Senior/Principal CRA

Senior Clinical Research Associate | 12month Contract 

This is a fantastic opportunity for a Senior CRA to join a Global pharmaceutical company specialising in Early Phase Oncology and Haematology trials. This will be a 12-month initial contract. As a Senior Clinical Research Associate you will have monitoring responsibilities across numerous sites, excellent knowledge of study regulations and strong team management. 

Key Responsibilities
• Investigative site monitoring, SMPs, pre-study visits, monitoring visits, Trial Master Files
• Ensure site compliance with GCP/ICH guidelines
• Verify and submission of CRFs
• Study Safety, including; monitoring consent procedures, safety reviews, ensuring correct dispensing
• Attend investigator meetings
• Ethics submissions, reviewing translations for ICD and study documents for local authorities. 
• Liaise with Regulatory Affairs dept for submissions and changes

Key Skills
• Strong experience as a CRA within a Pharmaceutical environment
• Early development and study start-up experience
• Regulations- ICH, GCP, CRF, EU CT
• Strong management experience 
• Oncology/Haematology experience is preferable

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.

Drug safety specialist, drug safety, pharmacovigilance, Risk Management Plans, clinical trials, FDA, EMA, ICH guidelines