Research Analyst

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP)
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• Supports subject/patient recruitment, retention and awareness strategies
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met

Clinical Research Associate – Full-Service

• Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators)
• Acts as the primary liaison between BD and the investigational site
• Perform all types of monitoring visits (i.e., on-site, virtual/remote, in-house) including Pre-Study (Qualification), Site Initiation, Interim, and Close-Out, according to plan
• Conducts source document verification per plan
• Routinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP/ISO, IRB/EC policies and procedures
• Site interactions involve prioritization of subject safety including appropriately administered informed consent
• Review/report AE/SAEs and protocol deviations per industry and BD standards
• Maintain audit-ready regulatory files for assigned site(s)/project(s) that align with company and industry parameters
• Maintain all project supporting systems, e.g. CTMS, EDC, eTMF, etc
• Produce proficient and timely documentation of monitoring activities/visits (e.g., timely and complete trip reports, contact records, etc. within company-specified quality standards)
• Collaborate with the studies cross-functional team members and actively participate in meetings
• Assist in development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc.
• Make sure site staff are adequately trained in all project-related requirements and tasks
• Support audit activities, as appropriate
• Ensure site(s) maintains an acceptable inventory of clinical supplies and associated documentation

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Clinical Research Associate – Full-Service

Senior Clinical Research Associate