Essential Functions and Other Job Information
1. Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collecting the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
2. Site selection and qualification evaluation under supervision of senior personnel.
3. Assist during a study set-up regarding a submission and approval process and preparation of the documentation as per all applicable local requirements.
4. Collecting all ECs requirements per allocated studies.
5. Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
6. 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.
7. Reviewing 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.
8. Reporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
9. Ensuring the study is conducted in accordance with international and national regulatory
requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc)
10. 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.
11. Providing any requested internal progress reports and completion of the relevant files
12. Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.
13. First line of communication for any study related issues arisen by sites for studies lead by him/ her.
14. Execute any activities in compliance with applicable SOPs, instructions, and principles.
15. Responsible for issues escalation following the proper escalation pathway.
Education and Experience
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities
Working Conditions and Environment
Note : This job ad is open for all levels of CRAs I,II,III