Senior Clinical Research Associate

Manila, Metro Manila, Philippines
PHP 100,000
Health
Manufacturing

Executive recruitment company Monroe Consulting Group Philippines is recruiting on behalf of a multinational company that provides consulting and clinical trial support services for companies without entities in SEA.  Our respected client is seeking a Senior Clinical Research Associate that will handle the Philippine market. The candidate will work remote.

Key job responsibilities include:

Clinical Development Operations

  • Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
  • Primary point of contact of trial sites with regards to the conduct of the study/ project
  • Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
  • Ensure that the sites are adequately trained on the protocol and other study specific requirements
  • Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
  • Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF). 
  • Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
  • Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
  • Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
  • Track site budget and payments
  • May be involved in preparation of status reports for clients
  • Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
  • Act as mentor/coach to more junior staff as necessary
  • Travel as necessary according to project needs
  • Perform other duties as assigned by line manager

Regulatory

  • Ensure study start up processes are done according to applicable SOPs and regulatory requirements
  • Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB)
  • Ensure that product labels are compliant with applicable regulatory requirements
  • Collect and submit necessary documents for study drug importation, return and/ or destruction
  • Ensure that all documents necessary for site activation are collected

Job Requirements:

  • Bachelor’s degree in life science, chemistry, or health is preferred.
  • ICH-GCP training is required
  • Relevant experience on conduct of clinical trials and on-site monitoring
  • Excellent communication, both written and verbal, and interpersonal skills
  • Fluency in English is required
  • Proficiency in MS Office programs
window size: toggle grid