Attachée de recherche Clinique Senior Freelance

Références

Sr Clinical Research Associate:
 Monitoring of national and international clinical trials for the major industrial sponsors.
 Perform selection, initiation, monitoring, boosting and close-out visits, audits/CAPA.
 Provide a high rate of monitoring visits in a challenging environment - Monitoring a large number of sites in France & Peru.
 Conducting all clinical site activities according to ICH/GCP, monitoring plan, study timelines and company objectives.
 On-site activities: source data verification, drug accountability, safety management, review of investigator site file, GCP training for site staff, audits preparation, CAPA - management and follow up.
 Off-site activities: support to site staffs in eCRF completion and query resolution, review and approval of sites invoices and patient travel reimbursements, management and quality control of Trial Master File.
 Involved in the start-up activities follow-up, administrative documents collection and follow-up of contract negotiations between sites directions and Start-up depts (IQVIA).
 Manage interim and final analysis within timelines in order to meet sponsor’s expectations.
 Building relationships with investigators and site study teams.
 Discussing with PIs on recruitment strategies
 Regular calls with PI and dedicated staff to discuss patient recruitment enhancement methods.
CRAs Manager & Site Relationship Manager:
 CRAs management (18p): Recruiting, Onboarding, Training, Performances analysis
 36 bi-annual interviews per years (behavioral competencies + metrics)
 Operational management of French Academics Hospitals (Bordeaux + Toulouse) + Oncology sites (Oncopole & Bergonié) : increase studies portfolio, increase patients recruitment
 National referent on patient recruitment for 2 sponsors: direct calls with sponsors, bi-weekly review (7 pts enrolled within 2weeks)
 Responsible for France SDV backlog: analysis, actions & FU (09/17: 78 DOS needed → 01/18: 0 DOS needed)
 Responsible of project studies review with Sponsor
 Responsible of audits preparation on my area (large South West France) & CAPAs FU (2017: 7 audits - no majors / 2018: 4 audits no majors)
 Operational management of partnership sites
 Transversal management & coordination from feasibility to SIV to ensure productivity, delivery and quality (70 studies: 10 SSV/ 20 RSU / 30 on going / 10 enrollment closed)
 ICH-GCP Trainer for investigators and sites staff (2016 to 2018: 300p)

Etudes

2025 ICH/GCP E6 (R2) Certification – training and certification provided by customer (Global CRO)
2018 New French law in Clinical Research – Jarde’s law
ICH/GCP E6 (R2) Certification – training and certification provided by IQVIA.
2010 – 2018
2003 Expert ICH/GCP Exam for Managers and Staff interacting with investigational sites – training and certification provided by Barnett Accreditation.
CRA training, Supsanté – Paris, France
1998 Master II degree Psychology – Angers University, France