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