Job Description

The Clinical Research Associate (CRA) is accountable for the overall performance and compliance of assigned clinical trial sites and protocols within [country]. Under the oversight of the CRA Manager, you will ensure that study conduct at your sites is fully compliant with ICH/GCP, local regulations, and internal policies and procedures, including quality standards and adverse event reporting requirements.

You will act as the primary point of contact for investigators and site staff throughout all phases of the clinical study, taking operational responsibility for your allocated sites. A key part of this role is to actively develop and expand the territory for clinical research by identifying, initiating, and building relationships with new sites and contributing to their capability development.

You will also contribute as a Subject Matter Expert (SME) for monitoring processes and systems and participate in internal meetings and workstreams, sharing best practices and supporting continuous improvement.

Key Responsibilities:

Site Management & Monitoring:

• Develop and maintain strong, collaborative relationships with investigators and site staff, ensuring continuity throughout all trial phases.
• Perform all aspects of clinical site management and monitoring in accordance with ICH-GCP, Sponsor SOPs, local laws and regulations, the study protocol, Site Monitoring Plan, and related documents.
• Gain and maintain in-depth knowledge of assigned study protocols and study-specific procedures.
• Conduct on-site and remote monitoring and oversight activities, using a variety of tools and systems to ensure: Data generated at the site are complete, accurate and unbiased. The rights, safety, and well-being of trial participants are protected.
• Plan, conduct, and document site visits including, but not limited to, site validation/feasibility, initiation, routine monitoring, and close-out visits.
• Prepare clear, comprehensive, and timely visit reports and non-visit contact reports.

Study Start-Up, Maintenance & Close-Out:

• Collect, review, and track required regulatory and site documentation to support study start-up, ongoing conduct, and close-out.
• Coordinate and manage tasks with cross-functional colleagues to ensure sites achieve Site Ready status within agreed timelines.
• Participate in and provide input for site selection and validation activities.
• Manage and maintain accurate, timely information and documentation in CTMS, eTMF and other relevant systems.

Quality, Compliance & Performance Management:

• Ensure sites operate in full compliance with ICH-GCP, local regulations, and internal quality standards.
• Identify, assess, and resolve site performance, quality, or compliance issues; escalate as appropriate in line with the CRA Escalation Pathway and in collaboration with the CRA Manager, Country Research Manager (CRM), Therapeutic Area (TA) Head, and Clinical Research Director (CRD).
• Support and/or lead preparation for, and participation in, audits and inspections; conduct co-monitoring visits as required.

Cross-Functional Collaboration & Territory Development:

• Work closely with key internal stakeholders including GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, and HQ functional areas.
• Collaborate externally with vendors, IRB/IECs and regulatory authorities as needed in support of your sites.
• Contribute to the country/site strategy as defined by the CRD and/or CRA Manager, including identifying and developing new potential investigator sites and strengthening clinical research capabilities across the territory.

Knowledge Sharing & SME Responsibilities:

• Act as a process SME and actively contribute to CRA team knowledge and capability development.
• Serve as buddy/mentor to less experienced CRAs, sharing best practices and supporting their onboarding and development.
• Participate in internal meetings and working groups focusing on monitoring processes, systems, and continuous improvement initiatives.

Core Competencies & Technical Skills:

• Fluency in local language(s) and English (verbal and written), with excellent communication and presentation skills, including the ability to convey technical information clearly.
• Solid understanding of clinical research principles, clinical trial phases, and current GCP/ICH and local clinical research regulations and guidelines.
• Good understanding of global and local clinical research guidelines and the ability to work within these requirements.
• Practical knowledge of Good Documentation Practices.
• Proven skills in site management, including oversight of site performance and patient recruitment/retention strategies.
• Demonstrated high level of monitoring skills with sound, independent professional judgment.
• Strong IT skills, including proficiency with MS Office and various clinical IT applications (e.g., CTMS, eTMF, EDC) on computer, tablet, and mobile devices; ability to quickly learn and adapt to new tools.
• Ability to interpret, analyze and act on data/metrics related to site performance, quality, and timelines.
• Capable of managing complex issues in a solution-oriented manner, including performing root cause analyses and implementing corrective and preventive actions (CAPA).

Behavioral Competencies:

• Effective time management, organizational, interpersonal, conflict management and problem-solving skills.
• Ability to work highly independently across multiple protocols, sites and therapeutic areas, with minimal supervision.
• Strong sense of accountability and urgency; able to set priorities and manage multiple tasks in a dynamic environment.
• Demonstrated ability to work effectively in a matrixed, multicultural environment and maintain culturally sensitive working relationships.
• Strong customer focus and collaborative mindset.
• Consistently high quality and compliance orientation with attention to detail.
• Positive, growth-oriented mindset; self-driven, proactive, and resourceful.
• Professional demeanor and communication style aligned with organizational standards and values.

Experience & Education:

• Bachelor’s degree (or higher) in a scientific or healthcare-related discipline.
• At least 2 years of direct site management (monitoring) experience in a biopharmaceutical, pharmaceutical, or CRO environment.

What We Offer:

• Meaningful Work: The opportunity to contribute directly to clinical research that advances patient care and medical innovation.
• Professional Growth: Continuous learning opportunities, including training on new systems, processes, and therapeutic areas, as well as development programs for career progression.
• Collaborative Environment: A supportive, diverse, and multicultural team environment, working in close partnership with global and local stakeholders.
• Flexible Working: Potential for a flexible and hybrid working model (office/field/home-based) depending on country policy and business needs.
• Competitive Compensation & Benefits: Market-competitive salary and benefits package, including health and wellness programs, pension/retirement plans, and other local benefits (as per country policy).
• Tools & Resources: Access to modern digital tools and systems, and the support you need to perform your role effectively in the field and remotely.
• Recognition & Impact: Visibility with local and global clinical operations leadership, and recognition for high performance and strong contribution.

Required Skills:

Adverse Event Reporting System, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP)

Preferred Skills:

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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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

75%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Job Posting End Date:

03/8/2026

*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.