CRA I - Immuno - Oncology Biotech

Job Reference: #43724 Add to saved jobs

  • Location San Carlos, CA
  • Permanent
  • Sector Pharmaceuticals

Job Summary

Responsible for assisting with clinical trial management and site management. Serves as support staff in activities such as protocol and informed consent preparation/finalization, reviewing of CRF and CRF guidelines, participating in ongoing clinical data review, study plans/presentations development, investigative site selection/credentialing, site contract/budget negotiations, regulatory/review board submissions/approvals and site training/initiation.

Job Overview

• Supports the set-up and on-time execution of clinical tasks, while ensuring the trial is conducted in compliance with the protocol, SOPs/Work Instructions, ICH-GCP, and applicable regulatory requirements
• Supports Clinical Trial Manager/Clinical Director in scheduling of internal and external team meetings, investigator meetings, and other trial¬ specific meetings as required
• Attends and serves as scribe for internal and external team meetings, supporting agendas, minutes and action item tracking
• Effectively tracks, files and archives study communications, contracts, essential documents, to provide a complete TMF and Sponsor records
• Collates and maintains study metrics for reporting purposes through established clinical study dashboards and trackers; with archiving of reports
• Supports risk management and mitigation through competing tasks and highlighting issues to ensure study objectives are successfully accomplished
• Responsible for the distribution and archiving of study newsletters, tracking and reporting of recruitment updates
• Assists with supporting oversight of vendors/CROs, including invoice processing
• Reviews monitoring trip reports and follow-up of action items to resolution
• May participate in site visits as needed or accompany Sponsor/CRO members for training and support purposes
• Maintains completion of required corporate training on standards, policies, work instructions by due date
• Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
• Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
• Performs other duties as assigned

Skills Required

• Bachelor’s Degree with minimum 2 years of clinical research experience
• Demonstrated experience in core and technical aspects of supporting phase 1-3 clinical trials
• Demonstrated willingness to be hands-on and perform tasks within tight turnaround time
• Excellent interpersonal and communication skills
• Success working in a fast-pace matrix environment
• In depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook, and MS Windows NT,
• Proactive, self-directed, able to thrive and adapt in a rapidly changing environment
• Able to assimilate information quickly, grasping critical factors and risks, while implementing immediate change where/when needed
• Able to build strong relationships with peers and partners both within and across functional teams to engage high performance
• Strives to create a dynamic environment, opens to suggestions and experimentation for improvement
• Embraces the ideas of others, nurtures innovation and manages goals to reality

Contact Details

Please contact Georgia Cowderoy on 628-229-9024 or email if you would like to know more about this opportunity. This will be 100% confidential.

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