☑English language required
☑Japanese language required
Clinical Research Associate
This position provides oversight of clinical research sites compliance with Good Clinical Practices, ISO-14155 and applicable laws and regulations, standard operating procedures, Company's Code of Conduct, and study protocols.
- Serves as the primary point of contact for assigned clinical research sites.
- Performs site development and training (supporting and coaching site personnel), site set-up, site monitoring (evaluation of site performance and identification of issues), and site close-out activities for assigned clinical research sites with designated program SOPs, Client expectations, clinical study protocols and GCPs.
- Problem solves (including CAPA development where necessary) identified issues with appropriate escalation to Clinical Study Manager and/or Clinical Director.
- Assures protection of the rights, safety, and well-being of subjects, study integrity and data quality.
- Leads/supports temporary CRO-CRA(s), if applicable.
- Performs activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, device accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution.
- Facilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site file.
- Manages IRB/EC/CRB submissions including; workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB/EC/CRB in conjunction with study team/site staff as applicable.
- Maintains awareness of site dynamics and able to motivate, persuade and educate site staff.
- Complies with the Clinical Monitoring Plan and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the studies within the program.
- Completes monitoring reports in compliance with requirements in the Clinical Monitoring Plan.
- Exhibits ability to proactively identify and interpret problems, recommend creative solutions, and influence appropriate changes.
- May support more than one clinical study.
- Complies with all objectives and metrics related to study and program execution.
- Attend meetings as requested (i.e. investigator, study, program) to gain and/or share program/study/site knowledge.
- Follow, maintain and improve current SOPs.
- Bachelor of Science (Life science or related field) or equivalent (Master of Science are desirable).
- Minimum 3 years' experience in clinical study implementation at medical device/pharmaceutical/biotechnology industry or at CRO for CRA. Over 5 years' experience for Sr. CRA. Experience in lead monitor is preferred.
- Practical and theoretical knowledge of applicable laws and regulations (GCP, ISO 14155, etc).
- Clinical research/development experience in medical device industry is strongly preferred. Orthopedic and/or wound management experience at prior companies is nice to have.
- Good communication skills with investigators, research coordinators, other site staff and S+N employees.
- Microsoft proficiency
- Ability to read and write in English. Business level English skills preferred.
- Ability to travel as required to meet project objectives.
- Medidata RAVE experience preferred.
- English Language level: Ability to read and write in English. Business level English skills preferred
- Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
- Work permission in Japan required
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider