Job Description
:
We are seeking a highly motivated team member to support clinical investigations as a Clinical Research Associate.
Your main responsibilities:
1. Support timely delivery of clinical investigation in collaboration with study-assigned Clinical Research Manager (CRM)
2. Adhere to required quality standards and laws/regulations
3. Independently perform monitoring visits, including site qualification, study site initiation, routine monitoring, and study site closure visits
4. Ensure source data verification (SDV) and timely query resolution
5. Assist in investigation start-up activities, eg. Site selection visits and review of regulatory documents
6. Establish and maintain regular contact with investigators and, the ethics committee as needed
7. Prepare and maintain the investigator file, center file, and study master file
8. Communicate project-specific information to/from trial sites, document communication with investigations site/teams, and escalate issues to CRM in a timely manner
9. Present at and participate in investigator meetings, other study trainings, and meetings as assigned
10. Support statistical evaluation of study results within the clinical operations
11. Support timely delivery of clinical documentation needed in product development projects, e.g. clinical investigation reports
12. Screening and identifying business and product-relevant scientific literature as assigned