Title: Clinical Research Associate
- More than 1 year monitoring experience
- 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.
- Set-up of a study with regard to submission and approval process and preparation of the documentation as per all applicable local requirements; keep EC and Regulatory authorities informed about study progress and changes.
- Collect 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.
- 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
- Act as a guide for juniors if needed.
If interested, please send your CV to firstname.lastname@example.org mentioning the Job Title in the subject