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.
REQUIREMENTS
- 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:
Subject: Clinical Research Associate
EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registraion No.: 99C4599
