Shayla M
- Role
- Clinical Trial Site Management Associate i at ICON plc
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Shayla M
I love collaborating with team members to facilitate urgent requests with the fast-paced…
Experience
Clinical Trial Site Management Associate i
Sep 2022 — Present
Acts as primary site contact/liaison for study/site management issues; completes submissions and notifications to regulatory authorities and ethic committees • Collects, organizes and maintains site clinical trial master file (TMF) documents, and maintains site-related data in applicable systems according to procedures and guidelines throughout the study lifecycle • Works in several site specific eRegulatory systems including Box, Complion, Florence, RDMS, and Syncplicity • Mentors and trains new employees as part of peer-to-peer mentoring program to improve efficiency of onboarding process • Preforms onsite visits as needed to ensure sponsor and investigator obligations are being met and are compliant with applicable regulatory requirements and guidelines • Maintains subject status tracker throughout enrollment on study • Experience managing Phase I through and Global/International Clinical Trials following FDA and IRB/IEC guidelines • Collaborates with Clinical Trial Managers (CTM) and Clinical Research Assistants (CRA) to accurately update / maintain clinical systems to track site compliance and performance within project timelines • Assists with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information • Determines, track, review milestones tasks, timelines and for all clinical activities for assigned projects, ensuring adherence to contract and budget • Completes submissions of Amended protocol level documents (IB, ICF, Protocol, Subject Recruitment Materials) and Continuing review documents on behalf of central sites • Provides Vendor access to site contacts and also followed up with sites regarding aging Data management queries and SAE report acknowledgement • Utilizes translation services for all required subject related material and submits on behalf of investigational site
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.