Senior Clinical Research Associate

Job description

Job Description This role is accountable for the performance and compliance of assigned clinical trial protocols and sites within the country. Under the oversight of the CRA Manager or Clinical Research Director (CRD), the incumbent ensures that study conduct complies with ICH/GCP guidelines, country regulations, company policies and procedures, quality standards, and adverse event reporting requirements. The role serves as the primary site contact and site manager throughout all phases of a clinical research study, assuming overall responsibility for assigned sites. The incumbent will also contribute to expanding the local clinical research footprint by identifying and developing new research sites and participating as a Subject Matter Expert (SME) in monitoring processes and systems. Key Responsibilities Site Management & Monitoring Develop and maintain strong relationships with investigators and study sites throughout all phases of the clinical trial. Perform site management and monitoring activities in compliance with: ICH-GCP guidelines Sponsor SOPs Local laws and regulations Study protocol Site Monitoring Plan Associated study documents Gain a thorough understanding of study protocols and related procedures. Coordinate and manage study start-up activities in collaboration with cross-functional stakeholders to achieve Site Ready status. Participate in site identification, selection, feasibility, and validation activities. Conduct remote and on-site monitoring activities to ensure: Data generated by sites are complete, accurate, and unbiased. Participant rights, safety, and well-being are protected. Conduct site visits, including: Site validation visits Site initiation visits (SIVs) Routine monitoring visits Close-out visits Prepare clear, comprehensive, and timely visit reports and non-visit contact documentation. Regulatory & Documentation Management Collect, review, and oversee required regulatory documentation for: Study start-up Study maintenance Study close-out Ensure regulatory documents are complete, accurate, and maintained in accordance with applicable requirements. Maintain study information and documentation in: Clinical Trial Management System (CTMS) Electronic Trial Master File (eTMF) Other relevant clinical systems Site Performance, Quality & Compliance Communicate with investigators and site personnel regarding: Protocol conduct Patient recruitment and retention Protocol deviations Regulatory requirements Site audits and inspections Overall site performance Identify, assess, and resolve site performance, quality, and compliance issues. Escalate significant issues through the established escalation pathway when appropriate. Support and/or lead audit and inspection activities. Perform quality control visits when delegated and appropriately trained. Cross-Functional Collaboration Partner with internal stakeholders, including: Country Clinical Operations Finance Regulatory Affairs Pharmacovigilance Legal Regional Operations Global Functional Teams Collaborate with external stakeholders such as: Investigators Site staff Vendors Ethics Committees (IRBs/IECs) Regulatory Authorities Clinical Research Site Development Support country clinical research strategies by identifying and developing new potential research sites. Work closely with investigators and site staff to enhance site capabilities and foster long-term partnerships. Contribute to the growth of the local clinical research network and trial delivery capacity. Knowledge Sharing & Mentorship Act as a Subject Matter Expert (SME) for clinical monitoring processes and systems. Share best practices and recommend continuous process improvements. Provide training and guidance to team members as required. Mentor and support junior Clinical Research Associates through: Buddy programs Coaching Co-monitoring visits Key Success Factors Strong knowledge of ICH-GCP, local regulations, and clinical trial processes. Ability to independently manage multiple sites and priorities. Strong communication and stakeholder management skills. Excellent problem-solving and risk assessment capabilities. Commitment to quality, compliance, and patient safety. Ability to work effectively in a cross-functional and global environment. Required Skills: Accountability, Adaptability, Adverse Event Report, Biopharmaceutical Industry, Clinical Data Management, Clinical Development, Clinical Research, Clinical Research Organizations (CRO) Management, Clinical Site Management, Clinical Site Monitoring, Clinical Study Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Customer-Focused, Good Clinical Data Management Practice (GCDMP), Medical Research, Patient Recruitment, Pharmacokinetics, Pharmacotherapeutics, Pharmacovigilance, Regulatory Documents, Task Management 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: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/6/2026 *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.