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18 November 2019
Job ID: BK-157531
Clinical Research Associate / Senior Clinical Research Associate

Job Purpose:

Clinical Research Associate

To provide oversight of the study conduct activities at the investigator site level for clinical trials, ensuring patient safety and data integrity. This will include site development & training, site set-up and initiation, site monitoring, and site close-out activities for specific clinical trial investigator sites. This is completed in accordance with regulatory requirements, GSK operating standards, and good clinical practices.

Senior Clinical Research Associate

In addition to the basic monitoring duties of a CRA (ensuring data integrity and patient safety at a site level), the Senior CRA will contribute over and above their role to the wider business – taking on leadership roles to represent monitoring interests within the study team , as well as taking on coaching roles and ensuring the adoption of best practices within the global monitoring organization.

Key Responsibilities:

Clinical Research Associate

  • To perform site evaluations and provide recommendations on site selection, study initiation, data monitoring and collection, patient recruitment and retention evaluation and site close-out activities for assigned sites. Assist sites and the study team during audits/inspections. On-site visits may require up to 70% travel.
  • Partner with Study Management and other relevant stakeholders to ensure optimal study conduct at assigned investigator sites in order to deliver on study objectives.
  • Proactively manage the Trial Master File and Country File to required SOP and regulatory standards. Ensure compliance with inspection readiness requirements.
  • Cultivate and maintain strong working relationships and communication with investigators, sites and GSK personnel.
  • Identify, escalate and resolve all monitoring and regulatory issues in partnership with investigator, site personnel and study teams.
  • Play a role in the development and implementation of efficient and effective approaches to study site management characterized by process standardization, best practice sharing and continuous improvement.
  • Proven ability to function independently in a matrix environment

Senior Clinical Research Associate

In addition to the basic duties described above:

  • Provide leadership in representing monitoring interests to the study conduct team.
  • Provide leadership in resolving complex monitoring and regulatory issues through discussion with Monitoring staff, project staff, or other GSK departments, as appropriate
  • Take a leadership role in developing monitoring organization characterized by process standardization, best practice sharing, and continuous improvement
  • Provide training for new monitoring personnel and contribute to their performance appraisals, as appropriate
  • • Individual contributor who demonstrates diligent and self-motivated approach to working in an off-site
  • and independent work environment

Qualification:

  • Bachelor's degree in scientific discipline.
  • Minimum of 1+ years of on-site monitoring experience; combination of education, training and experience.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
  • Strong written and verbal communication skills including good command of English language
  • Effective time management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Strong organizational and problem-solving skills

GlaxoSmithKline (Thailand) Ltd. 

Human Resources Department
12th floor, Wave Place, 
55 Wireless Rd., Lumpini, 
Patumwan, BKK 10330

Only short-listed candidates will be notified

Visit us at : http://www.gsk.com/

Apply Now

Job Details:

Benefits:
  • Five-day work week
  • Performance bonus
  • Medical insurance
  • Life insurance

GlaxoSmithKline (Thailand) Limited
https://www.gsk.com/en-gb/

GlaxoSmithKline, better known as GSK, is headquartered in the United Kingdom and is listed on the London and New York stock exchanges. We are a science-led global healthcare company that researches and develop a broad range of innovative medicines and brand. The company’s three primary areas of business are pharmaceuticals, vaccines and consumer healthcare. GSK has over 100,000 employees worldwide, with close to 15,000 involved in research and development of high-quality medicines that contribute to good health of people all around the world.

 

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