CRA II - Pharma Company

I am currently looking for a  CRA II with 12-18 months' UK experience on behalf of a global CRO. You will be responsible for monitoring all clinical trials within the oncology therapy area. This is a home based position though can also be based from the company's Berkshire headquarters.

Responsibilities:

• Assure compliance with CFR, ICH and GCP guidelines and SOPs.

• Maintain current regulatory documentation according to Essential Regulatory Document Guidelines and TMF Plan.

• Assume responsibility for site management and site staff performance

• Participate in all types of site visits.

• Ensure compliance with all protocol requirements.

• Ensure effective patient identification and recruitment plan is in place.

• Ensure timely reporting of AEs/ SAEs and Protocol Violations.

• Perform observation visits with less experienced CRAs.

• Perform source document verification (SDV) according to contractual requirements.

• Ensures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).

Requirements:

• Degree educated the science/health care field or nursing degree or equivalent

• Experience in monitoring clinical trials preferably within a CRO

• Experience within the oncology therapy area

• Must have valid, current driver’s license