Clinical Research Associate I
CurrentTherapeutic Areas to Date: Pediatric Glioma, Solid Tumor, SARS-CoV-2, Lymphoma, Molecularly Altered Cancer, Atopic Dermatitis, Muscular Dystrophy, Lung Fibrosis- Clinical sites’ main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial. Oversees the conduct of the trial at designated hospitals/clinics/centers ensuring the rights and safety of human subjects are protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s).- Apply working knowledge and judgment to identify and evaluate potential patient safety and data quality issues. Determine and implement appropriate follow-up action ensuring to include applicable entities/agencies. - Perform and report on-site visits and remote contacts in accordance with monitoring plan; apply judgment and knowledge to independently resolve site issues, questions and concerns.- Assess & manage regulatory documents, test article, including supply, accountability and IP destruction/return status, as well as laboratory and equipment supplies. - Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. Update site-level training requirements and attendance logs.- Actively participate in Investigator and other external or internal meetings as well as audits & regulatory inspections as required.- Upkeep consistent SDV/SDR of site-level documents, utilizing various source including EMRs.- Follow-up of CRF data entry, query status, and SAE/AE/AESI/SUSAR/PDs. - Perform site facilities assessments during trial alongside conducting on-site study-specific training.- Submission and confirmation of site-level subject/treatment payments from Sponsor to Site.