Jeannette Woodworth
Adkins,TX
Summary
Dynamic clinical research leader with extensive experience at Texas Dermatology And Laser Specialists, driving innovation in trial management and data collection. Successfully managed complex clinical trials, ensuring compliance and optimizing processes. Valued for collaborative approach and results-driven mindset, with strong analytical and regulatory skills. Excellent in patient recruitment and safety, utilizing critical thinking and adaptability to enhance participant retention and safety. Proven track record in collaborating with major pharmaceutical companies to deliver high-quality research outcomes.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Director of Clinical Research
Texas Dermatology And Laser Specialists
11.2018 - Current
- Introduced new technologies in clinical research, such as e-source and e-regulatory, driving improvements in speed and quality of data collection and analysis methods.
- Contributed to the development of organizational policies related to clinical research, ensuring alignment with industry best practices.
- Communicated with all providers on a regular basis, sharing knowledge of new studies starting and in the near future for the purpose of translating the information to possible candidates for studies.
- Ensured all training programs for staff involved in conducting clinical trials stayed current, whether general or study specific.
- Completed regulatory submissions for new studies, providing correct and current information to ensure timely approval of study for site.
- Oversaw and participated in recruitment efforts for clinical trials, developing strategies to target diverse patient populations that met strict inclusion criteria.
- Led efforts to maintain a strong quality assurance program, conducting regular audits and implementing corrective measures as needed.
- Worked side by side with each staff member to set clear, concise goals and monitored productivity and output for research personnel.
- Enhanced patient safety by rigorously monitoring adverse events and promptly addressing any concerns.
- Negotiated contracts with vendors, such as radiology, ophthalmology, and audiology, ensuring timely delivery of services at competitive prices while maintaining high-quality standards.
- Recruited, hired and trained all staff, providing direct supervision and ongoing learning.
- Discussed medical histories with patients in effort to provide most updated information for study.
- Scheduled site yearly calibration of all equipment and maintained monthly site temperature logs for all areas.
- Negotiated complex budgets for multiple concurrent studies, optimizing resource allocation to maximize yearly return.
- Secured prompt SIV dates to expedite start up and had entire team participate in the meeting to learn all study details.
Clinical Research Coordinator
Texas Dermatology And Laser Specialists
07.2015 - 11.2018
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Followed informed consent processes and maintained records.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
Clinical Research Coordinator
Texas Liver Institute
11.2012 - 07.2015
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed and maintained accurate and up-to-date case report forms and source documents.
Clinical Research Coordinator
Sylvana Research
02.2003 - 10.2012
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Followed informed consent processes and maintained records.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
Education
Licensed Vocational Nursing - Nursing
St. Philip's College
San Antonio, TX02-2003
Skills
- Clinical trial management with many large scale pharmaceutical companies, eg Eli Lilly, Abbvie, Galderma, Gilead, Janssen, Leo, Amgen, BMS, Novartis, Merck, Regeneron, and Takeda as well as CRO's ICON, Parexel, Innovaderm, and Proinnovera
- Clinical data management in several CTMS and EDC systems eg Realtime, Veeva, Florence, Medidata,
- Site selection process via tour of facility and displaying all the staff abilities and cetifications
- Therapeutic area expertise in Allergy, Immunology, Pulmonology, Dermatology, Vaccines, Hepatology, Gastroenterology, Rare Diseases, Metabolic Disorders
- Teamwork at the forefront of each day jumping in and doing anything possible to make all visits run efficiently whether its rooming a patient, vitals, blood draw, processing or recruiting
- Critical thinking to help solve problems in the moment
- Adaptability and flexibility to patient needs and schedules as well as staff needs
Certification
- Vocational Nursing License - 2003- current
Timeline
Director of Clinical Research
Texas Dermatology And Laser Specialists
11.2018 - Current
Clinical Research Coordinator
Texas Dermatology And Laser Specialists
07.2015 - 11.2018
Clinical Research Coordinator
Texas Liver Institute
11.2012 - 07.2015
Clinical Research Coordinator
Sylvana Research
02.2003 - 10.2012
Licensed Vocational Nursing - Nursing
St. Philip's College
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