Clinical Research Associate
1 month ago
Responsibilities:
- 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.
- min. Bachelor’s Degree in Science or a related field preferred.
- Posess min. 2 years’ prior CRA experience is preferred, however, other relevant experience and skills may be considered.
- Good understanding of GCPs (Good Clinical Practices).
- Excellent interpersonal and communication skills
Interested candidates please send your updated resume to:
kate.leau@recruitexpress.com.sg
Subject: Clinical Research Associate
EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registraion No.: 99C4599
Tell employers what skills you have
Clinical Research Associate
Drug Development
Clinical Research
Site Management
Data Management
Clinical Development
Data Quality
Clinical Trials
Protocol
Biotechnology
Compliance
IP
Communication Skills
Administrative Support
GCP
Regulatory Requirements
Audit
Clinical Monitoring
Trial Management
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