Clinical Research / Study Start-Up Consultant - ICON - Global / Multicenter
Supporting Alkermes Clinical Development Programs. Manage assigned study start-up, feasibility, site activation, TMF, regulatory, vendor, document management, and clinical trial support activities across multiple Phase 2 and Phase 3 studies.
- Support early feasibility by distributing feasibility questionnaires and protocol synopses to potential sites and coordinating Confidential Disclosure Agreement (CDA) completion.
- Maintain start-up, CTA/site, regulatory, IND, protocol amendment, CCC, TMF review, budget, and other study trackers; identify gaps, risks, dependencies, and outstanding actions.
- Monitor site activation and shipment activities, review vendor trackers, and coordinate with CROs, sites, vendors, and study teams to support site readiness and study timelines.
- Perform start-up and post-activation TMF QC, complete TMF Review Sheets, assess documentation for completeness and compliance, and follow up on missing or outstanding records.
- Maintain study documentation in Sponsor SharePoint and applicable TMF systems, including protocols, ICFs, patient-facing materials, meeting minutes, ClinicalTrials.gov records, and essential study documents.
- Coordinate CCC review of patient-facing materials and reference cards, communicate review comments to sites, and coordinate revisions and resubmissions through completion.
- Support regulatory and IND activities through submission tracking, administrative documentation support, and appropriate filing of regulatory records.
- Support monthly ClinicalTrials.gov site-location updates and prepare recurring regulatory/start-up meeting agendas and minutes, documenting decisions, actions, and follow-up.
- Partner with Project Managers, Study Teams, CROs, vendors, regulatory teams, investigative sites, and internal stakeholders to resolve issues and maintain alignment with study timelines.
Assistant Project Manager - ICON - Remote
(2023-11)
FSP AMGEN
- Support study planning and set-up activities, including vendor coordination, project management, and study implementation plans.
- Monitor clinical study deliverables against timelines, budgets, and delegated responsibilities; identify trends and issues and support corrective actions.
- Coordinate site initiation, investigator meeting, and cross-functional meeting activities, including agendas, minutes, and follow-up.
- Support study-level investigational product arrangements, accountability and reconciliation, and procurement/shipment of ancillary clinical supplies.
- Coordinate with study leadership and functional teams on recruitment strategies, study tools, newsletters, and recruitment/retention materials.
- Support preparation and review of study documents, including study guides, monitoring plans, eCRFs, IPIMs, protocol deviation materials, subject information sheets, regulatory submissions, and publications.
- Support IRB/EC submission documentation, global ICF versioning and distribution, vendor oversight, inspection readiness, and TMF maintenance.
- Coordinate with outsourced vendors to organize and deliver essential documents to the TMF and provide regular study updates.
In-House Clinical Research Associate - Criterium Inc. - Remote
(2022-07 - 2023-11)
- Supported clinical study quality and data integrity in accordance with ICH-GCP, regulatory requirements, protocols, and SOPs.
- Tracked Regulatory Authority and Ethics Committee approvals, site regulatory documents, study supplies, and clinical trial activities.
- Performed remote monitoring and on-site co-monitoring activities, including review of site data and documentation where applicable.
- Managed eTMF and CTMS activities, maintained project tracking tools, and supported audit and inspection readiness.
- Worked with sites, clients, vendors, and internal teams to resolve issues, maintain study status, support enrollment activities, and keep study deliverables on schedule.
Clinical Trials Associate / Study Start-Up Specialist - Criterium Inc. - Remote
(2021-03 - 2022-07)
- Supported study start-up and maintenance of regulatory and study documentation across eTMF platforms including Simple Trials, Montrium, OnCore, and Veeva Vault.
- Opened and maintained eTMF records, including FDA 1572s, financial disclosure documents, investigator credentials, delegation logs, safety documentation, and other start-up records; performed eTMF QC.
- Coordinated site start-up activities, document distribution, and IRB/IEC submission preparation while supporting adherence to ICH-GCP, FDA, and local requirements.
- Served as a key contact during site start-up, coordinating communication among project teams, site personnel, sponsors, Regulatory, Contracts, and Legal teams.
- Supported sponsor communications, enrollment tracking, meeting coordination, agenda/minute preparation, SOP/process improvement, and study progress activities.
Regulatory Associate / Clinical Data Manager - Georgetown University Lombardi Comprehensive Cancer Center - Washington, DC
(2018-02 - 2021-03)
- Coordinated IRB submissions, including amendments, consent changes, and deviations, and maintained regulatory updates in OnCore.
- Maintained regulatory files, Trial Master Regulatory Files, essential study documentation, and electronic/paper CRF records across multiple trials.
- Prepared for sponsor/CRO monitoring visits, FDA inspections, and QA reviews; communicated with sponsors, auditors, monitors, physicians, and research staff.
- Reported SAEs in EDC systems including Rave and Oracle and supported compliance with federal regulations, ICH-GCP, and HIPAA requirements.
- Supported Phase I–III clinical trials through data validation, edit checks, patient data listings, study setup, data corrections, and error review.
Certified Pharmacy Technician - ASP Cares Pharmacy - Farmers Branch, TX
(2014-03 - 2018-02)
- Managed patient and prescription data, triage calls, prescription filing, medication shipment labels, inventory, and patient confidentiality requirements.
- Trained new staff and supported consistent pharmacy operations and timely medication delivery.
