Shantia Shears
Maryland Heights,Missouri
Summary
Experienced CRA with many years in the clinical research industry of which 12 years were clinical trial monitoring experience. Thorough knowledge of FDA and GCP principles and regulations. Completed work on trials from site selection, start-up to close-out and experienced in conducting PSSVs, SIVs, IMVs, and COVs. Has served as a visit leader and mentor for coworkers. Experience with site feasibility, site selection/initiation/monitoring/close-out visits, budget/contract negotiations, study metrics tracking, development of project management and monitoring plans, development and implementation of monitoring tools, EDC, GCP/ICH, and investigator meetings. Therapeutic experience includes; oncology, endocrinology, virology, ophthalmology, psychiatry, neurology, vaccines, sexual health and device studies
Overview
16
16
years of professional experience
Work History
Clinical Research Associate 3
ICON PLC
Lenexa, KS
09.2022 - Current
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & Provides inputs on site selection and Validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased Subjects’ right, safety and well-being are protected.
- Facilitates audits and audit resolution.
- Mentors junior level CRAs and serves as a resource for new employees.
Principal Clinical Research Associate
SYNTERACT, A SYNEOS HEALTH COMPANY
Carlsbad, CA
07.2021 - 09.2022
- Monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate
- Ensured timely completion of all deliverables by tracking project timelines and milestones
Senior Clinical Research Associate
ICON/formerly PRA Health Sciences
North Wales, PA
11.2015 - 07.2021
- Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely.
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations were being met and were compliant with applicable local regulatory requirements and ICH-GCP guidelines.
- Prepared reports summarizing findings from monitoring visits.
Senior Clinical Research Associate
IQVIA, formerly Quintiles
Overland Park, KS
09.2014 - 10.2015
- Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues.
Clinical Research Associate 2
Parexel
Billerica, MA
10.2012 - 09.2014
- Conducted the clinical monitoring aspect of designated projects in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products
- Performed clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection)
- Performs essential document site file reconciliation.
Clinical Research Associate
PPD
Austin, TX
04.2011 - 10.2012
- Performed and coordinated assigned aspects of the clinical monitoring process in accordance with
GCPs and global SOPs to assess the safety and efficacy of investigational product - Ensured site compliance to the protocol and applicable regulations (FDA/GCP/ICH/IRB).
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
Clinical Research Coordinator
The Retina Institute
St Louis, MO
02.2008 - 03.2011
- Responsible for all logistical functions of the conduct of select phase II-III clinical trials, including: screening and enrollment, investigational product accountability, case report form completion and source document completion.
- Trained and certified in: Medidata-Rave EDC, Inform ITM-Phase Forward EDC, and Oracle EDC.
- Assisted in protocol design and budget preparation for two Independent Investigator Trials.
- Experienced using IVRS/IWRS.
Education
Master of Arts - Biology
Washington University in St Louis
St Louis, MO05-2007
Bachelor of Science - Anthropology
Washington University in St Louis
St Louis, MO05-2005
Skills
- Site Management
- Patient recruitment strategies
- Detailed documentation
- Interdepartmental Collaboration
Accomplishments
Successful completion of the Oncology University program, which consisted of completion of the following components with a passing grade: Over 30 hours of on-line training on cancer topics through the internal ICON/PRA LMS including Barnett certified oncology specific curriculum
External on-line Oncology Nursing Society course - Cancer Basics rated at 6.4 hours of continuing education credits
Four day workshop with a final examination designed to assess aspects of basic oncology monitoring, including RECIST, IP dosing/calculations, CTCAE grading and AE assessment and overall oncology
specific protocol compliance issues.
Timeline
Clinical Research Associate 3
ICON PLC
09.2022 - Current
Principal Clinical Research Associate
SYNTERACT, A SYNEOS HEALTH COMPANY
07.2021 - 09.2022
Senior Clinical Research Associate
ICON/formerly PRA Health Sciences
11.2015 - 07.2021
Senior Clinical Research Associate
IQVIA, formerly Quintiles
09.2014 - 10.2015
Clinical Research Associate 2
Parexel
10.2012 - 09.2014
Clinical Research Associate
PPD
04.2011 - 10.2012
Clinical Research Coordinator
The Retina Institute
02.2008 - 03.2011
Master of Arts - Biology
Washington University in St Louis
Bachelor of Science - Anthropology
Washington University in St Louis
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