Senior Clinical Research Associate

map_markerStockley Park CoinNegotiable

Vacancy summary

Vacancy summary

Reference: 00392

Job Type: Permanent

Date Posted: 10 August 2016

Senior CRA- Phase I-II Oncology—12month Contract, possible extension- West London This is a fantastic opportunity for a Senior CRA to join a Global Biopharmaceutical company specialising in Early Phase Oncology trials. This would be a 12month contract role with possible extension. As a Senior Clinical Research Associate you will have full 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 • Experience working in Phase I-II trials • Regulations- ICH, GCP, CRF, EU CT • Strong management experience • Oncology 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

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