Apply: (Snr) CRA, Malaysia

Our client, one of the leading contract research organizations, is looking for (Snr) CRAs to join their team in Malaysia. This person will be exposed to varied therapeutic areas and play an integral role in local and regional clinical projects.


JOB RESPONSIBILITIES

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
• Support the development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Act as a mentor for clinical staff including conducting co-monitoring and training visits
• May provide assistance with design of study tools, documents and processes
• Convey features and opportunities of study to site
• Collaborate and liaise with study team members for project execution support as appropriate

REQUIREMENTS

• Bachelor's Degree in Healthcare or other scientific discipline
• 3 years of clinical monitoring experience
• Strong knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Strong written and verbal communication skills including good command of English language
• Strong organizational and problem-solving skills
• Effective time management skills
• Ability to manage competing priorities
• Good mentoring and training skills
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

Reg No. R1109555
EBC Connect Pte Ltd
Licence no. 17C8975