Job Description

We are seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join our clinical operations team. With guidance and support from the team, the CRA serves as the primary site contact and site manager throughout all phases of a clinical research study, taking ownership of assigned sites and ensuring high-quality trial execution.

The CRA will build strong site relationships, support study start-up and maintenance activities, perform remote and on-site monitoring, and help ensure that studies are conducted in compliance with applicable regulations, sponsor requirements, and protocol procedures.

Key Responsibilities:

• Act as the primary site contact and site manager for allocated sites across all phases of the clinical trial.
• Develop and maintain strong, effective site relationships to support continuity throughout the study lifecycle.
• Perform clinical study site management and monitoring activities in compliance with:ICH-GCPSponsor SOPsLocal laws and regulationsStudy protocolSite Monitoring PlanRelated study documents
• Develop a strong understanding of the study protocol and all related procedures.
• Coordinate and manage assigned tasks with internal sponsor teams to support site readiness.
• Participate in site selection and validation activities and provide input as required.
• Conduct remote and on-site monitoring and oversight activities to ensure:Data generated at site are complete, accurate, and unbiasedSubject rights, safety, and well-being are protected
• Perform site visits, including:Validation visitsSite initiation visitsMonitoring visitsClose-out visits
• Prepare clear, accurate, and timely visit reports and non-visit contact reports.
• Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
• Communicate effectively with investigators and site staff.
• Identify, assess, and resolve site performance, quality, and compliance issues, escalating as needed through the defined CRA escalation pathway in collaboration with management and key stakeholders.
• Partner with internal functions such as GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, as well as external vendors, IRB/IECs, and regulatory authorities.
• Maintain accurate study information and documentation in CTMS, eTMF, and other applicable systems within required timelines.
• Use approved systems and dashboards, maintain data quality, and apply basic automation, analytics, and approved AI tools with guidance.
• Support audit and inspection activities as needed.
• Perform co-monitoring activities where appropriate.
• Travel domestically and internationally approximately 65%–75% of working time, typically 2–3 days per week.
• A valid driver’s license is preferred.

Qualifications, Skills & Experience:

Technical Competencies:

• Fluent in local language(s) and English, both verbal and written, with excellent communication skills.
• Ability to understand technical information and, with support, present it clearly.
• Good understanding of: Clinical research; Clinical trial phases; Current GCP/ICH standards; Country-specific clinical research laws and guidelines.
• Working knowledge of global and local CRA guidelines and the ability to operate within them.
• Hands-on knowledge of Good Documentation Practices.
• Developing skills in site management, including site performance and patient recruitment.
• Developing monitoring skills and sound professional judgment.
• Strong IT proficiency, including MS Office and clinical applications on desktop, tablet, and mobile devices.
• Ability to adapt quickly to new systems and technologies.
• Uses approved systems and dashboards, maintains data quality, and applies basic automation, analytics, and approved AI with guidance.
• Strong quality and compliance mindset.
• Ability to manage complex issues with a solution-oriented approach.
• Ability to perform root cause analysis and implement corrective and preventive actions.

Behavioral Competencies

• Strong time management, organizational, interpersonal, and conflict management skills.
• Ability to work collaboratively with experienced research professionals across multiple protocols, sites, and therapy areas.
• High sense of accountability and urgency; able to prioritize and manage multiple tasks in a dynamic environment with support from line management.
• Ability to work effectively in a matrix, multicultural environment and build culturally sensitive working relationships.
• Strong customer focus.
• Positive, growth-oriented, and self-driven mindset.
• Ability to work independently while maintaining professionalism.
• Demonstrates professional demeanor and communication aligned with organizational policies and practices.

Education & Experience Requirements:

One of the following:

• Associate’s degree, certificate, or equivalent in a scientific/healthcare discipline, plus at least 3 years of relevant experience in the healthcare field.
• Bachelor’s degree or above in a scientific/healthcare discipline, plus at least 6 months of relevant experience in the healthcare field.
• Bachelor’s degree or above in a non-scientific/healthcare discipline, plus at least 2 years of relevant experience in the healthcare field.

Why Join Us?

• Opportunity to contribute to the successful delivery of clinical research studies.
• Exposure to a collaborative, multicultural, and highly regulated global environment.
• Professional growth through hands-on site management and monitoring experience.
• The chance to make a meaningful impact on clinical trial quality, compliance, and patient safety.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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