Senior Clinical Research Associate - Organ Transplantation

6 days ago

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Description

• Serves as an expert in Clinical Monitoring activities and processes • Work with monitoring team members and cross functional project team members • Responsible for field and off-site monitoring activities for oversight of a clinical trial • Build effective site relationships • Ensure that the rights and well-being of study subjects are protected • Drive data cleaning efforts with Investigative Sites in preparation for study interim analysis and database lock • Provide advanced level support to the study team in preparation for audits/inspections

Requirements

• Bachelor’s Degree preferably in a health, biological sciences, or related field or Registered Nurse (RN) nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industry may be considered • 8+ years of relevant pharmaceutical industry experience • 5+ years of direct clinical research associate experience • Working knowledge and understanding of the clinical trial process; including ICH-GCPs, FDA regulations and familiarity with global regulatory bodies • Proficient in performing all clinical trial tasks required of a CRA • Experience in all stages of a clinical trial (start-up, maintenance, and close-out) • Experience with development of clinical monitoring plan (CMP) • Proficient with File/Document Management Platforms such as PlexGlobal, WingSpan, Veeva and Signature Software such as Adobe Acrobat and DocuSign • EDC platforms such as Medidata RAVE, Oracle InForm, Medrio, Veeva EDC • Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint) • Experience with communication systems such as Microsoft Teams, WebEx, GoToMeeting • Attention to detail and accuracy of work • Good communication skills, written and verbal • Excellent interpersonal and customer service skills • Creative problem solving • Ability to work independently and as part of a cross-functional team • Effective time management and organizational skills • Ability to multi-task in a demanding and rapidly changing environment • Ability to work a flexible work week; inclusive of evenings and/or weekends

Benefits

• medical / dental / vision / prescription coverage • employee wellness resources • savings plans (401k and ESPP) • paid time off & paid parental leave benefits • disability benefits • more.