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Clinical Research Associate

Mountain View, CA 94043

Posted: 03/05/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 600915 Is job remote?: No Country: United States

Job Description

Our client is seeking an experienced local (SF Bay Area) part-time contract CRA  to conduct the clinical monitoring and site management for a first-in-human-phase 1-1b global clinical trial in the autoimmune therapeutic area with the possibility of expanding into oncology. The ideal candidate will be responsible for the day-to-day activities of a Clinical Research Associate (CRA), including set up, monitoring, and completion of clinical trials per SOPs, ICH-GCP, and relevant local and international regulatory guidelines with minimal supervision. Experience in monitoring Phase 1 – 2 clinical trials autoimmune space is required, as well as prior experience in certain aspects of study and site management, such as study start-up activities, patient enrollment initiatives, and study close-out. Must also be attentive to detail and able to contribute to informed consent forms, study manuals, clinical monitoring plans, and trial master file development and review. Qualifications
  • Minimum of 5 years experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry
  • Bachelor’s degree or equivalent is required.
  • Mandatory Phase I – II experience in autoimmune or oncology therapeutic areas (autoimmune preferred)
  • Comprehensive knowledge of ICH-GCP and applicable local and international regulatory guidelines.
  • Exemplary communication skills in all forms in a cross-functional collaborative manner are required
  • Competent with specific computer applications, including Microsoft Office, SharePoint, CTMS, eTMF, and EDC systems required
  • Must have strong interpersonal and collaboration skills.
  • Have a high degree of accuracy and attention to detail.
  • Preference is given to applicants locally based in the San Francisco Bay Area.
  • Regular SF Bay Area site visits required.
Responsibilities
  • Ensure the rights, safety, and well-being of clinical trial subjects are maintained.
  • Ensure site compliance with trial protocols, ICH-GCP, and applicable regulations.
  • Performs site monitoring activities, including pre-study site visits, site initiation visits, on-site monitoring visits, remote monitoring visits (as needed), and site close-out visits.
  • Establish and maintain regular contact with Investigators, vendors, and trial sites to ensure compliance with applicable regulations and the protocol.
  • Provide training of clinical trial study staff at site initiation on all study procedures and throughout the study as required.
  • Review adverse events reports and ensure the site reports the events appropriately and promptly.
  • Prepare and review study documentation (e.g., CMP, CRF completion guidelines, Protocol, pharmacy manuals).
  • Perform routine on-site interim monitoring visits, including source data verification of CRFs, query resolution, essential document maintenance, review of patient source documentation, and IMP accountability as required per protocol. Ensures accuracy of data via source data review (SDR), source data verification (SDV), and case report form (CRF) review through on-site or remote monitoring activities.
  • Review and confirm pharmacy records, ensuring data accuracy regarding proper storage, preparation, dispensation, accountability, receipt, and return of investigational products.
  • Oversee and ensure all study supplies are arranged and available on-site (e.g., laboratory support, equipment).
  • Escalate issues and deficiencies to the Clinical Trial Manager (CTM) promptly and follow through with issues to resolution.
  • Provide trial status tracking and progress update reports to the IGM Clinical Trial Manager as required.
  • Communicate project-specific information to and from trial sites and document communication with the study site/project team.
  • Perform ongoing essential document and on-site file review.
  • Ensure trial close-out and retrieval of trial materials.
  • Update study systems accordingly and on time as needed (e.g., Clinical Trial Management System, CTMS).
  • Generate QC reports from study systems as needed.
  • Coordinate and assist study site payments where required.
  • Document site and protocol adherence and observations in reports and letters in a time-sensitive manner, including the development and implementation oversight of written site corrective and preventative action (SCAPA) plans.
  • Perform additional tasks as assigned by CTM as needed.
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