Clinical Research Associate (90909)

Overview

As a clinical research associates (CRAs) you are responsible for completing clinical research and administrative tasks for their clients. They are in charge of facilitating documentation for clinical research as well. As a CRAs monitor clinical tasks for correct functioning and completion, evaluate clinical data, and create reports based on findings.

Responsibilities

  • Develop and write trial protocols (outlining purpose and methodology)
  • Present trial protocols to a steering committee
  • Design data collection forms, known as case report forms (CRFs)
  • Coordinate with the ethics committee, which safeguards the rights, safety and well being of all trial subjects
  • Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
  • Identify and assess the suitability of facilities to use as the clinical trial site
  • Identify/select an investigator who will be responsible for conducting the trial at the trial site
  • Liaise with doctors, consultants or investigators on conducting the trial
  • Set up the trial sites – ensuring each centre has the trial materials, including the trial drug often known as the investigation medicinal product (IMP)
  • Train the site staff to trial-specific industry standards
  • Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
  • Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
  • Collect completed CRFs from hospitals and general practices
  • Write visit reports and file and collate trial documentation and reports
  • Meet with team members to discuss on-going trials, results and any trends or adverse events
  • Ensure all unused trial supplies are accounted for
  • Close down trial sites on completion of the trial
  • Discuss results with a medical statistician, who writes technical trial reports
  • Archive study documentation and correspondence
  • Prepare final reports and occasionally manuscripts for publication.

Qualifications

University degree in scientific discipline or health care
2-3 years Experience in Healthcare Industry, and/or Clinical Trials environment preferred
Very good computer skills including MS Office
Organisational, time management and problem-solving skills
Ability to establish and maintain effective working relationships with co-workers, managers, and clients

Organization

Taskimpetus Inc.

Industry

Healthcare

Benefits

  • Increment would be at least a minimum of 15% every six months.
  • Relocation charges will be provided to you during your project
  • Medicinal, Dental and Vision benefits following 60 days of business.
  • Medical coverage qualified following 60 days of business.
  • Present moment and long-haul handicap following 60 days of work.
  • 401k retirement benefits plan qualified following half a year of work.

Only for international candidates on OPT/CPT:

  • Employer’s Confirmation Letter/CPT Letter/Offer Letter will be provided, which you need to submit to your university within 90 days of the start of your OPT.
  • OPT Extension Letter will be provided to those candidates who are qualified for STEM extension.
  • H1B Sponsorship will be provided to OPT and CPT candidates only once they join our client’s project.

Other Benefits:

  • Pre-job Training with Experienced Trainers.
  • Assignments & Case Studies provided during training.
  • Mock sessions before interviews
  • Multiple interview rounds with different clients.
  • Visa Sponsorship
  • Training completing certificates
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