Clinical Research Associate II - Surrey
Lucy Stendall is recruiting for a freelance Clinical Research Associate II to join an innovative biopharmaceutical company, working field based, reporting to their site in Surrey. The main purpose of the role will be to - Be responsible for the identification, evaluation, selection, initiation, monitoring and close out of assigned clinical trial investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices and company standards. - The Clinical Research Associate II role is accountable for clinical trial monitoring and managing investigator site relationships to ensure effective delivery of clinical trials (e.g. site activation, enrolment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site health), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. - The Clinical Research Associate II is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with study team members as required in activities associated with the set-up, running and close out of a clinical trial. - Provide input into and/or develop study related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, data completions guidelines, patient diaries, recruitment plans, and patient informed consents - Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals, etc.) and take appropriate targeted action - Identify, evaluate and select investigator sites as needed - Serve as the primary point of contact for assigned investigator sites - Manage external vendors as needed - Perform site qualification/Pre-Trial Assessment Visits and ensure selected sites have appropriate capabilities and access to patient populations to meet protocol and timeline requirements - In collaboration with Clinical Research Site Assistant and Outsourcing Lead, oversee site payments per contracts and work with the appropriate groups to resolve issues - Attend investigator meeting when required and develop/conduct investigator meeting presentations and/or trainings as required - Support study team as needed with Regulatory, Central, and Local Ethics Submissions and responses - Train and coach Clinical Research Associates I and/or Clinical Research Site Assistants as assigned In order to be considered for this role, you will be required to have the following qualifications, skills and experience: - Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent - Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations - Extensive monitoring experience - Experience in the development of study-related documents is beneficial - Required therapeutic experience in oncology - Global clinical trial experience - Must be fluent in English Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained. CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL39612 in all correspondence.