Sr. Clinical Research Associate (CRA)- Early Stage Development (ESD) Remote

CANDIDATE MUST RESIDE IN FLORIDA.

Early Stage Development Experience Required. The role is accountable for performance and compliance for assigned protocols and sites in a country, ensuring compliance with ICH/GCP, sponsor SOPs, local regulations, and company policies. Responsibilities Develop strong site relationships and ensure continuity of site relationships through all phases of the trial. Perform site management/monitoring activities in compliance with ICH‑GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gain an in‑depth understanding of the study protocol and related procedures. Coordinate & manage various tasks in collaboration with other sponsor roles to achieve site readiness. Participate & provide inputs on site selection and validation activities. Conduct remote and on‑site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased and subjects’ rights, safety and well‑being are protected. Conduct site visits—including validation, initiation, monitoring, and close‑out visits—and record comprehensive 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, deviations, regulatory documentation, audits/inspections and overall performance. Identify, assess and resolve site performance, quality or compliance problems and, when appropriate, elevate per CRA Escalation Pathway in collaboration with CRA‑Manager, CRM, TA Head and CRD. Collaborate with internal GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and external vendors, IRBs/IECs and regulatory authorities. Manage and maintain information and documentation in CTMS, eTMF and related systems per timelines. Contribute to CRA team knowledge as a process subject‑matter expert, sharing best practices, recommending improvements and providing training. Support or lead audit/inspection activities as needed. Assist in the identification and development of new potential sites, working closely with them to build strong clinical research capabilities. Mentor or buddy junior CRAs on process/study requirements and perform co‑monitoring visits where appropriate. Perform quality control visits if delegated and trained accordingly. Core Competency Expectations Fluent in local languages and English; excellent communication skills. In‑depth understanding of clinical research phases, GCP/ICH and country guidelines. Strong mentoring and leadership ability. Hands‑on knowledge of Good Documentation Practices. Proven site management skills, including site performance and patient recruitment. High monitoring skill with independent professional judgment. Proficient in MS Office and various clinical IT applications on desktop, tablet and mobile. Analytical capability to assess data/metrics and act appropriately, even virtually. Experience conducting site motivational visits to boost enrollment. Ability to manage complex issues and perform root‑cause analysis with corrective/preventative actions. Behavioral Competency Expectations Effective time management, organization and interpersonal skills, conflict management, problem solving. High level of independence across multiple protocols and sites. Sense of accountability/urgency; ability to set priorities and handle multiple tasks simultaneously. Effective in a matrix multicultural environment; establishes culturally sensitive relationships. Customer‑focused and quality‑and‑compliance oriented. Positive growth mindset, self‑driven and professional demeanor. Experience & Educational Requirements Associate’s degree, certificate or equivalent in a scientific/healthcare discipline with at least 7 years of relevant experience, including 4 years of direct site management (monitoring) experience in bio/pharma/CRO; Early Stage Development experience required. or Bachelor's degree or above with at least 4 years of direct site management experience in bio/pharma/CRO; Early Stage Development experience required. Required Skills Adverse Event Report, Biopharmaceutics, Clinical Data Management, Clinical Development, Clinical Research, Clinical Study Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Customer‑Focused, Early Clinical Development, Preventive Action, Regulatory Affairs Compliance, Site Management. Preferred Skills Current employees or contingent workers who may apply as per internal processes. Travel Requirements Domestic and international travel approximately 65–75% of working time. Expected to travel 2–3 days per week. Current driver’s license required. Salary $129,000.00 – $203,100.00 Benefits Medical, dental, vision healthcare and other insurance benefits (employee and family), retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days. For more information visit Merck Compensation & Benefits . EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities for 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 any other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements. For information on personal rights visit the EEOC website. Position Availability Position available until 07/16/2026. #J-18808-Ljbffr Merck