Description
The CRA should ensure adherence to International Conference On Harmonization- Good Clinical Practice (ICH-GCP), Sponsor & Phoenix CR SOPs, Study Protocols and all applicable regulatory requirements.
Location: UAE
Principal Duties and Responsibilities:
• Schedules, plans, and performs site visits according to the monitoring plan and SOPs to ensure appropriate site visit activities are completed at each onsite or remote visit with the close supervision of the Clinical Operations Manager
• Under Clinical Operations Manager supervision, supports on assigned trials by tracking Submission, approvals, recruitment and data cleaning activities.
• Under Clinical Operations Manager supervision, communicates with sites on assigned trials to manage trial milestones and issues.
• Assists with site feasibility, qualification and selection process under close supervision of the Clinical Operations Manager
• Under Clinical Operations Manager supervision, supports site staff in startup activities and ensuring site is ready for activation before SIV.
• Under Clinical Operations Manager supervision, train site staff on all clinical trial procedures and documents
• Under Clinical Operations Manager supervision, assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by Sponsor and works with the site to resolve queries. Prepares monitoring reports and letters in a timely manner using approved company /Sponsor forms and reports
• Ensures that necessary study supplies are available at sites as necessary, coordinating with appropriate vendors as needed (i.e., Case Report Forms, Study Manuals, lab kits, drug supplies, lab supplies, etc.)
• Applies judgment and knowledge to independently resolve sites issues, questions and concerns under Clinical Operations Manager’s guidance.
• Responsible for follow-up on patient recruitment rate as per the Site Recruitment Action Plan (SRAP)
• Under Clinical Operations Manager supervision, assists with final data review and query resolution through database lock
• Reviews subject safety data and AEs/SAEs and ensures appropriate follow-up and reporting within protocol/regulatory required timelines
• Maintains Investigator Site File (ISF) up to date as well as all other clinical trial documents
• Attends Investigator Meetings for assigned studies
Requirements:
• Holds a Bachelor Degree, or equivalent, in a scientific/medical discipline
• Currently based in UAE
• At least 1 year of experience as a CRA in UAE
• Fluent in Arabic as a Mother tongue besides English. Other languages are preferred
• Enthusiastic, motivated and able to work independently and communicate with a variety of healthcare professionals at monitoring sites
• Deals with confidential information and/or issues using discretion and judgment
• Basic good knowledge and ability to apply ICH/GCP and any other applicable international guidelines, applicable local regulatory guidelines and Standard Operating Procedures
• Valid Driver’s License where applicable
Interested candidates can send their CVs on: jnassrani@phoenix-cr.com
Only candidates with the above requirements will be considered
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