{"id":3317728,"url":"https://alion.io/job/merck-co-clinical-research-associate-6","title":"Clinical Research Associate","company":{"id":3768,"name":"Merck & Co.","domain":"msd.com","url":"https://alion.io/company/msd","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":99,"open_postings":149,"ghost_share":0.02,"stale_share":0.101,"repost_share":0.161,"time_to_fill_p50_days":15,"computed_at":"2026-10-30T05:48:23Z"}},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Petaling Jaya, Malaysia"],"countries":["MY"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":13000,"max_usd":33000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":183},"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Matter","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-27T06:11:33Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-10-30T15:08:09Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Job Description\nThe Clinical Research Associate (CRA) is accountable for the performance and compliance of assigned clinical study protocols and investigational sites within the country. Under the oversight of the CRA Manager, the CRA ensures that study conduct complies with ICH-GCP guidelines, local regulatory requirements, sponsor policies and procedures, quality standards, and adverse event reporting requirements.\nThe CRA serves as the primary site contact and site manager throughout all phases of a clinical research study, assuming overall responsibility for assigned sites. The role also contributes to the development of clinical research capabilities by identifying and cultivating new investigator sites and participating as a subject matter expert (SME) in monitoring processes and systems.\nKey Responsibilities\nSite Management & Monitoring\nDevelop and maintain strong relationships with investigational sites throughout all phases of the clinical trial lifecycle.\nPerform site management and monitoring activities in accordance with: ICH-GCP guidelines Sponsor SOPs Local laws and regulations Study protocol requirements Site Monitoring Plans and associated study documents\nGain a comprehensive understanding of study protocols and related procedures.\nCoordinate and manage site readiness activities in collaboration with cross-functional stakeholders.\nParticipate in site selection, qualification, and validation activities.\nConduct remote and on-site monitoring activities to ensure: Data generated at sites are complete, accurate, and unbiased. Participant rights, safety, and well-being are protected.\nConduct site visits including: Site qualification/validation visits Site initiation visits (SIV) Interim monitoring visits Close-out visits\nPrepare clear, comprehensive, and timely visit reports and documentation.\nRegulatory & Compliance Management\nCollect, review, and maintain required regulatory documentation throughout study startup, maintenance, and close-out phases.\nEnsure compliance with applicable regulations, study protocols, and quality standards.\nSupport audit and inspection readiness activities.\nAssist with or lead audit and inspection activities when required.\nPerform co-monitoring visits as appropriate.\nMaintain accurate and timely documentation within CTMS, eTMF, and other clinical systems.\nSite Performance & Issue Management\nCommunicate with investigators and site personnel regarding: Protocol implementation Patient recruitment and retention Protocol deviations Regulatory documentation Audits and inspections Overall site performance\nIdentify, assess, and resolve site performance, quality, and compliance issues.\nEscalate risks and concerns through established escalation pathways when appropriate.\nConduct root cause analyses and implement preventive and corrective actions (CAPAs).\nMonitor recruitment performance and support enrollment strategies.\nCross-Functional Collaboration\nCollaborate closely with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, ethics committees, and regulatory authorities.\nSupport study delivery through effective stakeholder management and coordination.\nContribute to team development by acting as: Subject Matter Expert (SME) Mentor or buddy Best-practice contributor\nSite Development\nSupport country clinical research strategies by identifying and evaluating new investigator sites.\nPartner with investigators and sites to enhance clinical research capabilities and performance.\nExpand and strengthen the local clinical research network.\nTravel Requirements\nDomestic and international travel of approximately 65%-75% of working time.\nExpected travel frequency of approximately 2-3 days per week.\nCore Competencies\nClinical & Technical Expertise\nFluency in local language(s) and English, both written and verbal.\nStrong understanding of: Clinical research processes Clinical trial phases ICH-GCP guidelines Country-specific clinical research regulations\nKnowledge of global and regional clinical research requirements.\nStrong understanding of Good Documentation Practices (GDP).\nProven site management and patient recruitment experience.\nDemonstrated monitoring expertise and sound professional judgment.\nAbility to analyze data and performance metrics and take appropriate action.\nSystems & Technology\nProficiency in Microsoft Office applications.\nExperience using clinical systems such as CTMS, eTMF, and mobile monitoring tools.\nAbility to quickly adopt new technologies and applications.\nProblem Solving\nAbility to manage complex issues and work in a solution-oriented manner.\nExperience conducting root cause analyses and implementing corrective and preventive actions.\nStrong risk assessment and decision-making capabilities.\nBehavioral Competencies\nExcellent time management and organizational skills.\nStrong interpersonal and communication skills.\nEffective conflict resolution and problem-solving abilities.\nAbility to work independently across multiple studies, sites, and therapeutic areas.\nStrong sense of accountability, urgency, and ownership.\nAbility to prioritize competing demands in a fast-paced environment.\nDemonstrated success working in multicultural and matrixed organizations.\nStrong customer-focused mindset.\nCommitment to quality, compliance, and continuous improvement.\nPositive attitude, growth mindset, and self-driven work ethic.\nProfessional presence and communication style aligned with organizational standards.\nQualifications & Experience\nBachelor's Degree or higher in a scientific or healthcare-related discipline; and\nMinimum 2 years of direct site management/monitoring experience within a pharmaceutical, biotechnology, or CRO environment.\nAdditional location(s) Compensation Information:\nRequired Skills:\nAccountability, Accountability, Adaptability, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Conflict Management, Cultural Awareness, Customer Centricity, Customer-Focused, Data Analysis, Data Documentation, Data Reporting, Decision Making, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth Mindset, Matrix Management, Multitasking, Protocol Adherence {+ 6 more}Preferred Skills:\nCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nSearch Firm Representatives Please Read Carefully\nMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.\nEmployee Status:\nRegularRelocation:\nVISA Sponsorship:\nTravel Requirements:\nFlexible Work Arrangements:\nHybridShift:\nValid Driving License:\nHazardous Material(s):\nJob Posting End Date:\n11/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. 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