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

Job description

Job Description CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS: Illinois, Colorado, South Florida, New York, California, Houston, Dallas • 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. • Responsibilities include, but are not limited to: • 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 generated at site are complete, accurate and unbiased. • Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately 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 as appropriate in collaboration with 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 in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required. • 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. Extent of Travel: • Ability to travel domestically and internationally approximately 65%-75% of working time. • Expected travelling ~2-3 days/week. • Current driver’s license required. CORE Competency Expectations: • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. • 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 (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various 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 judgement. • 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 in a changing environment. • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. • Demonstrates commitment to Customer focus. • Works with high quality and compliance mind-set. • Positive mindset, growth mindset, capable of working independently and being self-driven. • Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience and Educational Requirements: • Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO. Or • Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.