Job Description
The role is accountable for performance and compliance for assigned protocols and sites in acountry.
Under the oversight of the CRA manager the person ensures compliance of study conduct withICH/GCP and country regulations, our company policies and procedures, quality standards andadverse 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 newsites.
Participates in internal meetings and workstreams as SME for monitoring processes andsystems.
Responsibilities include, but are not limited to:
• Develops strong site relationships and ensures continuity of site relationships through allphases 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 associateddocuments.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieveSite 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, monitoringvisits, close-out visits and records clear, comprehensive and accurate visit & non-visit contactreports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, studymaintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct,recruitment, retention, protocol deviations, regulatory documentation, site audits/inspectionsand overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems andescalates per defined CRA Escalation Pathway as appropriate in collaboration with CRAManager, 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 withvendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various othersystems 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 theidentification of new potential sites and works closely with them to develop strong clinical
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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:
Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date:
07/3/2024*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. Job Posting End Date: 07/03/2024
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: R296415
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