Clinical Research Associate (CRA), Clinical Trials Unit
To assist the Clinical Trials Manager (CTM) in managing the clinical trial portfolios and operations in line with CRMY’s strategy for the Clinical/Translational Research Programmes (the “Programme”).
Responsibilities:
Clinical Trial Operations:
Ensure all delegated activities/tasks are completed and meet the objectives within the specified timeframe and resources.
Work under the supervision of the CTM to:
- Develop clinical trial documentation and toolkits for CRMY-sponsored Trials and Investigator Initiated Trials.
- Plan and manage clinical trials, whether conceived internally or externally.
- Support the CTM in conducting study feasibility assessments for new clinical trials.
Study Monitoring:
- Coordinate with clinical trial teams to organize periodic study monitoring visits (on-site or remote) to ensure compliance with study protocols, GCP, ICH guidelines, ethics, and regulatory requirements.
- Advise trial teams on GCP compliance and propose resolutions for findings/issues during monitoring visits.
- Deliver monitoring reports after each visit.
Data Management:
- Assist in designing eCRFs and testing EDC systems prior to migration to production.
- Help draft CRF Completion Guidelines and Data Monitoring Guides for new trials.
Sample Management:
- Coordinate sample management for IITs, ensuring sufficient supply of study materials and updating sites on protocol changes related to sample collection/processing.
- Coordinate shipment of biospecimens from sites to CRMY labs.
- Ensure biospecimens are stored or archived as per protocol.
Escalate critical issues related to Study and Site Management to the CTM.
Compliance and Quality Management:
- Collaborate with the CTM and research teams to develop and refine SOPs for clinical trial operations.
- Provide consultation on SOP compliance.
- Maintain GCP certificates for involved staff and inform staff about GCP workshops in Malaysia.
Other Responsibilities:
- Represent the team and Cancer Research Malaysia when appropriate.
- Undertake other administrative tasks as required.
Requirements:
- Degree in Life Sciences or related fields, with at least 1 year of clinical research or monitoring experience.
- Good knowledge of GCP, ICH guidelines, and IRB/EC requirements.
- Experience with SOPs and EDC systems like REDCap.
- Ability to connect various elements for proper study conduct.
- Meticulous, organized, independent, and deadline-oriented.
- Excellent communication and interpersonal skills.