Senior Clinical Research Associate

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.

Responsibilities include :

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

Qualifications required :

- 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:

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
10/1/2026
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