Clinical Research Coordinator, Oncology

Position Summary:

RapidTrials seeks an onsite coordination and data support for an industry sponsored study of an investigational medicine for advanced. metastatic or recurrent head and neck squamous cell carcinoma. The focus is accurate study data, timely query resolution and well maintained site documentation.

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Contract Terms/Scope

• Approximately 8 hours per week (96 hours over 12 weeks), scheduled around participant visits and protocol deadlines.
• On site position in Marseille, France (no remote work optoinO
• Independent professional services through your own French registered micro-entreprise (auto-entreprise); this is not a salaried or fixed term employment position
• Hourly fee agreed in euros excluding VAT; the fee is business revenue, not net salary, and must cover your costs (travel, parking, meals); no expense reimbursement
• You are responsible for your own declarations, taxes, social security contributions and insurance; no employee benefits or paid leave are provided
• You deliver the agreed services autonomously and may work for other clients, subject to confidentiality and agreed commitments
• A written agreement will set out services, outputs, fees, invoicing, training, duration and termination before services begin; scope or budget changes require prior written agreement

Scope of services

• Enter and reconcile study data in Medidata Rave and other approved EDC systems; resolve factual queries within
• agreed timelines and refer clinical questions to the investigator
• Prepare and maintain the investigator site file, training and delegation records, study logs and consent, screening,
• enrolment and randomisation records; support submissions to the CPP and ANSM
• Prepare documents for monitoring visits, audits and inspections; join study calls and help close documented follow up
• actions; coordinate timely investigator review of patient data and lab results
• Coordinate visit logistics and provide approved practical information to participants and caregivers; support
• administration of participant travel reimbursements
• Promptly escalate potential adverse events, serious adverse events, protocol deviations and safety concere
• investigator; support safety documentation within the authorised delegation
• Out of scope: medical or nursing procedures, clinical examinations or vital signs, prescribing, independent eligibility decisions, clinical interpretation of results, and the medical informed consent discussion.

Experience and skills

• At least 2 years of clinical research coordination or relevant research nurse experience, including oncology studies;prior nursing experience does not expand the non medical scope
• Hands on Medidata Rave experience, including data entry and query resolution
• Current documented ICH-GCP (BPC) training; working knowledge of French and European trial requirements, xgjwbzu ethics
• review and confidentiality obligations
• Fluent written and spoken French and English; strong organisation, attention to detail and proficiency with Microsoft
• applications and electronic study systems
• Relevant bachelor's degree or equivalent preferred; suitable clinical research experience may substitute
• Before services begin
• Evidence of business registration (SIREN/SIRET) and eligibility to perform the activity independently in France; anyimmigration permission must allow independent activity
• Professional civil liability insurance appropriate to the services; URSSAF attestation de vigilance and other required
• contracting documents where applicable
• Any permission needed to combine this assignment with existing employment, including public hospital employment
• Protocol, site, confidentiality, data security and system training completed, with authorised individual access to
• Medidata Rave, before trial activities start