Job Description
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, 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,
- 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 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,
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
RemoteShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Accountability, Accountability, Adaptability, Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Early Clinical Development, FINRA Regulations, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Key Performance Indicators (KPI), Management Process, Medical Research, Monitoring Control, Pharmaceutical Regulatory Affairs, Protocol Adherence, Quality Standards, Regulatory Affairs Compliance, Regulatory Affairs Management {+ 3 more}Preferred Skills:
Job Posting End Date:
08/31/2025- 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:R349883