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Title Clinical Research Coordinator
Target Location US-TX-Carrollton
Email Available with paid plan
Phone Available with paid plan
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Dallas, TX Street Address PHONE NUMBER AVAILABLE EMAIL AVAILABLEProfessional SummaryExperienced 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 bachelors 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 verbalcommunications Strong organizational skills and attention todetail Great presentation skillsWork HistoryClinical 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 2023Zenos 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 2020Pfizer 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/ CertificationsUniversity 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

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