Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- R
Job Description
CANDIDATE MUST RESIDE IN ONE OF THE FOLLOWING LOCATIONS:
Illinois, Colorado, South Florida, New York, California, Houston, Dallas
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The role is accountable for performance and compliance for assigned protocols and sites in a country.
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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.
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Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
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Actively develops and expands the territory for clinical research, finding and developing new sites.
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Participates in internal meetings and workstreams as SME for monitoring processes and
- Systems.
Responsibilities include, but are not limited to:
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Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
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Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
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Gains an in-depth understanding of the study protocol and related procedures.
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Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
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Participates & provides inputs on site selection and validation activities.
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Performs remote and on-site monitoring & oversight activities using various tools to ensure:
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Data generated at site are complete, accurate and unbiased.
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Subjects’ right, safety and well-being are protected.
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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.
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Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
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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.
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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.
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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.
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Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
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Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
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Supports and/or leads audit/inspection activities as needed.
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Performs co-monitoring visits where appropriate.
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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:
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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:
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Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
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Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
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Good understanding of Global, Country/Regional Clinical Resear