Clinical Research Associate (CRA), Clinical Trials Unit

Scope / Purpose of Job:

To assist the Clinical Trials Manager (CTM) in management of the clinical trial portfolios and operations in line with the CRMY’s strategy for the Clinical/Translational Research Programmes (the “Programme”).

Responsibilities:

Clinical Trial Operations:

Ensure all activities/tasks delegated are completed and meeting the defined objectives within the specified timeframe and resources

Working under the supervision of the CTM to:

• • Develop clinical trials documentation and toolkits for CRMY sponsored Trials and Investigator Initiated Trials
  • Plan and manage clinical trials conceived internally or externally
  • Support the CTM in conducting study feasibility for new clinical trials

Study Monitoring:

• Coordinate with the respective clinical trial teams to organize periodical study monitoring visit (on-site or remotely) in ensuring trials are conducted in compliance to study protocol, GCP, ICH guidelines, ethics and regulatory requirements
• Advise clinical trial teams on matters pertaining to GCP compliance and propose resolutions to findings/issues identified during study monitoring visit
• Deliver monitoring report after each study monitoring visit

Data Management:

• • Assist CTM in designing the eCRF and perform test on the EDC prior migration to production mode
  • Assist CTM in drafting the CRF Completion Guideline and Data Monitoring Guide for new trials

Sample Management:

• • Coordinate sample management for IITs including ensuring the sufficient supply of study materials to be provided to Site and updating Site on changes on the protocol relating to sample collection/processing
  • Coordinate the shipment of biospecimen from Sites to CRMY lab
  • Ensure all biospecimen are stored or archived as specified in study protocol

Escalate critical issues pertaining to Study and Site Management to CTM 

Compliance and Quality Management:

• Work together with CTM and research teams to develop and refine Standard Operational Procedure (SOP) for clinical trial operations
• Provide consultation to study teams on the compliance to SOPs
• File and maintain GCP certificates of CRMY employee who are involved in Clinical Trial activities and provide information to CRMY staff on the latest GCP workshops in Malaysia

Other responsibilities include:

• To represent the team and Cancer Research Malaysia when appropriate
• To undertake other administrative tasks as required

Requirement:

1. Educated to degree level (Life Science or related fields), with minimal 1-year clinical research or clinical monitoring experience
2. Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and local IRB/EC requirements

1. 1. Experience with study management SOPs
   2. Experience with EDC system such as REDCap and basic knowledge on data management
   3. Ability to establish links between various elements necessary to the proper conduct of the clinical study
   4. Meticulous, detailed, well-organized and able to work independently to meet datelines
   5. Excellent communication and interpersonal skills
   6. Resourceful and able to multitask
   7. Certified GCP
   8. Adopts a pro-active attitude to work

1. Passion for CRMY's mission