Senior/Clinical Research Associate
Core
Oversee and manage clinical trial site activities to ensure compliance with protocols, GCP, and regulatory requirements while ensuring patient safety and data integrity.
Role type
Senior Clinical Research Associate (Monitoring)
Builds
Clinical trials for oncology and rare disease therapies
Domain
Healthcare / Clinical Research / Oncology / Rare Diseases
Deliverable
client delivery
Required skills
Clinical monitoring, GCP/ICH-GCP knowledge, Site visit management, Data integrity review, Protocol deviation management, Investigational product accountability, Regulatory documentation, Clinical trial management systems proficiency
Preferred skills
Oncology and Phase I study experience, Extensive travel capability, Independent work in remote-enabled environments
Technologies
Microsoft Office (Word, Excel, PowerPoint, Outlook), Clinical trial management systems
Responsibilities
Conduct site visits (initiation, monitoring, qualification, close-out), Review investigator site files and align with Trial Master File, Track study progress and prepare monitoring reports, Identify and escalate protocol deviations and safety concerns, Support site start-up activities including ethics/IRB submissions, Review clinical data and resolve queries, Collaborate with investigators to resolve issues and ensure study delivery
Seniority
Senior, hands-on IC