For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
ProPharma is seeking an experienced contract Clinical Study Coordinator to support a part-time position (.25 FTE) on an upcoming gastroenterology study based out of Japan, beginning in September. This is an exciting opportunity to contribute to high-quality global clinical research while collaborating with a dynamic, cross-functional team dedicated to improving patient outcomes.
Position Summary:
The Clinical Coordinator will serve as the primary point of contact for day-to-day communication with Japanese study sites and will support a variety of clinical and administrative functions throughout the study lifecycle. The ideal candidate will have strong organizational skills, cross-cultural sensitivity, and the ability to manage site communications and documentation efficiently in a remote setting.
Key Responsibilities:
Serve as the main point of contact for Japanese study site communications and coordination.
Track and manage document submissions and site activities.
Support subject pre-screening, screening, and recruitment efforts.
Manage subject re-consenting and medical record acquisition, under the direction of the Principal Investigator.
Conduct protocol-required activities and data entry.
Respond to system queries and monitor clinical databases.
Maintain consistent and timely communication with study sites in Japan.
Ensure study documentation complies with IRB, FDA, and GCP standards.
Assist with study closeout procedures and additional study-related tasks as needed.
Perform other duties as assigned.
Education Requirements:
Bachelor’s degree preferred OR a minimum of 2 years of relevant combined education, knowledge, and experience to perform the responsibilities effectively.
Experience Requirements:
Minimum of 2 years of experience as a Clinical Study Coordinator/Study Coordinator, Research Coordinator
Prior experience supporting studies in Japan is highly desirable.
Skills and Competencies:
Comfortable using technology and web-based platforms on Microsoft OS.
Study team experience strongly preferred.
Strong critical thinking and organizational skills.
Excellent verbal and written communication skills, with sensitivity to cultural and time zone differences.
Ability to work independently while collaborating effectively with cross-functional teams.
Must have access to a private, secure remote work environment.
Familiarity with ICH/GCP guidelines and applicable global regulations.
Proficient in following SOPs and standard business processes.
Professional, articulate, and proactive in communication.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
