Ellen Recchion
Wilmington,NC
Summary
Accomplished Study Start-Up Professional with a strong background in accelerating clinical trial initiation. Manages essential documentation and coordinates regulatory submissions, ensuring compliance and operational efficiency. Facilitates collaboration among sponsors, investigational sites, and regulatory agencies. Therapeutic expertise includes oncology, cardiovascular, central nervous system, ophthalmology, psychiatry, and neurology.
Overview
8
8
years of professional experience
Work History
Senior Site Activation Specialist
Syneos Health
Morrisville, North Carolina
06.2023 - Current
- Forecasted submission timelines while ensuring real-time compliance tracking within SSU systems. Identified delays through data analysis, offering contingency plans for resolution.
- Oversaw delivery of quality outcomes at country level, following project specifications and regulations closely.
- Managed submissions to trial master file according to established company protocols and sponsor requirements.
- Collected essential documents from site and compile regulatory green light packages for site activation.
- Prepared and submitted Central EC Applications, Local EC Applications, RA Applications, and other
local regulatory authorities or hospital approval submissions as required - Oversaw ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with minimal
oversight from the SSU Country Manager. - Acted as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversaw site activation end to end process at country/
site level. - Coordinated activation plans with cross-functional teams to ensure project alignment.
Senior Clinical Project Team Associate
PharPoint
Wilmington, North Carolina
04.2019 - 06.2023
- Mentored project team associates and managed clinical interns, enhancing team integration and knowledge transfer.
- Developed multiple study start up and essential document trainings for the clinical department.
- Assisted with implementation of multiple new systems for the clinical department (eTMF, CTMS, and eISF).
- Managed the clinical tasks associated with start-up, maintenance and close out.
- Facilitated internal and external meetings, tracked attendance, prepared all agendas, documented meeting minutes and outstanding action items for all attendees.
- Facilitated the execution of confidentiality agreements with potential investigative sites.
- Distributed Site Feasibility Questionnaires to potential investigative sites and compiled responses.
- Completed submissions and served as primary owner for study specific Central IRB tracking.
- Led essential document collection and review activities for site activation.
- Facilitated informed consent reviews with sites and conducted initial reviews to ensure compliance and clarity.
- Served as central contact for clinical project team and investigative sites, streamlining project-related communications.
- Prepared, handled and distributed Site Reference Manual, Investigator Site Binders, Pharmacy Manual and any other relevant study-specific manuals. Facilitates and tracks any study-specific third-party vendor equipment and system access.
- Functioned as the Subject Matter Expert (SME) for the company’s CTMS by tracking, maintaining and reporting all project related information, as applicable.
- Actively participated in responding to internal/external QA audit report findings with direction from the project manager.
Clinical Trials Administrator
Chiltern International
Wilmington, North Carolina
02.2018 - 04.2019
- Prepared study site files following relevant SOPs to ensure compliance and readiness for audits
- Assisted in the tracking and filing of documents for all clinical studies into Chiltern’s global database
- Documented and tracked study activities using relevant forms and tools, as well as relevant Project Management System with guidance/support
- Created and maintained contact list of study team members, study sites, and external suppliers’/contract organizations
- Took minutes and documented key decisions during sponsor/external and internal teleconferences to maintain accurate records
- Assisted in setting up and maintaining tracking systems for e.g. study supplies and investigator payments
- Liaised with Chiltern departments to facilitate coordination and communication for effective study execution
Education
Bachelor of Science - Business Administration
North Carolina State University
Raleigh, NC05-2014
Skills
- Regulatory compliance
- Project forecasting
- Quality assurance
- Submission management
- Site activation processes
- Document tracking
- Effective communication
- Problem solving
- Meeting facilitation
Timeline
Senior Site Activation Specialist
Syneos Health
06.2023 - Current
Senior Clinical Project Team Associate
PharPoint
04.2019 - 06.2023
Clinical Trials Administrator
Chiltern International
02.2018 - 04.2019
Bachelor of Science - Business Administration
North Carolina State University