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- www.linkedin.com/in/Jessicabeardseniorcra
Certified Clinical Research Professional with over 23 years of experience in protocol management, employee onboarding and supervision, UAT and general trial oversight. UAT contributor committed to confirming proper functionality and usability of software before release. Expertise in software design review offering input on functional requirements and potential problems. Reviews software documentation to verify technical accuracy and completeness and to mitigate risks. Collaborates with software team in continuous build and deployment process. Excellent problem-solving abilities with a detail-oriented nature. Successful at managing multiple priorities with a positive attitude. Ready to bring related experience to a challenging new role.
- Clinical Trial Management
- Project Management
- FDA/ICH Guidelines
- Key Performance Indicators
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- EDC Software Proficiency
- Database Administration
- Continuous Improvement
- Leadership
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09/2011 to 01/2020 Senior Drug Safety Specialist Cvs Health – Wellesley, MA,
- Analyzed employee data and recommended improvements to processes, procedures and policies to increase productivity and reduce cost of outsourced vendors.
- Navigated intricacies of drug safety databases to process adverse event reports.
- Monitored monthly, quarterly and ad-hoc reports to measure performance metrics to ensure compliance with data quality and contract timelines.
- Conducted more than 15 applicant interviews via telephone and in-person and provided recommendations for employment.
- Provided onboard orientation and training of 25+ new hires over 18-month period, including outsourced vendors.
- Delivered feedback to management regarding new hires and vendors performance and training needs.
- Reviewed employee performance to measure productivity, monitor goal progress and activity levels.
- Tracked vendor project and performance closely to quickly intervene in mistakes or delays.
- Fostered relationships with vendors to promote positive working relationships.
10/2009 to 12/2009 Quality Assurance Analyst Mayo Clinic – Hertel, WI,
- Supported company in maintaining work environment focused on quality, communication, collaboration, integration and teamwork.
- Maintained knowledge of regulatory requirements from accrediting bodies and federal, state and local requirements.
- Fixed identified issues to increase productivity and boost workflows.
- Revised, edited and updated quality assurance manuals and technical documentation used by team.
07/1998 to 11/2008 Certified Clinical Research Coordinator Mayo Clinic – Huntley, MN,
- Assisted with research protocol development. Worked with principal investigator and sponsors to facilitate trial activities and comply with research protocols.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Followed informed consent processes and maintained records.
- Audited charts and reviewed clinical documents to verify accuracy.
- Oversaw quality assurance programs to enhance performance and consistently achieve superior care standards.
- Led projects and analyzed data to identify opportunities for improvement. Developed and implemented performance improvement strategies and plans to promote continuous improvement.
- Revised and evaluated policies and procedures.
- Oriented and trained new staff on proper procedures and policies.
- Focused on scientific review of clinical data analysis, reporting and publishing of findings.
- Co-authored 10 scientific journal publications.
04/1996 to 06/1998 Certified Clinical Research Coordinator VIRTUA Hospital Of Burlington County – City, STATE,
- Worked with principal investigator and sponsors to facilitate trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
- Improved patient follow-up compliance rate from 85% to 100% on RTOG trials.
- Successfully passed NSABP audit for Breast Cancer Prevention Trial and SWOG audit for Prostate Cancer Prevention Trial.
Expected in Bachelor of Arts: Psychology
Rutgers University - Camden, NJ,
GPA:
CTR Certified Tumor Registrar by NCRA
CCRP Certified Clinical Research Professional by SoCRA Lic #8795
Member of ATHENAEUM Honor Society
Member of PSI CHI Honor Society
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