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Clinical Research Associate
2 weeks ago
Job Description
- Support the investigators in implementing clinical trials protocols:
- Liaise with the study site personal to implement the study per global and local requirements.
- Ensure compliance with all ethical, regulatory and contractual requirements.
- Training of study site personal (protocol, use of IP, SOPs, etc.).
- Ensuring data quality and integrity of clinical study data:
- Conducts site monitoring visits and follow-up to identify deviations & issues and to ensure that all clinical aspects of studies are being carried out in accordance with the protocol, regulations, guidelines and policies.
- Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance.
- Identifies deficiencies and discrepancies, and provides remedial training and/or implement corrective and preventive actions as required.
- Liaise with data management, reviews case report form queries, clarifies and/or obtains changes to data as appropriate.
- Create, update, track, and maintain study-specific trial management files. Ensure study documents are audit ready.
- Co-ordinate and track meetings with CROs, vendors, investigators and internal teams.
- Update and maintain clinical department management tools and systems, as required.
- Provide administrative support as required
Job Requirements
- Min. Bachelor's Degree in Science or a related field of study.
- Min. 2 years' CRA experience preferred, any other relevant experience and skills may be considered.
- Good understanding of GCPs (Good Clinical Practices).
- Advanced analytical thinking skills and numeracy grasp.
- Strong in using project management tools and Microsoft Office
Interested applicants, please email your updated CV to or WA for more information.
Recruiter's Ref Code: #HHM
EA Personnel No: R
EA Personnel Name: Reina Ng Hwee Min
Company Registration Number: Recruit Express Pte Ltd (99C4599)
Tell employers what skills you haveClinical Research Associate
Pharmaceutical Industry
Microsoft Office
Clinical Research
Clinical Research Administration
Data Management
Data Quality
Clinical Trials
Protocol
Pharmaceutical Sciences
IP
GCP
Regulatory Requirements
Audit
Clinical Monitoring
Trial Management
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