Experienced Clinical Research Associate

*We have mutiple Onboarding Batches to accomodate to your graduation date/current situation.

Experienced Clinical Research Associate (CRA) - join our growing team in Osaka, Japan!

Medpace is growing quickly and we are seeking experienced Clinical Research Associates to join our team. We are an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work.

Through our fast PACE^® (Professional Achieving CRA Excellence) Training Program, you will receive customized, expedited training, and efficient onboarding to familiarize you with Medpace systems.  

WE OFFER THE FOLLOWING:

• Customized training program based on your experience and therapeutic background and interest;
• Annual company bonus;
• Annual merit salary increases;
• Defined Contribution Plan;
• Group term life insurance with insurance premium coverage; Insurance association benefits available;
• The opportunity to work from home;
• Flexible work hours across days within a month;
• Laptop, mobile phone with hotspot for internet access anywhere and home office furniture allowance for home-based CRAs;
• Opportunity for leadership positions/career advancement – Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, etc.;
• User friendly Clinical Trial Management System (CTMS) with electronic submission and approval of monitoring visit reports;
• Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
• In-house administrative support for all levels of CRAs;
• Opportunities to work with international team of CRAs; and
• Many additional perks unmatched by other CROs!
• Since most studies are global trials, opportunities to collaborate with the global team/vendor and contribute to the success of the clinical trial.
• Opportunities to experience complex study involvement, including oncology, rare disease, phase1 First-in-Human studies. So, CRAs will gain high-level monitoring experience and contribute to society.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements (J-GCP);
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Clinical Research Associate experience (minimum 1 year);
• Native level Japanese (JLPT N1) is standard, a minimum English TOEIC score of 500 or equivalent
• Must have a minimum of a bachelor’s degree in a health or science related field;
• Ability to travel 30-50%/month to locations nationwide is required;
• Proficient knowledge of Microsoft^® Office;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
  • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• • Office based environment with on-site mentors
  • Defined career paths with clear advancement opportunities
  • Industry renowned onboarding and training programs designed to accelerate professional development
  • Ongoing training and continuous learning opportunities throughout your career
  • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• • Competitive compensation programs that recognize and reward performance
  • Comprehensive health, wellness, retirement, and PTO benefits
  • Office based culture with occasional WFH that provides flexibility for eligible positions after training
  • Company-sponsored social events 

Please note benefits may vary based on country. 

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.