Job Description Senior Clinical Research Associate (Sr. CRA)

The Senior Clinical Research Associate is responsible for the performance, quality, and compliance of assigned clinical trial sites and protocols within the country. Acting as the primary point of contact for investigators and site staff, the Sr. CRA oversees site activities throughout the study lifecycle, ensuring adherence to ICH-GCP, local regulations, and company standards. The role collaborates closely with cross-functional teams and external stakeholders to support successful study execution while driving site performance, recruitment, and operational excellence. The Sr. CRA also serves as a subject matter expert, sharing best practices, supporting audits and inspections, mentoring junior CRAs, and identifying new site opportunities to strengthen clinical research capabilities.

Responsibilities

- Site selection
- start-up
- monitoring
- regulatory document management
- issue resolution
- data quality oversight
- patient safety protection
- site close-out activities

Qualifications

- Candidates must hold a Bachelor’s degree (or higher) and;
- Have at least 4 years of direct site management (monitoring) experience in a pharmaceutical, biotechnology, or CRO environment.
- Strong communication, problem-solving, and organizational skills are essential, along with the ability to work independently in a dynamic environment.
- Domestic and international travel of up to 65-75% may be required

Required Skills

- Accountability
- Accountability
- Adaptability
- Adverse Event Report
- Clinical Data Management
- Clinical Development
- Clinical Reporting
- Clinical Research
- Clinical Research Organizations (CRO) Management
- Clinical Study Management
- Clinical Trial Compliance
- Clinical Trial Development
- Clinical Trial Documentation




- Clinical Trial Management
- Clinical Trial Planning
- Clinical Trials Monitoring
- Customer Auditing
- Customer-Focused
- Drug Development
- Good Clinical Data Management Practice (GCDMP)
- Good Clinical Practice (GCP)
- Government Regulation
- Industry Regulation
- Legal Compliance
- Liaison Work {+ 9 more}

Preferred Skills

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: Adaptable Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/1/2026 *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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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📌 Senior Clinical Research Associate (Santiago)
🏢 MSD Malaysia
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