Agensi Pekerjaan A S K Resources Sdn Bhd is looking for new potential candidates to fill in for Clinical Research Associate (Contact basic) position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- In collaboration with the MA / CRA Manager / Lead CRA, participate in the feasibility meetings, design & implement feasibility questionnaires and assess suitability of trial & sites upon receipt of responses
- Assist CRA Manager / Lead CRA in performing site selection visits and writing of associated reports
- Liaise with clinical teams to obtain all documents associated with country-specific FPP.
- Prepare/review the localized Patient Information and Consent Forms from Global templates ensuring compliance with ICH GCP and local regulatory requirements; obtaining translations as required
- Assist sites with completion of IRB submission dossier and ensure collection of necessary site level documents at trial start-up and throughout conduct of the study.
- Prepare required regulatory submissions at trial start up, and throughout conduct of the study when required
- Coordinate site start up activities including contract negotiations, import licenses for IP / lab kits and vendor set-up.
- Prepare study budget and TCFs in consultation with Lead CRA and CRA Manager
- Oversee the preparation of essential documents folders for all sites participating in the study
- Prepare/review the RIS checklist and ensure all elements completed in accordance with QCSP and local SOPs
- Participate in trial site training activities including site initiation visits, as assigned. Support Lead CRA at site initiation meetings.
- Track submissions and status of start-up activities for all trials.
- Responsible for the Investigator Notification distribution process and all associated activities i.e. maintenance of IN contact list, tracking
- Support the CRAs with other study-related activities, such as interim TMF reviews, drug destruction, close-out visits, archiving, CQA audit preparation and other activities, as required. Co-monitoring with CRAs may be required during low activity periods as well
- Assist with monitoring of studies, as required.
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
- Demonstrates ability to coordinate, organize and communicate
- Basic understanding of clinical development process including GCP and ICH fundamentals
- Proven ability to work on teams and deliver on commitments
- Level of proficiency inadequacy with CRA I competency profile.
How To Apply
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