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Clinical Research Associate I/Ii

Expired Job

Lion Biotechnologies San Carlos , CA 94070

Posted 4 months ago

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.

Specific Responsibilities

  • 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

Education and Qualifications

  • Bachelors Degree with 2+ 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

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Clinical Research Associate I/Ii

Expired Job

Lion Biotechnologies