Clinical Research Associate

Clinical Research Associate
  • $90,000 - $110,000 per Hour
    HOUR
  • Permanent
  • Los Altos CA, US Los Altos SANTA CLARA US 94022
Job Ref: JO000124000
Sector: Clinical
Sub-sector: Clinical
Date Added: 07 October 2021


Clinical Trial Manager I
JOB DESCRIPTION

We are seeking an experienced Clinical Trial Manager I to successfully support in managing and execution of one or
more clinical trials/programs with some supervision: a candidate who is a hands-on who understands the fast-paced
start-up environment and can support in managing all aspects of our clinical development including handling the needs
of a Phase 3 pancreatic cancer randomized trial, upcoming Phase 2/3 bile duct cancer trial, and other upcoming
oncology trials. Being resourceful with excellent problem-solving skills is key. Must be able to help manage all clinical
operational aspects of a clinical trial/program from site selection, startup, enrollment, maintenance, and close-out. Must
be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop
SOPs, etc.
Candidates Must be Local to our Client Location in or within Commutable distance to Los Altos, CA. In-house expectation 3-4 days per week.
This position will report to the Sr. Director of Clinical Operations and Research with high potential for growth
opportunity.
Responsibilities:
Overall support in management of multi-center oncology trials conducted by the company- Responsibilities
include:

  • Become a subject matter expert on Clients' clinical trial protocols
  • Respond to questions from Study Sites regarding protocol and study conduct as they arise
  • Overseeing patient enrollment including enrollment goals and timelines
  • Overseeing data collection and monitoring
  • ?Submissions and communications to/with IRBs/ECs
  • Work with internal and external teams including, but not limited to, safety, regulatory affairs, statisticians, Data
  • Management, Imaging and others as necessary
  • Support coordination with Data Monitoring Committee/Data Safety Monitoring Board and organize regular meetings
  • Maintain Clinical Research Project status and support updates to company’s weekly meetings and to management as needed
  • Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics and timelines, and critical study activities
  • Develop and maintain enrollment
  • Help manage CROs and third-party vendors to ensure delivery against contracted scope of work and budget
  • Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management
  • Help develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings
  • Oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up)
  • Help develop study plans, including vendor oversight, risk, safety, communication
  • Help proactively identify risks, develop and implement mitigation strategies
  • Oversee other clinical studies/goals in the future as determined by the company
  • Other assignments may be added in the future

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
#LI-TR1

SRGTalent
30/11/2021 12:00:00
USD 90000.00 110000.00 Hour
Contact Consultant:
Tyler Rostad

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