IMMEDIATE NEED: Clinical Research Associate with at least 2 years of regional CRA experience.
This position is home-based with regular on-site visits.
1. Communication - Maintains timely and effective communication among team members and site staff. Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
2. Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to less complex findings without oversight and may require guidance to respond to more complex/serious findings. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.
3. Monitoring - Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits effective time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits.
4. Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
5. Reporting and Tracking - Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.6. Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.
Job Type: Full-time