff, including new study coordinators, research assistants, pharmacy departments, nurses and lab technicians.
Epidemiologist (Public Health Consultant) Jun 2020 - Apr 2022 Department Of Health and Human Services Texas
• Collaborated with local organizations to expand health services and resources during COVID19 Epidermic, to curtail spread of the virus and other communicable diseases.
• Participated in health promotion campaigns to raise awareness of several health issues.
• Targeted specific community groups with wellness and disease management information.
• Developed and implemented training classes to educate team members and community residents.
• Wrote and lectured informational materials on chronic diseases, substance abuse, and other community health concerns.
Clinical Research Specialist Aug 2016 - May 2020
Pfizer Pharmaceuticals Sandwhich, UK
• Assisted with analysis of research data in collaboration with research department.
• Prepared scholarly manuscripts and final study reports to communicate results of research to broader scientific community.
• Supervised data collection by core research staff.
• Attended and gave seminars under direction of scientific director on several disease states and interventions.
Pharmacovigilance Research Associate Jun 2014 - May 2016 Medicine And Healthcare Regulatory Agency London, Uk
• Conducted literature reviews and synthesized research findings.
• Created strategies for institutions, communities, associations, foundations, governments and people to improve health care and human services systems.
• Designed, constructed and implemented research proposals, protocols and procedures.
• Prepared scholarly manuscripts and final study reports to communicate results of research to broader scientific community.
Education/ Certifications
University of Aberdeen, UK ……. Master of Science: MPH University of Benin, Benin Bachelor of Pharmacy: B.Pharm Clinical Research FastTrack Academy…….ICH/GCP Certificate American Heart Association CPR/AED Certificate UT Southwestern Medical Center IATA Certificate