TFS HealthScience - Contract Research Organization ir globāla līgumisko klīnisko pētījumu organizācija, kas atbalsta biotehnoloģiju un farmācijas uzņēmumus visā klīniskās izstrādes procesā. Tās pakalpojumi ietver I–III fāzes pētījumus, IV fāzes reālās pasaules pierādījumu pētījumus un stratēģisku resursu nodrošināšanu. Organizācijai ir pieredze dermatoloģijā, internajā medicīnā, neirozinātnē, onkoloģijā un hematoloģijā, oftalmoloģijā, pediatrijā, reto slimību un reti sastopamu slimību zāļu jomā. Uzņēmums apvieno pilna servisa CRO iespējas un starptautisko darbības mērogu ar vidēja lieluma organizācijas elastību un personalizētu sadarbību.
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.
Apraksts
- 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
Prasības
- 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%
Priekšrocības
- 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