Clinical Research Associate (CRA) - Immunology-Remote

Job Description The role is accountable for the performance and compliance of assigned protocols and sites in a country. Under the oversight of the CRA-Manager, the person ensures compliance of study conduct with ICH/GCP, country regulations, company policies, quality standards, and adverse event reporting requirements. They act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites and actively developing new sites in the territory. Locations Texas Illinois Arizona Florida California New York Colorado Responsibilities 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, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. 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 data quality and patient safety. Conducts site visits (including validation, initiation, monitoring, close‑out) and records clear, comprehensive, and timely visit and non‑visit contact reports. Collects, reviews, and monitors required regulatory documentation for study start‑up, maintenance, and close‑out. Communicates with Investigators and site staff on protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and overall site performance. Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per CRA Escalation Pathway with CRA‑Manager, CRM, TA Head, and CRD as needed. Works collaboratively with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functions, vendors, IRB/IECs, and regulatory authorities to support assigned sites. Manages and maintains information and documentation in CTMS, eTMF, and other relevant systems per timelines. Contributes to CRA team knowledge as a process SME, buddy/mentor, and shares best practices. Supports and/or leads audit/inspection activities as needed. Performs co‑monitoring visits where appropriate. Contributes to the identification of new potential sites under country strategy and develops strong clinical research capabilities. Extent Of Travel Ability to travel domestically and internationally approximately 65%–75% of working time. Expected travelling ~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. Good understanding and working knowledge of clinical research, phases, and GCP/ICH & country guidelines. Hands‑on knowledge of Good Documentation Practices. Proven skills in site management, including performance and patient recruitment. High level of monitoring skill with independent professional judgement. Strong IT skills (MS Office, various clinical IT applications on computer, tablet, and mobile). Ability to understand and analyze data/metrics and act appropriately. Capability to manage complex issues and work solution‑oriented. Performs root‑cause analysis and implements preventative and corrective action. Behavioral Competency Expectations Effective time management, organization, interpersonal, conflict management, and problem‑solving skills. Works highly independently across multiple protocols, sites, and therapy areas. High sense of accountability/urgency and priority setting. Works effectively in a matrix multicultural environment and establishes culturally sensitive relationships. Customer‑focused with high quality and compliance mindset. Positive and growth mindset, capable of working independently and being self‑driven. 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 5 years of relevant experience, including 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. OR Bachelor’s degree (or above) with at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Required Skills Adverse Event Reporting System Clinical Research Methods Clinical Site Management Clinical Study Management Clinical Trial Planning Clinical Trials Monitoring Early Clinical Development Policy Development Preventive Action Protocol Adherence Regulatory Affairs Compliance Regulatory Compliance Site Management Training Team Members Benefits Salary range: $96,200.00 – $151,400.00. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits package includes medical, dental, vision, other insurance (for employee and family), retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. EEO Statement We are an Equal Employment Opportunity Employer. All employees and applicants are eligible for 1‑year holidays and sick leaves as well as 1‑year. Our organization is committed to inclusion, ensuring that candidates can engage in a hiring process that reflects their true capabilities. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement. Please note that year we advance with California, Colorado and other U.S. state acts. #J-18808-Ljbffr Merck