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Senior Clinical Research Associate

Company: JGB BioPharma Consulitng Inc.
Location: San Mateo
Posted on: January 16, 2019

Job Description:

Requirements: Bachelors degree and 4+ years in pharmaceutical clinical operations Experience managing or mentoring staff, interns, or consultants preferred Description: Focus and be responsible for a specific region of a global study in terms of study start-up planning (region specific study manuals, protocols, informed consent etc.) Identify regional CLO risks and mitigations and share with the Study Lead Identify, resolve or, if necessary, escalate regional CLO issues that have a significant impact to overall global CLO study timelines, other functions, budget or quality to the lead as per study team / project team charter Lead CLO regional study activity timeline development and contribute to regional study budget development and management Provide regional/local operational and regulation knowledge to study lead as related to the studies in support of enrollment strategies Provide regional study status updates to Study Lead Contribute to regional vendor evaluation and selection process Oversee day-to-day regional CRO and vendors contracted activities as per regional oversight plans Work with COA to ensure final payments to regional vendors at study closure Responsible for all region-specific study conduct activities, including: Lead site identification, qualification, selection and activation activities for the study, such as site and staff training, site budgets, site or country specific ICF and site investigator contracts Plan and deliver IM in collaboration with other key stakeholders Ensure adherence to study enrollment strategy and plan Ensure adherence to monitoring plan Ensure adherence to monitoring oversight SOP Ensure timely site payments Partner with Patient Advocacy to manage patient travel, housing and associated patient management costs as applicable for the study Oversee all study closure activities (sites, reconciliation activities, filing & archiving, and e/TMF related activities)Coordinate and oversee data listing reviews Ensure timely uploading of clinical documents for the CSR appendices Train and mentor junior regional team members such as CRAs and CTAs Prepare regional standard metrics (KPIs, SQMs) for global study dashboards to routinely monitor team activities and ensure compliance to timelines, quality and budget Provide forecast for regional clinical supply, including ancillary supplies and comparator drugs Ensure compliance with regional regulations, GCP, and SOPs during the execution of the study Contribute expertise to departmental and cross-functional process improvement activities

Keywords: JGB BioPharma Consulitng Inc., Fremont , Senior Clinical Research Associate, Healthcare , San Mateo, California

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