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Senior Clinical Research Associate (Senior CRA)

Senior Clinical Research Associate (Senior CRA)

Cambridge, UK

MedImmune, the global biologics unit of AstraZeneca, is committed to developing better medicines that help people live healthier, longer and more satisfying lives. The company is focused on the areas of infection, respiratory and inflammatory disease, oncology and neuroscience, with two marketed products and a robust pipeline of promising new product candidates. MedImmune’s state-of-the-art Cambridge site (formerly Cambridge Antibody Technology) is home to around 390 employees, and serves the company’s European hub for research and development.


The Senior CRA participates as a leader (if directed), or supports the operational aspects of the Clinical Trial Team’s activities to facilitate: overall study site management, vendor management, quality assurance, consistency, integration of study data, and the progression of clinical trial deliverables as related to: time, cost, and quality from study concept through study closure.


Accountabilities and Responsibilities:

· Work in collaboration with Clinical Project Management, (CPM), to identify roles and responsibilities of all study team member.

· As directed, oversee protocol development and other critical study documents and templates as appropriate.

· As directed, contribute to the selection and negotiation with CROs and other Vendors

· Participate in protocol and Informed Consent Form review sessions.

· Work collaboratively with all functional areas to facilitate teamwork and communication that will support the success of the clinical study.

· Work closely with Clinical Trial Team to ensure timely resolution of clinical trial project issues, and the ability to ask and obtain direction from more senior clinical operations staff when necessary.

· Must display the ability to facilitate strong external partnerships with vendors, CROs, academic clinics, and other organizations and individuals, to proactively identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure study deliverables to time and quality.

· Employ operational expertise in the preparation of Investigator meetings, monitor training meetings and other meetings. And be willing to create and deliver presentations when applicable.

· Lead or participate in the set up, maintenance and consistent use of any e-clinical components of the study (e.g. IXRS, EDC, CTMS, etc.)

· Contribute to activities as directed , (e.g. defining and testing data checks, system User Acceptance Testing), that will progress the availability of tools and programs that facilitate data capture and validation activities.

· Provide operational expertise to the program manager and input to key documents, (e.g. Clinical Study Report, etc.), and recruitment strategies, as well as contingency strategies for managing risks to clinical operations.