Clinical Research Associate II

Were searching for a knowledgeable teamoriented CRA II to manage the clinical aspects of fullservice global projects in Japan. As a CRA II at PSI you will work on the frontline of communication with project stakeholders ensuring timelines targets and standards of clinical research projects in a variety of therapeutic indications.  You will build and maintain relationships with clinical sites and investigators.  You will focus on subjects rights safety and wellbeing and quality of data compliance.

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup
• Perform CRF review source document verification and query resolution
• Facilitate site budgets and contract negotiations
• Monitor trial progress on the country level
• Be responsible for site communication and management
• Be a point of contact for inhouse support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Qualifications :

Office is based in Japan Tokyo (Hybrid/Remote work arrangement available) 

Applicants outside of Tokyo are welcome to apply! 

• College/University degree in Life Sciences Pharmacy RN or an equivalent combination of education training & experience
• Min. 2 years of independent onsite monitoring experience in Japan
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in feasibility assessment and study setup process is preferable
• Experience in Multiple Sclerosis Inflammatory Bowel Disease Oncology Infectious Diseases is a plus
• Full working proficiency in English and Japanese
• 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 problemsolving skills
• Ability to travel up to 30% to 40%

Additional Information :

How are we different

PSI is privately owned by the very people who founded the company more than 25 years ago and theyre still working here today. As a result we have grown organically around the globe and have kept our company fully independent giving us significant advantages and freedoms.  

Being a Part of the Team

As a part of the PSI team you will have a fair degree of ownership and autonomy to make nuanced countryand departmentspecific adjustments while nurturing the global PSI culture that unites us across six continents.

You will receive continuous support from your global peers and join a fastpaced innovative and resultsoriented working environment with lean communication lines. We pride ourselves on being approachable receptive to new ideas and open to feedback.

Growth Opportunities

PSI is proud to invest in our people from entrylevel team members to senior leaders helping you identify and hone your unique strengths at every step of your career. From onthejob learning experiences to formal development programs our professionals have a variety of opportunities to continue to grow throughout their career.

PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.

Remote Work :

No

Employment Type :

Fulltime