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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. Contract Terms/ScopeApproximately 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 optoinOIndependent professional services through your own French registered micro-entreprise (auto-entreprise); this is not a salaried or fixed term employment positionHourly fee agreed in euros excluding VAT; the fee is business revenue, not net salary, and must cover your costs (travel, parking, meals); no expense reimbursementYou are responsible for your own declarations, taxes, social security contributions and insurance; no employee benefits orpaid leave are providedYou deliver the agreed services autonomously and may work for other clients, subject to confidentiality and agreed commitmentsA written agreement will set out services, outputs, fees, invoicing, training, duration and termination before services begin; scope or budget changesrequire prior written agreementScope of servicesEnter and reconcile study data in Medidata Rave and other approved EDC systems; resolve factual querieswithinagreed timelines and refer clinical questions to the investigatorPrepare 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 ANSMPrepare documents for monitoring visits, audits and inspections; join study calls and help close documented follow upactions; coordinate timely investigator review of patient data and lab resultsCoordinate visit logistics and provide approved practical information to participants and caregivers; supportadministration of participant travel reimbursements Promptly escalate potential adverse events, serious adverse events, protocol deviations and safety concereinvestigator; support safety documentation within the authorised delegationOut 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 skillsAt least 2 years of clinical research coordination or relevant research nurse experience, including oncology studies; Prior nursing experiencedoes not expand the non medical scopeHands on Medidata Rave experience, including data entry and query resolutionCurrent documented ICH-GCP (BPC) training; working knowledge of French and European trial requirements, ethicsreview and confidentiality obligationsFluent written and spoken French and English; strong organisation, attention to detail and proficiency with Microsoftapplications and electronic study systemsRelevant bachelor's degree or equivalent preferred; suitable clinical research experience may substituteBefore services beginEvidence 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 requiredcontracting documents where applicableAny permission needed to combine this assignment with existing employment, including public hospital employmentProtocol, site, confidentiality, data security and system training completed, with authorised individual access toMedidata Rave, before trial activities start

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