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Clinical Research Associate

Keywords / Skills : BPO Services

2 - 4 years
Posted: 2019-07-21

Clinical Research Associate/Manager
Posted On
21st Jul 2019
Job Ref code
Job Description
Job Description :

Job Location: Thane

Experience Range: 2 -4 Years

Skills required - CRA knowledge, CRC knowledge, Patient Data knowledge, ICH - GCP, ICF, Adverse Events/ SAEs, site monitoring, remote site monitoring knowledge. (eTMF - experience - not mandatory but preferred).

  • Provide project related assistance for assigned complex project(s), sites and project teams.
  • Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

  • Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
  • Establish and maintain effective project/ site communications
  • Create and maintain relevant project documents
    Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
  • Participate in document management (creation, review, maintenance, storage, as applicable)

  • Good knowledge of applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines
  • Strong written and verbal communication skills including good command of English language
  • Results and detail-oriented approach to work delivery and output
  • Good problem solving skills
  • Good planning, time management and prioritization skills
  • Attention to detail and accuracy in work
  • Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Proven ability to work on multiple projects balancing competing priorities
  • Ability to coach/ mentor junior colleagues.
  • Independent Monitoring Visit experience

Key Skill(s)

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