Senior Clinical Research Associate - Contract
Core
Senior Clinical Research Associate monitoring oncology and medical device clinical trials, specifically focusing on therapeutic medical devices and HIFU therapy.
Role type
Senior Clinical Research Associate (Contract/Freelance)
Builds
Clinical trial data and safety reports for pharmaceutical, biotechnology, and medical device sponsors
Domain
Oncology, Medical Devices, Clinical Research
Deliverable
client delivery
Required skills
On-site monitoring, Source Data Verification (SDV), Case Report Form (CRF) review, Site initiation and selection, Investigational product management, Safety reporting (AE/SAE/SUSAR), GCP/ICH compliance, CRF design, Study budget negotiation
Preferred skills
Gastrointestinal oncology experience, HIFU therapy experience, Nursing degree
Technologies
Microsoft Office (Word, Excel, Outlook)
Responsibilities
Conduct periodic monitoring visits and source data verification; Train site staff on study procedures; Manage investigational products and trial materials; Report safety issues and follow up on AEs/SAEs; Assist with site selection, initiation, and study start-up; Develop training materials; Support contract negotiation and CRF design.
Seniority
Senior, hands-on IC