Merck
Job Description
The Clinical Research Associate (CRA) is accountable for the performance and compliance of assigned clinical study protocols and investigational sites within the country. Under the oversight of the CRA Manager, the CRA ensures that study conduct complies with ICH-GCP guidelines, local regulatory requirements, sponsor policies and procedures, quality standards, and adverse event reporting requirements.
The CRA serves as the primary site contact and site manager throughout all phases of a clinical research study, assuming overall responsibility for assigned sites. The role also contributes to the development of clinical research capabilities by identifying and cultivating new investigator sites and participating as a subject matter expert (SME) in monitoring processes and systems.
Key Responsibilities
Site Management & Monitoring
Regulatory & Compliance Management
Site Performance & Issue Management
Cross-Functional Collaboration
Site Development
Travel Requirements
Core Competencies
Clinical & Technical Expertise
Systems & Technology
Problem Solving
Behavioral Competencies
Qualifications & Experience
Additional location(s) Compensation Information:
Required Skills:
Accountability, Accountability, Adaptability, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Conflict Management, Cultural Awareness, Customer Centricity, Customer-Focused, Data Analysis, Data Documentation, Data Reporting, Decision Making, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth Mindset, Matrix Management, Multitasking, Protocol Adherence {+ 6 more}
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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/30/2026
*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.