Clinical Trials Coordinator 339

ProductLife Group is looking for a Clinical Trials Coordinator to join our dynamic teams ASAP.

About us

Group 10
Responsibilities

The tasks will include, but are not limited to:
– Assemble and track availability of essential documents required for study conduct
– Update, maintain and monitor CTMS to allow accurate project management, regulatory reporting
– Updating of clinical and study planning spreadsheets/trackers
– QC essential documents, clinical milestones and other study documentation for completeness, consistency and accuracy.
– Follow-up/check return or destruction of study drug
– Updating of clinical and study planning databases
– Review study budgets/clinical trial agreements for consistency with study protocol
-ABC (anti-bribery + corruption checks) on all HCP (fact finding, workflows, tracking, renewals) + troubleshooting with compliance, technical services etc.
-Clinical trial payments and payment tracking
-Financial disclosure (check need, track, process letters and documentation)
-Denied parties screening (DPS)
– Compliance checks : disclosure agreements: Generate and track
– Trial master file reconciliation of clinical grants/compliance documents
– Maintenance of trackers : GMS (grants management system): enter and track payments, run reports
– Execute payments in COMET (SAP), purchase orders as needed

Group 11
Education

– Bachelor degree (e.g. medical assistant, or paramedical education) or Master degree in health science

Group 12
Experience

  • Similar experience of 1-3 years

Group 13
Skills

  • Advanced computer skills: e.g. professional using of MS Office programs for daily business : Excel. Candidate must be able to build quick basic understanding of SAP COMET, Grants Management System en eTMF (VAULT)
  • Advanced communication skills
  • Understanding and knowledge of study protocols and study working documents, lab manuals, etc
  • Good understanding of the clinical research processes
  • Understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations
  • Ability to work well within a team
  • Process orientated with good attention to detail
  • Effective oral and written communication skills

Group 10

Clinical Trials Coordinator 339