Senior Clinical Research Associate – (Sen CRA) – Office Based or Home based (Middlesex)

This award winning fast growing, full service, global CRO that delivers to the world’s leading biotech and pharmaceutical companies are currently seeking a Senior Clinical Research Associate (Senior CRA) to join their organisation. You will be involved in full scale, complex trials across multiple therapeutic areas including – gastroenterology , haematology and endocrinology. As well as having the skills to take responsibility in this role, the organisation is also looking for a personality to match and contribute to a dynamic, positive and goal orientated team.

 

Role

·        – Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits

·        – Organising study Site Initiation Visits (SIVs), clinical monitoring and site management activities

·        – Monitoring trial progress and ensuring that project timelines are met

·        – Ensure procedures are in place for appropriate optimization of patients into clinical trials

·        – Facilitating site contractual start-up and site budget processes

·        – Coordination of site regulatory documents collection

·        – Management of investigator site payments

·        – Point of contact for investigators, project teams and support staff

·        – Delivering onsite training of investigators and staff; in-house project team training

·        – Participation in/presenting in Investigator Meetings

·        – Maintenance of project files including Trial Master File (TMF)

·        – Participation in feasibility research

·        

Qualifications

·        – University degree in Life Sciences, Pharmacy, MD or RN or equivalent degree

·        – 3 years experience of monitoring responsibilities within Phase II/III Clinical Trials

·        – Actively participated in Lead CRA

·        – Experience with infectious disease, gastroenterology, haematology is diserable

·        – Thorough knowledge of ICH/GCP guidelines

·        – Strong team playing, communications and organisational skills

·        – Ability to travel

 

This organisation prides themselves on a exceptionally well structured operational infrastructure which they believe is fundamental to the company’s success. If you are passionate for achievement and are looking for a place to demonstrate your potential, this environment is very supportive and will encourage you to achieve. They will reward you with a strong numeration package, benefits package and guarantee flexibility to reach a perfect life/work balance.

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