Senior Clinical Research Associate

We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Taiwan. 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.
Location: Taipei, Taiwan
Training, mentoring and supervising study level responsibilities for Junior CRAs
Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
Delivering training of investigators, site staff and project teams
Work with complex studies
Perform CRF review, source document verification and query resolution
Be responsible for site communication and management
Be involved in site identification process
Contact for clinical investigators, vendors and support services in regard to study progress
Participate in feasibility research
Preparation and delivering of presentations at Investigator’s Meetings
Preparation for and attendance at company’s audits; resolution of audit findings
Support to Regulatory Affairs in procurement of site regulatory documents
Maintenance of study-specific automated tracking systems
College/University degree in Life Sciences or an equivalent combination of education, training & experience
Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise
Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.
Proficiency in feasibility assessment and study set-up processes is highly desirable.
Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment.
Superior communication, collaboration, and problem-solving skills are essential.
Willingness and ability to travel.
If you like to train and support others on their clinical research steps, and are also looking forward to future Lead Monitor roles, this position may just be the right one for you.

Employment type
Full-time

Work arrangement
Hybrid