Merck & Co., Inc. / Merck Sharp & Dohme LLC is hiring a Clinical Research Associate (CRA) to be accountable for the performance and compliance of assigned clinical trial protocols and sites within a country. You will act as the primary site contact and manager throughout all study phases, ensuring compliance with regulations and quality standards while actively developing new research sites.

What You'll Do

Ensure compliance of study conduct with ICH/GCP, country regulations, company policies, procedures, quality standards, and adverse event reporting requirements.
Act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites.
Actively develop and expand the territory for clinical research by finding and developing new sites.
Develop strong site relationships and ensure continuity through all trial phases.
Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, and Site Monitoring Plan.
Gain an in-depth understanding of the study protocol and related procedures.
Coordinate & manage tasks with other sponsor roles to achieve Site Ready status.
Participate & provide inputs on site selection and validation activities.
Perform remote and on-site monitoring & oversight to ensure data completeness, accuracy, and subject safety.
Conduct site visits (validation, initiation, monitoring, close-out) and record clear, comprehensive visit reports.
Collect, review, and monitor required regulatory documentation for study start-up, maintenance, and close-out.
Communicate with Investigators and site staff on protocol conduct, recruitment, retention, deviations, documentation, audits, and site performance.
Identify, assess, and resolve site performance, quality, or compliance problems, escalating as appropriate.
Work with internal functions (operations, finance, regulatory, pharmacovigilance, legal) and external parties (vendors, IRB/IECs, Regulatory Authorities).
Manage and maintain information and documentation in CTMS, eTMF, and other systems per timelines.
Contribute to CRA team knowledge as a process Subject Matter Expert (SME), buddy/mentor, sharing best practices.
Support and/or lead audit/inspection activities as needed.
Perform co-monitoring visits where appropriate.
Contribute to identifying new potential sites and developing their clinical research capabilities per country strategy.

What We're Looking For

Associate's degree, certificate or equivalent in a scientific/healthcare discipline with at least 5 years of relevant healthcare experience, including at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
OR Bachelor’s degree (or above) with at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.
Fluent in Local Languages and English (verbal and written).
Excellent communication skills, including ability to understand and present technical information effectively.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within them.
Hands on knowledge of Good Documentation Practices.
Proven Skills in Site Management including management of site performance and patient recruitment.
Demonstrated high level of monitoring skill with independent professional judgment.
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications.
Ability to understand and analyse data/metrics and act appropriately.
Capable of managing complex issues, works in a solution-oriented manner.
Performs root cause analysis and implements preventative and corrective action.
Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
Able to work highly independently across multiple protocols, sites and therapy areas.
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus.
Works with high quality and compliance mind-set.
Positive mindset, growth mindset, capable of working independently and being self-driven.
Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.

Technical Stack

CTMS
eTMF
MS Office
Clinical IT applications

Team & Environment

You will work under oversight of a CRA-Manager. The role involves collaboration in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, as well as HQ functional areas.