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Clinical Research Associate

Employer
KlinEra Global Services Inc
Location
Brisbane and Sydney
Start date
Nov 22, 2024
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Job Details

Qualifications 

  • Bachelor's degree in life science/related field, advanced degree preferred
  • Minimum of 3+ years in clinical research industry 
  • Solid understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial processes
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to manage multiple priorities and work effectively in a team environment
  • Fluency in Mandarin is preferred. We welcome applicants from diverse linguistic backgrounds

Responsibilities 

  • Participate in study protocol review and development
  • Assist in site selection and qualification process
  • Develop study documents such as informed consent forms (ICFs) and study manuals
  • Conduct site initiation visits (SIVs) to train site staff on study protocols and procedures
  • Verify site capabilities and ensure availability of necessary study materials
  • Assist with regulatory document collection and submission
  • Perform routine monitoring visits to clinical sites according to the monitoring plan
  • Ensure adherence to the protocol, GCP, and applicable regulatory requirements
  • Review and verify data accuracy and completeness in source documents and case report forms (CRFs)
  • Track subject recruitment and enrollment status at clinical sites
  • Ensure timely resolution of data queries and discrepancies
  • Monitor investigational product (IP) accountability and storage conditions
  • Review safety data and ensure proper documentation and reporting
  • Conduct close-out visits to ensure completeness of study documentation and data
  • Assist in the resolution of outstanding issues and data queries
  • Ensure proper archiving of study documents and materials
  • Maintain regular communication with study sites, investigators, and sponsors
  • Provide study progress updates and reports to project teams and stakeholders

Company

Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate the delivery of novel therapeutic treatments with faster patient access. As a global company, we have offices on every major continent, with our headquarters based in the heart of Silicon Valley. A significant asset is our 350 employees, reflecting our commitment to inclusivity and equity within the workplace.

KlinEra has extensive experience in a diverse number of therapeutic areas for the last two decades. A thorough understanding of specific therapeutic areas, including gastroenterology, oncology and neurology, ensures compliance and facilitates optimal delivery. Our unsurpassed network of key opinion leaders and established relationships with investigators enable expedited enrollment and quality results. To date, we've completed over 50 large-scale phase 1, 2 and 3 trials successfully by implementing complete clinical trial management, medical monitoring, data management and site management services, all utilizing high-quality protocols and Good Clinical Practices (GCP).

As a company, we strive to establish lasting values and principles, provide excellent working conditions, and give back to the community. Outside of primary business functions, KlinEra offers KlinEducate which contributes to educating the younger generation about the clinical research industry. KinEra also provides affordable medical care to over 1200 patients every month at a subsidized cost in India. KlinEra has always been committed to sustainable business practices, preserving its values, and helping the environment.

CONNECT

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Company info
Website
Phone
(408)791-0120
Location
313 Piercy Rd
San Jose
California
95138
United States

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