Principal CRA

Principal CRA - Cambridgeshire - 6 month contract

This is an exciting opportunity for an office-based Principal CRA on a 6 month contract with a global pharmaceutical company based in Cambridgeshire. This individual will be working on a European study that is currently at analysis stage, managing CROs/vendors, coordinating all aspects of clinical study, and interact with cross-functional teams internally and externally. This is a rapidly growing company and an excellent time to join the team. This company is very people orientated and has an extremely friendly working environment.

Essential duties and job functions will be:
*Able to manage day to day logistics of global PII-IV outsourced studies managed by a US-based or EU-based Clinical Program Manager.
*Coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
*Supports Study Timelines and tracks Site progress.
*Contributes to management of study budget.
*Manages CROs/vendors.
*Will serve as the secondary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
*May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
*Conducts Monitoring/co-monitoring as required.
*Manages appropriate TMF filing and archiving.
*Assists in determining the activities to support a project's priorities within functional area.
*Coordinates all aspects of a clinical study including internal communications of meetings and agendas. Interacts with cross-functional teams internally and externally to ensure trial progress.
*Will incorporate study logistics and planning to accomplish study objectives.
*Facilitates audit preparation and contributes toward resolution of CAPAs.
*Coordinates and reviews data listings for preparation of interim/final clinical study reports.
*Under supervision, may design scientific communications within the company.
*Assists Clinical Operations International Therapeutic Area Leads in their duties including conducting local feasibility activities.
*Contributes to Clinical Operations International team activities & initiatives when appropriate.
*May serve as a resource for others within the company for clinical trials management expertise.
*Under general supervision, is able to examine functional issues from an organizational perspective.
*Works with Clinical Program Managers to manage the EMEA component of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes. Ensures Clinical Trial Management System is maintained for all studies run locally.
*May contribute to development of abstracts, presentations, and manuscripts.

Candidates must have:
*4+ years experience
*A BSc or nursing qualification in a relevant scientific discipline.
*Multinational (preferably EU) clinical trials experience including study management/coordination.
*Monitoring experience.
*Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
*Must be able to generally understand, interpret, and explain protocol requirements to others.
*Must be able to prioritize multiple tasks and participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
*Must have a general, functional expertise to support SOP development and implementation.
*Ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
*Excellent teamwork, communication, decision-making and organizational skills are required.
*International travel may be required (up to approximately 20%)

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). 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.