TFS HealthScience - Contract Research Organization este o organizație globală de cercetare în baza unui contract, care sprijină companiile de biotehnologie și farmaceutice pe parcursul dezvoltării clinice. Serviciile sale includ studii din fazele I–III, studii de fază IV privind dovezile din lumea reală și furnizarea strategică de resurse, cu expertiză în dermatologie, medicină internă, neuroștiință, oncologie și hematologie, oftalmologie, pediatrie, boli rare și medicamente orfane. Compania combină capacitățile și acoperirea internațională ale unei organizații de cercetare clinică cu servicii complete cu flexibilitatea și colaborarea personalizată ale unei organizații de dimensiune medie.
Senior Clinical Research Associate, Oncology - France Remote
Lead clinical trial site monitoring for oncology studies at TFS HealthScience, supporting participant safety, protocol compliance, data quality, and regulatory standards.
Descriere
- Support the Project Team in the operational delivery of clinical studies
- Initiate, monitor, and close clinical trial sites through on-site and remote visits
- Conduct trial monitoring in line with company and sponsor SOPs, GCP/ICH guidance, and applicable regulations
- Evaluate subject safety, data integrity, and study quality through monitoring activities
- Confirm proper informed consent processes and adherence to study protocols
- Review electronic or paper CRFs alongside source records
- Check the handling, reconciliation, and accountability of investigational products
- Prepare monitoring visit reports, record findings and corrective or preventive actions, maintain tracking systems, and escalate concerns
- Communicate identified issues and required follow-up actions to study sites
- Submit site documentation to the eTMF or paper TMF and confirm Investigator Site File maintenance
- Support preparation for audits and inspections and complete related follow-up
- Order, ship, and reconcile clinical study supplies when required
- Maintain accurate site information in CTMS and other project systems
- Work exclusively with one global pharmaceutical or biotechnology sponsor
Cerințe
- Bachelor’s degree in life sciences or nursing preferred, or an equivalent qualification
- At least three years of oncology monitoring experience
- At least one year of experience in Phase I or II oncology studies
- Strong working knowledge of GCP and ICH standards
- Fluent English communication skills
- Comfort working in a fast-paced environment with shifting priorities
- Ability to work independently within a matrix team structure
- Strong written and verbal communication abilities
- Excellent organizational and coordination skills
- Confidence using technology, software, and computer systems
- Self-awareness, determination, flexibility, initiative, collaboration, analytical thinking, and close attention to detail
- Willingness and ability to travel up to 60–80%
Beneficii
- Personal and professional development opportunities
- Purposeful and rewarding work environment
- Team culture centered on collaboration
- Strong focus on quality
- Opportunity to contribute to improved patient outcomes
- Flexible clinical development and strategic resourcing solutions