Clinical Research Site Assistant - Surrey
Lucy Stendall is recruiting for a freelance Clinical Research Site Assistant to join an innovative biopharmaceutical company, in Surrey on a 12 month contract initially. The main purpose of the role will be to: - Supporting the assigned Clinical Research Associates and investigator sites. Support will include operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices and company standards. - Provide technical and logistical support to the assigned Clinical Research Associate. - Assist with study site activation activities and coordinate operational activities to ensure timely site activation - Register investigator sites in the company's registries as required - Supports and/ or coordinates central Investigator Review Board (IRB) submissions when needed - Work with investigator sites to complete critical information for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status - May facilitate coordination of Clinical Research Associate and study team responses to the IRB - Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines - Maintain administrative and Study files - Act as a point contact for the Clinical Research Associate, Regional Clinical Site Lead or study team for designated project site communications, correspondence and associated documentation - Maintain ongoing contact and communication with the Clinical Research Associate, Regional Clinical Site Lead and study team as needed - Facilitate the submission of all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File documentation, monitoring visit reports, site visit follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics - Assist the Clinical Research Associate with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. In order to be considered for this role, you will be required to have the following qualifications, skills and experience: - School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor's degree in life sciences preferred - Previous experience in clinical site management - Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations - Must be fluent in English - Bilingualism is a key asset 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 CL39700 in all correspondence.