Assistant Cra - Ivry-sur-Seine, France - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Entreprise vérifiée
Ivry-sur-Seine, France

il y a 1 mois

Sophie Dupont

Posté par:

Sophie Dupont

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Description

Assistant CRA - Marseille, Bordeaux, Paris, Nantes, Lyon - Home based
We are vital links between an idea for a new medicine and the people who need it.

We are the people of PPD, part of Thermo Fisher Scientific — thousands of employees in locations worldwide connected by tenacity and passion for our purpose:
to improve health.

You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.


We currently have an opportunity for an Assistant CRA to join our Clinical Monitoring department, working home based in Marseille, Bordeaux, Paris, Nantes or Lyon.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.


As a Remote Site Monitor/Assistant CRA, you will perform remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents by reviewing study data from various sources remotely.

You will contact study sites to collect study documentation, resolve issues and request outstanding information.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.

We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.


Summarized Purpose:


  • Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logístical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study startup, site management, recruitment and close out phases.

Essential Functions and Other Job Information:

  • Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
  • Completes and documents studyspecific training
  • Orients and trains on any CRG/studyspecific systems
  • Provides inhouse support during prestudy assessments and with prestudy asssessment waivers, as agreed for project
  • Supports to customize Site ICF with site contact details, as needed
  • Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments
  • Verifies document collection and RCR submission status; updates site EDL and verifies site information
  • Reviews patient facing materials and review translations, as directed
  • Supports site staff with the vendor related qualification process, where applicable
  • Provides support by ensuring system access is requested/granted and revoked for relevant site staff during preactivation and subsequent course of the study
  • Provides support to followup on site staff training, as appplicable
  • Coordinates and supports logistics for IM attendance, as directed
  • Support with maintenance of vendor trackers, as directed
  • Coordinates study/site supply management during preactivation and subsequent course of the study
  • Supports Essential Document collection, review and updating in systems, as applicable
  • Follow up and supports on missing study vendor data like ECGs, lab samples, and ediaries, as directed
  • Supports ongoing remote review of centralized monitoring tools, as directed
  • Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and followsup on site invoices throughout the study period
  • Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable
  • Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed
  • May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix
  • May perform a specific role profile for FSP opportunities according to Client requests
  • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience:
Bachelor's Degree in a life science-related field OR Registered Nurse license along with an Associate's Degree in Nursing. Current PPD CRAs qualify to be considered for this role without having the degree requirements.


Prior clinical research experience ~ 1-2 years as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities.

In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data m
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