Clinical Research Associate

We are looking for an organized, self-motivated clinical research associate to oversee clinical trials. You develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. You will conduct regular site visits, generate and distribute materials, prepare final reports etc. You will play a leading role in generating and overseeing documentation and records.

Ideal candidates will be detail-oriented, have the ability to multitask, and be able to collaborate with various role players.

Responsibilities:

  • Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial
  • Training site staff on Investigational Product, protocol requirements, proper source documentation, and case report form completion
  • Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects
  • Ordering, tracking, and managing trial materials
  • Conducting regular site visits, coordinating project meetings, and writing visit reports
  • Implementing action plans for sites not meeting expectations
  • Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines

Requirements:

  • Bachelor’s degree in medical field or other relevant education
  • 2+ years of experience as a clinical research associate
  • Knowledge of GCP/CE/FDA regulations and their practical implementation
  • Strong verbal and written communication skills
  • Excellent English (verbal and written)
  • Proficient with Microsoft Office Word, Excel, and PowerPoint
  • Ability to manage and prioritize workload effectively