Site Activation Specialist > Eurojob > Joboolo FR :
Société : Eurojob Lieu : Risch Zoug
BeschreibungFor our international medical partner, Roche Diagnostics Int Ltd.
based in Rotkreuz, we are looking for a qualified and motivated SiteActivationSpecialist for one year with option for extension.The SiteActivationSpecialist is responsible for site start-up activities for the assigned studies within the Site Alliance and SiteActivation Sub-Chapter under Clinical Operations.
The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.TasksResponsible for the effective operations and delivery of siteactivation deliverables across all regions, within the assigned projectsSupports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility informationMaintain regular communications with investigational sites/CRO to ensure timely completion of the required siteactivation activities/documentation and resolve or escalate issues in a timely mannerCollect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirementsCoordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teamsWork with sites to ensure informed consent form meets the required regulatory and company requirementsFacilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/ECCoordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical studySupport contract and budget negotiations in partnership with Contracting and Study TeamsEnsure Purchase orders and Fair Market Value assessments are completed for timely start-start upSupport study instrument placements, Obtain import/export licensureSupport implementation and use of eTools at the siteCollect and maintain relevant country, local, state, and site-level regulatory intelligence for future useWork closely with Study Teams to deliver study start-up tasksSolve identified issues with appropriate timely escalation to the Study TeamsSupport internal audit and external inspection activities; contribute to CAPAs as required Must HavesBachelor’s or Master’s (no PhD) degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experienceExperience in study start-up is required or experience as CRA or within clinical research / trialExperience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contractsKnowledge of clinical trial methodologies, medical terminology, ICH/GCPMust be fluent in English, German is a plusUnderstand the quality expectations and emphasis on the right first time, attention to detailAbility to organize tasks, time, and priorities, ability to multitaskRequired to support multi-national team members, and flexibility in working hours may be neededAbility to participate and work effectively with multiple cross-functional teamsAbility to work in an ambiguous environment and great communication skills Nice to HavesExperience with CRO management is a plusWorking knowledge of global and local regulatory requirements (IVDR and other applicable regulations) is a plusAdditional European language are a plus Are you interested? Do not hesitate and submit your complete application documents online today.We also process applications by post, but will not return them for administrative reasons.
We look forward to hearing from you! Eurojob RischZoug
