We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level. You will become one of our first team members in Malaysia and contribute to the development of PSI Operations.You will:Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report all types of onsite monitoring visits.Be involved in study set-up, including site contract and budget negotiations.Be responsible for site communication and management.Ensure consistency of all study processes and identify country differences.Oversee maintenance of study-specific and corporate tracking systems.Contribute to the development and update of project planning documents, essential documents, and project instructions.Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.  Development of local language materials including local language Informed Consents and translations.Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.
