Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote

Location Requirements The candidate must reside in one of the following locations: Illinois, Colorado, South Florida, New York, California, Houston, Dallas. Responsibilities Accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA‑Manager ensures compliance of study conduct with ICH/GCP, country regulations, company policies, quality standards and adverse event reporting requirements. 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 by finding and developing new sites. Participates in internal meetings and workstreams as subject matter expert for monitoring processes and systems. 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 and provides inputs on site selection and validation activities. Performs remote and on‑site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased; subjects’ rights, safety and well‑being are protected. Conducts site visits including validation, initiation, monitoring and close‑out visits and records clear, comprehensive and accurate visit & non‑visit contact reports in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start‑up, study maintenance and study close‑out. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway in collaboration with the CRA‑Manager, 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 with vendors and IRB/IECs and Regulatory Authorities to support assigned sites. Manages and maintains information and documentation in CTMS, eTMF and other systems as appropriate and per timelines. Contributes to CRA team knowledge as process subject matter expert, buddy/mentor and shares best practices. 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 the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Travel Requirements Approximately 65-75% domestic and international travel; expected 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 of clinical research phases, current GCP/ICH & local clinical research law & guidelines. Good understanding of global, country/regional guidelines and ability to work within them. Hands‑on knowledge of Good Documentation Practices. Proven skills in site management including management of site performance and patient recruitment. Demonstrated high level of monitoring skill with independent professional judgment. Good IT skills (MS Office, various clinical IT applications on computer, tablet and mobile devices). Ability to understand and analyze data/metrics and act appropriately. Capable of managing complex issues, works in a solution‑oriented manner. Performs root cause analysis and implements preventative and corrective action. Behavioral Competency Expectations Effective time management, organizational and interpersonal skills, conflict management, problem‑solving skills. Demonstrated high level of monitoring skill with independent professional judgment. Able to work highly independently across multiple protocols, sites and therapy areas. High sense of accountability / urgency; ability to set priorities and handle multiple tasks simultaneously. Works effectively in a matrix multicultural environment; establishes culturally sensitive working relationships. Demonstrates commitment to customer focus. Works with high quality and compliance mind‑set. Positive and growth mindset; capable of working independently and being self‑driven. Demonstrates professional demeanor and communication consistent with organizational policies and practices. Experience and Educational Requirements Associate’s degree or equivalent in a scientific/healthcare discipline with at least 5 years of relevant experience, including at least 2 years of direct site management experience in a bio‑pharma‑CRO. OR Bachelor’s degree (or above) with at least 2 years of direct site management 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 Core competencies Data analysis and reporting Early clinical development Policy development Preventive action Protocol adherence Regulatory compliance Site management Benefits & Compensation Salary range: $96,200.00 - $151,400.00. Eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive benefits package, including medical, dental, vision, healthcare insurance for employee and family, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days. For more information, visit . EEO Commitment As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. Additional Details Flexible work arrangements: Remote Eligible for relocation: No Visa sponsorship: No Valid driving license: Yes Hazardous materials: N/A Shift: Not Indicated #J-18808-Ljbffr Merck & Co.