Job Description
Specialist, Clinical Research Associate
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:
o Data generated at site are complete, accurate and unbiased.
o 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, Adaptability, Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Protocol Adherence, Regulatory Compliance, Training Team Members
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:
05/30/2026
*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.
