Clinical Research Associate
Abu Dhabi, United Arab Emirates
Job Description
Overview:
Insights Research Organization & Solutions (IROS) is the first UAE-based Contract Research Organization (CRO) specializing in healthcare research. From clinical trials across all therapeutic areas to integration of real-world data, we provide the highest international ethical and scientific standards in clinical trial management, as well as key insights that lead to innovative, life-changing treatments. Responsibilities:
- 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
- BSc degree in life science
- 4 year of clinical research, and trial conduction
- Responsible for at least 3 Interventional Clinical trials covering all trial cycle
- Excellent decision making and organizational skills
- Good time management skills
- Excellent team working skills
- Proficient in MS Office (Excel, Access, Word etc.)
- Excellent communication and collaboration skills
- Good research and organizational abilities
- Capability and Skills
- Good knowledge of GCP with certification
- Good Documentation skills
- Good management and leadership skills
- Strong communication 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.
- Strong interpersonal skills, great team player
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Job Detail
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Job IdJD1502513
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAbu Dhabi, United Arab Emirates
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EducationNot mentioned