Senior Clinical Research Associate

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.

We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.

Job Description

As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets. You will have the opportunity to work on clinical studies in various therapeutic areas and indications while maintaining the highest quality standards in the industry. This function operates at site and country level and can be assigned to projects as monitor or lead monitor.

Join the PSI team and help drive innovation and excellence in advancing healthcare solutions.

You will:

• Prepare, conduct and reports site selection, initiation, routine monitoring and close-out visits
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Act as a communication point between project teams and the site
• Leads project team calls on a country level
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions
• Prepare and participate in site audits and inspections

Qualifications

We have an office in both Tokyo and Osaka with hybrid work arrangement.

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• At least 3 years’ site monitoring experience at a CRA II or equivalent qualification level in Japan
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in feasibility assessment and study set-up process is preferable
• Therapeutic area experience in Oncology /Hematology /Gastroenterology (IBD) /Infectious Diseases /Neurology/Renal is a plus
• Full working proficiency in Japanese and Intermediate English
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel up to 30% to 40%