Skip to main content

You will need to login before you can apply for a job.

Clinical Research Associate II

Employer
KlinEra Global Services Inc
Location
San Jose, CA
Start date
Nov 20, 2024
View more categoriesView less categories

Job Details

Qualifications

  • Bachelor's degree in life science/related field, advanced degree preferred
  • Minimum of 2+ 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 travel to and from clinical sites and manage the demands of site visits.
  • Capacity to work with and review large volumes of documentation and data.
  • Combination of office work and travel to clinical sites, which may include healthcare environments and other clinical settings.

Responsibilities 

  • Assist in the preparation and initiation of clinical trial sites, including site qualification and initiation visits.
  • Conduct routine monitoring visits to assess site compliance with study protocols, GCP, and regulatory requirements.
  • Ensure that the site is properly conducting the study and addressing any issues or concerns that arise.
  • Review source documents and verify data against case report forms (CRFs) to ensure accuracy and completeness.
  • Identify discrepancies or issues in data entry and work with site staff to resolve them.
  • Assist in the collection and submission of essential documents and study materials.
  • Ensure that all study-related documentation is accurate, complete, and up-to-date.
  • Maintain organized records of monitoring activities, site correspondence, and study data.
  • Assist in preparing for and managing audits or inspections by regulatory agencies.
  • Serve as a point of contact for site staff, addressing questions and providing support as needed.
  • Communicate effectively with the study team, including updates on site performance and any issues encountered.
  • Provide support in the training of site staff on study protocols and procedures.
  • Assist with the preparation and review of study documents, including monitoring reports and site visit reports.
  • Support the study team in ensuring adherence to study timelines and deliverables.

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

linkedin

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

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert

Similar jobs