Aerotek Cambridge, Cambridge, UK
JOB DUTIES & RESPONSIBILITIES Maintain trial master file, study site records and files and ensure compliance with applicable SOPs Create, implement, and maintain systems to track study metrics and general information (ex. OPAL and IMPACT, etc.) Coordinate generation of study metric reports and action logs Review of essential study documents Process study-related documents and materials - to include collation, filing, routing coordination of third-party provider document shipments to MedImmune Initiate contract/budget requests and track ongoing status Schedule team meetings and prepare agendas and minutes Prepare and distribute study-related correspondence Organise and ship study supplies to clinical sites Participate in identification and selection of clinical study sites, including conducting searches of web-based databases Develop study specific procedures and tools Assist clinical operations team with study management Participate in vendor selection and ongoing vendor management Generate purchase orders, process vendor invoices and assist in tracking spend against approved budget Assist in the organisation of advisory boards and investigator meetings. Track approvals and completion of required documents. Assist in the clinical trial insurance process. Track approvals, revisions and renewals of certificates Perform other functions as necessary or as assigned QUALIFICATIONS & EXPERIENCE Bachelor's Degree preferred 2-3 year's clinical trial experience and at least 1 year experience in an office or laboratory environment Professional demeanour and ability to work as a team member Experience with Microsoft Office Suite (Word, Powerpoint, Excel) Ability to coordinate and prioritise multiple tasks Demonstrated verbal and written communication skills Demonstrated interpersonal and problem solving skills Proactive approach and the ability to act independently, or as part of a diverse team Understanding of ICH, GCP and relevant regulatory requirements Familiarity with drug names, diagnoses and medical/research terminology Ability to work as part of a global team Willingness to travel to attend periodic meetings will be required Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice. By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.