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Clinical Research Associate

Msd

The Clinical Research Associate (CRA) is accountable for the performance and compliance of assigned clinical study protocols and investigational sites within the country.

Responsibilities

  • 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.
  • The 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.
  • Site Management & Monitoring Develop and maintain strong relationships with investigational sites throughout all phases of the clinical trial lifecycle.
  • Perform 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 Gain a comprehensive understanding of study protocols and related procedures.
  • Coordinate and manage site readiness activities in collaboration with cross-functional stakeholders.
  • Participate in site selection, qualification, and validation activities.
  • Conduct 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.
  • Site qualification/validation visits Site initiation visits (SIV) Interim monitoring visits Close-out visits Prepare clear, comprehensive, and timely visit reports and documentation.
  • Regulatory & Compliance Management Collect, review, and maintain required regulatory documentation throughout study startup, maintenance, and close-out phases.
  • Ensure compliance with applicable regulations, study protocols, and quality standards.
  • Support audit and inspection readiness activities.
  • Assist with or lead audit and inspection activities when required.
  • Perform co-monitoring visits as appropriate.
  • Maintain accurate and timely documentation within CTMS, eTMF, and other clinical systems.
  • Site Performance & Issue Management Communicate with investigators and site personnel regarding: Protocol implementation Patient recruitment and retention Protocol deviations Regulatory documentation Audits and inspections Overall site performance Identify, assess, and resolve site performance, quality, and compliance issues.
  • Escalate risks and concerns through established escalation pathways when appropriate.
  • Conduct root cause analyses and implement preventive and corrective actions (CAPAs).
  • Monitor recruitment performance and support enrollment strategies.
  • Collaboration Collaborate closely with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, ethics committees, and regulatory authorities.
  • Support study delivery through effective stakeholder management and coordination.
  • Contribute to team development by acting as: Subject Matter Expert (SME) Mentor or buddy Best-practice contributor Site Development Support country clinical research strategies by identifying and evaluating new investigator sites.
  • Partner with investigators and sites to enhance clinical research capabilities and performance.
  • Expand and strengthen the local clinical research network.

Requirements

  • Expected travel frequency of approximately 2–3 days per week.
  • Core Competencies Clinical & Technical Expertise Fluency in local language(s) and English, both written and verbal.
  • Clinical research processes Clinical trial phases ICH-GCP guidelines Country-specific clinical research regulations Knowledge of global and regional clinical research requirements.
  • Strong understanding of Good Documentation Practices (GDP).
  • Demonstrated monitoring expertise and sound professional judgment.
  • Ability to analyze data and performance metrics and take appropriate action.
  • Systems & Technology Proficiency in Microsoft Office applications.
  • Problem Solving Ability to manage complex issues and work in a solution-oriented manner.
  • Experience conducting root cause analyses and implementing corrective and preventive actions.
  • Strong risk assessment and decision-making capabilities.
  • Behavioral Competencies Excellent time management and organizational skills.
  • Strong interpersonal and communication skills.
  • Effective conflict resolution and problem-solving abilities.
  • Ability to work independently across multiple studies, sites, and therapeutic areas.
  • Strong sense of accountability, urgency, and ownership.
  • Ability to prioritize competing demands in a fast-paced environment.
  • Demonstrated success working in multicultural and matrixed organizations.
  • Strong customer-focused mindset.
  • Commitment to quality, compliance, and continuous improvement.
  • Positive attitude, growth mindset, and self-driven work ethic.
  • & Experience Bachelor's Degree or higher in a scientific or healthcare-related discipline; and Minimum 2 years of direct site management/monitoring experience within a pharmaceutical, biotechnology, or CRO environment.

Preferred

  • Proven site management and patient recruitment experience.
  • Experience using clinical systems such as CTMS, eTMF, and mobile monitoring tools.
  • Ability to quickly adopt new technologies and applications.
  • Professional presence and communication style aligned with organizational standards.

Travel

Requirements Domestic and international travel of approximately 65%–75% of working time.

Additional location(s) Compensation Information

Required Skills: Accountability, 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: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & 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.

Employee Status

Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.