Clinical research Associate (CRA)

Abu Dhabi Permanent
  • To work with a CRO of one of its kind in the UAE
  • To join a leading healthcare organization in the UAE with an inspiring vision

About Our Client

A newly launched clinical research organisation in the UAE that provides multiple services across health care. Their aim is to facilitate the highest standard of clinical trials globally that can service the unique populations of the region and benefit communities worldwide.

With their expertise in data research, project management, testing, and trials, enables pharmaceutical companies to develop new medicines and drugs in a cost-effective manner, which will allow them to enter new products to market more efficiently.

Job Description

  • Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs
  • Site selection and qualification evaluation under supervision of senior personnel
  • Assists during a study set-up regarding a submission and approval process and preparation of the documentation as per all applicable local requirements
  • Collects all ECs requirements per allocated studies
  • Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study
  • Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance. Strictly follows everything stipulated under ICH-GCP, point 5.18
  • Review and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM
  • Reporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences
  • Ensuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc)
  • Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sites
  • Providing any requested internal progress reports and completion of the relevant files
  • Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks
  • First line of communication for any study related issues arisen by sites for studies lead by him/ her
  • Execute any activities in compliance with applicable SOPs, instructions, and principles
  • Responsible for issues escalation following the proper escalation pathway
  • Provide internal training to the team on specific topic

The Successful Applicant

  • BSc degree in life science
  • Responsible for at least 3 Interventional Clinical trials covering all trial cycle
  • Excellent decision making and organizational skills, time management and team working skills
  • Proficient in MS Office (Excel, Access, Word etc.)
  • Good research and organizational abilities
  • Good knowledge of GCP with certification
  • Good Documentation skills
  • Good management and leadership skills
  • Great organizational, planning and multitasking skills
  • Demonstrated superior communication skills in cross-cultural environments
  • Ability to prioritize responsibilities and work effectively in a matrix environment with tight deadlines.

What's on Offer

Competitive salary and family inclusive benefits!

Contact
Lara Haidous
Quote job ref
JN-112021-4512851

Job summary

Sector
Healthcare & Life Sciences
Subsector
Research & Development
Industry
Healthcare / Pharmaceutical
Location
Abu Dhabi
Contract type
Permanent
Consultant name
Lara Haidous
Job reference
JN-112021-4512851