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Clinical Trainee Associate

Keywords / Skills : BPO Services

1 - 1 years
Posted: 2019-07-21

Industry
ITES/BPO
Function
IT
Pharmaceutical/Biotechnology
Role
Clinical Research Associate/Manager
Clinical Project Associate/Manager
Software Engineer/ Programmer
Posted On
21st Jul 2019
Job Ref code
124688
Job Description
Job Description :

Job Location: Thane

Experience Range: 6 Months - 1 Year

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).

PURPOSE:
  • 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.


RESPONSIBILITIES :
  • 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)


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • 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

Key Skill(s)

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