Job Description

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, 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. Location Requirements Candidate must reside in one of the following locations: New York, New Jersey, Texas, Chicago, Southern California, Missouri. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Responsibilities Develop strong site relationships and ensure continuity through all phases of the trial. Perform clinical study site management/monitoring activities in compliance with ICH‑GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan and associated documents. Gain an in-depth understanding of the study protocol and related procedures. Coordinate and manage various tasks with other sponsor roles to achieve site readiness. Participate and provide inputs on site selection and validation activities. Perform remote and on‑site monitoring and oversight using various tools to ensure data at site are complete, accurate and unbiased and that subjects’ rights, safety and well‑being are protected. Conduct site visits (validation, initiation, monitoring, close‑out) and record clear, comprehensive and accurate visit & non‑visit contact reports in a timely manner. Collect, review and monitor required regulatory documentation for study start‑up, maintenance and close‑out. Communicate with investigators and site staff on protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Identify, assess and resolve site performance, quality or compliance problems and elevate per the CRA escalation pathway in collaboration with CRA‑Manager, CRM, TA Head and CRD as needed. Work collaboratively with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functional areas and external vendors, IRB/IECs and regulatory authorities. Manage and maintain information and documentation in CTMS, eTMF and other systems per timelines. Contribute to CRA team knowledge as a process SME, mentor and share best practices. Support and/or lead audit/inspection activities as needed. Perform co‑monitoring visits when appropriate. Contribute to identification of new potential sites following the country strategy defined by CRD and/or CRA‑Manager. Travel Requirements Ability to travel domestically and internationally approximately 65%–75% of working time. Expected to travel 2–3 days per week. Current driver’s license required. Core Competency Expectations Fluent in local languages and English (verbal and written) with excellent communication skills. Understanding of clinical research phases, current GCP/ICH and country guidelines. Knowledge of global, country/regional clinical research guidelines and ability to work within them. Hands‑on knowledge of good documentation practices. Proven skills in site management, site performance and patient recruitment. High level of monitoring skill with independent professional judgment. IT proficiency (MS Office, clinical IT applications across devices). Ability to analyze data/metrics and act accordingly. Complex issue management with a solution‑oriented approach. Root cause analysis and implementation of preventive and corrective actions. Behavioral Competency Expectations Effective time management, organizational and interpersonal skills, conflict management, and problem‑solving skills. Independent work across multiple protocols, sites and therapy areas. High sense of accountability and urgency; ability to prioritize and handle multiple tasks in a changing environment. Effective cross‑cultural teamwork and culturally sensitive relationships. Commitment to customer focus, high quality and compliance mindset. Positive growth mindset; self‑driven independence. Professional demeanor and communication consistent with organizational policies. Experience and Educational Requirements Associate’s degree, certificate or equivalent in a scientific/healthcare discipline with at least five years of relevant experience, including at least two years of direct site management (monitoring) experience in a bio/pharma/CRO environment. OR Bachelor’s degree or higher with at least two years of direct site management (monitoring) experience in a bio/pharma/CRO. Compensation and Benefits Salary range: $96,200.00 – $151,400.00. Salary determination is based on education, qualifications, certifications, experience, geographic location, governmental requirements and business needs. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits package includes medical, dental, vision, and other insurance benefits for employees and families; retirement benefits including 401(k); paid holidays, vacation, and compassionate and sick days. More information about benefits: Equal Employment Opportunity Merck & Co. is an Equal Employment Opportunity Employer. We provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. EEOC Know Your Rights. EEOC GINA Supplement. Learn more about your rights, including under California, Colorado and other U.S. State Acts. Other Employment Details Employee status: Regular. Relocation: No relocation. Visa sponsorship: No. Flexible work arrangements: Remote. Valid driving license: Yes. Job posting end date: 07/16/2026. #J-18808-Ljbffr

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