Clinical Study Site Activation Specialist

Contract type: temporary, 1 yearHybrid: 2 - 3 days on-siteWorkload: 100%The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.Responsibilities:Responsible for the effective operations and delivery of site activation 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 site activation 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.Requirements:Associate or Bachelor’s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experienceExperience in study start-up is required1-3 years experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contractsKnowledge of clinical trial methodologies, medical terminology, ICH/GCPWorking knowledge of global and local regulatory requirements (IVDR and other applicable regulations)Required to support multi-national team members, and flexibility in working hours may be needed