International Cra- Sites in France, Spain and
il y a 1 semaine
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries.
Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.We are seeking for a
CRA to be responsible for all aspects of study site monitoring and management. As part of this role, the CRA is responsible and accountable for site monitoring and site management.
They have responsibility for rare disease registries according to Company and Sponsor Standard Operating Procedures (SOP), and local regulatory guidelines.
The CRA is the primary Rare Disease Registries representative for the sites.Essential duties:
The CRA is the first point of contact for the Principal Investigator and other site staff performing the rare disease registries at the Investigational Site
Feasibility Activities
- Involvement in the site selection process together with the Clinical Project Lead (CPL), Registries Regional Leads and Local Medical Affairs.
Study Start-up Activities:
- Assist in the collection of site documents for the Health Authority (HA)/Regulatory Authority (RA) submission and Ethics Committees (EC)/ Institutional Review Board (IRB)
- Review and check the quality of the site and study documents to submit with IRB/EC central, local, hospital committee and HA/RA.
- Prepare EC cover letter and any additional materials required
- Ensure appropriate followup with EC for additional questions and to inform sites
- Assist from the Site Contract process with the collection of the site documents required, to the budget negotiation and final agreement with the sites
- Ensure Inform Consent Form (ICF) customization based on country requirements, incorporate site details, and perform appropriate quality review and version tracking per site
- Assist with the upload & file of Study Startup documentation into the eTMF.
Site Monitoring:
Onsite and Off-Site Visits
in France, Spain and Portugal (majority of sites are in France)
Plan, prepare, conduct, report and follow up site (and satellite sites) visits - Site Selection, Site
Initiation, Routine Monitoring (Remote / On-site) and Close Out Visits according to Study
Manual, Protocol, Local Regulation, Good Clinical Practice (GCP) and SOPs. High level of remote visits vs onsite visits considering the type of site/number of patients.
No IMP management
Average of 4 to 5 days on site
Management of the Site Data
Follow up of trial progress and quality control of data (source document check). Review of electronic Case Report Form (eCRF) completeness and query resolution by the sites. Escalate issue(s), when necessary. To maintain contact with Data Management group. To coordinate international data collection projects.
Site Management
Recruitment
Follow up on patient enrolment and patient status.
Site facility & staff
Assure that site facilities are adequate, according to protocol needs, local regulations, GCP and
applicable SOPs (global/local). Assure site staff training and access to different systems.
Safety & Quality:
Assure adequate safety reporting process of the site, and that site is submitting and/or
notifying safety information to EC/IRB/RA according to country regulations, site SOP.
To monitor the safety of registries at the site level Quality control of study conduction at site level - with "audit/inspection readiness" mindset.
Study administration:
To maintain all the tables, trackers and databases updated to follow the study progress locally and globally.
To know and use all the tools needed.
To ensure TMF compliance by contributing to the eTMF process during the entire study duration (from the set-up to the archiving) in collecting site documents required.
Study Meetings:
To participate with the rest of the study team in local and international investigators and/or monitors meetings (where required), study/operational meetings, quality audits and inspections for the re
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