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Job Details:
Position Name : Clinical Research Associate (CRA)
Location: Abu Dhabi
Job ID : 12eb8686eddf0140
Description : 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
Sector
Healthcare / Pharmaceutical
Location
Abu Dhabi
Contract type
Permanent
Consultant name
Lara Haidous
Job reference
JN-112021-4512851
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