CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.
We are currently seeking Clinical Research Associate (CRA) Site Managers currently based in Japan.
The candidate will have the following responsibilities and qualifications:
* Drafts materials including informed consents, case report forms (CRFs), CRF completion guidelines, and technical instructions.
* Carries out clinical site qualification, contract negotiation, IRB/ethical committee submissions, protocol initiation, site monitoring, and site close-out
* Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
* Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
* Conducts clinical site and data monitoring and completes monitoring visit reports
* Supports study supply, biospecimen delivery, and biospecimen testing logistics
* Evaluates clinical data and coordinates data query resolutions
* Supports internal departmental quality compliance
* Prepares progress reports and performance metrics
Clinical Research Competencies:
* >2 years clinical site management and monitoring experience
* Understands and can apply knowledge of clinical trial designs to trial execution
* Advanced knowledge and experience with GCP/ICH and local regulations
* Experience in web-based data collection applications, knowledge of key areas for compliance
* Strong communication skills as single point of contact for investigator
* Excellent organizational skills with high attention to detail is required
* Strong computer skills (spreadsheets, word processing, etc.) is required
* Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
* Strong skills in building and maintaining relationships with investigative sites
* Strong presentation skills to internal professionals and external collaborators