{"id":3554906,"url":"https://alion.io/job/icon-study-start-up-clinical-research-associate","title":"Study Start Up Clinical Research Associate","company":{"id":5677,"name":"ICON","domain":"iconplc.com","url":"https://alion.io/company/icon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":56,"ghost_share":0,"stale_share":0.839,"repost_share":0,"time_to_fill_p50_days":15,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Kenya"],"countries":["KE"],"hiring_countries":["KE"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":16000,"max_usd":41000,"period":"year","method":null,"sample_n":1456},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"closed","first_seen_at":"2026-10-29T00:00:00Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-03T22:24:54Z","board_verified":false,"closed_at":"2026-11-03T22:24:54Z","days_open":5,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":5},"description":"Study Start Up Clinical Research AssociateAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.\nAs the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.\nAs a Study Start-Up Clinical Research Associate at ICON, you will be responsible for managing site-level study start-up activities from site selection through to site activation, ensuring clinical trial sites are activated efficiently and in accordance with ICH-GCP, local regulatory requirements, and applicable SOPs.\nWhat You Will Do:\nIn this role, you will take ownership of end-to-end study start-up activities for assigned clinical trial sites, acting as a key point of contact for investigational sites and collaborating closely with internal study teams to achieve start-up milestones.\nKey responsibilities include:\nManage end-to-end study start-up activities for assigned sites, from site selection through to site activation\nConduct site selection activities and assess site suitability, working directly with Principal Investigators and investigational site teams\nIndependently prepare, coordinate, and manage regulatory authority and Ethics Committee/IRB/IEC submissions, including responding to queries and resolving deficiencies\nCoordinate the collection, review, and tracking of essential regulatory documentation, including ICFs, CVs, GCP certificates, financial disclosures, and other site-specific documents\nMaintain study start-up systems, trackers, and country/site TMF documentation, ensuring documentation is complete, accurate, and inspection-ready\nPartner with sites and internal stakeholders to proactively resolve start-up issues, support vendor, contract, and investigator payment activities where required, and minimise activation delays\nEnsure sites are fully prepared for site activation and coordinate a seamless handover to the execution CRA\nYour Profile:\nTo succeed in this role, you will bring strong clinical trial study start-up and regulatory experience, with the ability to independently manage site activation activities and regulatory submissions.\nRequired qualifications and experience:\nPrevious experience in clinical trial study start-up, site activation, and regulatory submissions\nDemonstrated experience independently managing end-to-end site start-up activities through site activation\nProven experience independently preparing and managing regulatory authority and Ethics Committee/IRB/IEC submissions, including responding to regulatory and ethics queries\nStrong knowledge of ICH-GCP, local regulatory requirements, essential regulatory documentation, and TMF requirements\nStrong organisational and stakeholder-management skills, with the ability to manage multiple sites, timelines, and competing priorities independently\nCandidates must be based in either Nairobi or Kisumu, Kenya.\nEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.\nRewards & Benefits\nICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.\nBenefits may include:\nCompetitive base salary and performance related incentives\nHealth and wellbeing programmes including medical, dental, and vision coverage where applicable\nRetirement and pension plans\nLife assurance and disability coverage\nEmployee assistance programmes and wellbeing resources\nLearning and development opportunities through structured training and career pathways\nBenefits may vary depending on role and location.\nVisit our careers site to read more about the benefits ICON offers.\nInclusion and Accessibility\nICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.\nIf you require reasonable accommodations during the recruitment process, please let us know or submit a request here.\nAre you a current ICON Employee? 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