Specialist, Clinical Research Associate

Job Description

R405034 Specialist, Clinical Research Associate

The role is accountable for performance and compliance for assigned protocols and sites in a

country. Under the oversight of the CRA-Manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research, finding and developing new

sites.

Participates in internal meetings and workstreams as SME for monitoring processes and

systems.

Responsibilities include, but are not limited to

• Develops strong site relationships and ensures continuity of site relationships through all
  
  

phases of the trial.

• Performs clinical study site management/monitoring activities in compliance with ICH-GCP,
  
  

Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated

documents.

• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve
  
  

Site Ready.

• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure
• Data generated at site are complete, accurate and unbiased.
• Subjects right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring
  
  

visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact

reports appropriately in a timely manner.

• Collects, reviews, and monitors required regulatory documentation for study start-up, study
  
  

maintenance and study close-out.

• Communicates with Investigators and site staff on issues related to protocol conduct,
  
  

recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections

and overall site performance.

• Identifies, assesses and resolves site performance, quality or compliance problems and
  
  

escalates per defined CRA Escalation Pathway as appropriate in collaboration with

CRA-Manager, CRM, TA Head and CRD as needed.

• Works in partnership with GCTO country operations, finance, regulatory affairs,
  
  

pharmacovigilance, legal and regional operations, HQ functional areas and externally with

vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.

• Manages and maintains information and documentation in CTMS, eTMF and various other
  
  

systems as appropriate and per timelines.

• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME),
  
  

buddy/mentor and sharing best practices as appropriate/required.

• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA-Manager, contributes to the
  
  

identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Required Skills

Accountability, Accountability, Adaptability, Adverse Event Reporting System, Business Activity Monitoring, Clinical Development, Clinical Reporting, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Monitoring, Data Reporting, Document Management, Electronic Trial Master File, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Meeting Facilitation, On Site Management, Protocol Adherence, Protocol Development, Protocol Review + 7 more

Preferred Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

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

Not Applicable

Shift

Valid Driving License

Hazardous Material(s)

Job Posting End Date

10/14/2026

• 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.
  
  

Requisition ID R419942