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Job Details - Field Based Senior CRA
| Title: | Field Based Senior CRA |
| Category: | Clinical Research |
| Job Type: | Permanent |
| Job Status: | Full Time |
| Salary Range From | 30000.00 |
| Salary Range To | 40000.00 |
| Salary | 40000.00 |
| Salary per | annum |
| Location: | Home Counties - Berkshire |
| Postal Code: | |
| Description: | |
| Company:
Our clients are a large, international biopharmaceutical, specialising in the treatment of conditions such as cancer, degenerative neurological conditions, endocrine and metabolic disorders, cardiovascular conditions, and other conditions with medical needs that are as yet unmet. Role: This is an excellent opportunity for are proven Clinical research associate with a desire to progress to a Senior CRA role within a Biopharmaceutical with an international reputation. This role can also offer the flexibility for field based working for the right person. Purpose of the role: To provide local site and study management and central co-ordination of the monitoring function from feasibility to study completion, across all regions, phases and therapy areas. To oversee the conduct of clinical trials at assigned trial sites, within the agreed time scale, by regular monitoring. Once responsibility has been assigned, the CRA is the primary contact between the trial site and Sponsor. All tasks are conducted in accordance with applicable Policies, Standard Operating Procedures (SOP), Work Instructions (WIs) and conventions, as well as current ICH Good Clinical Practice (ICH GCP) and applicable local regulations. Qualifications: Essential qualifications, training and skills to include: *Biological Science or similar /pharmacy/nursing degree or Nursing qualification. *Significant level of CRA experience or combination of CRA + other relevant experience (e.g. regulatory, clinical QA, pharmaceutical sales, study site coordinator). *Proven track record demonstrating thorough knowledge of ICH GCP and applicable local regulations (e.g. EU/ FDA regulatory requirements for drugs or biologics). *Phase I to IV experience. *Experience of regulatory inspection. *Multinational experience. *Experience in relevant therapeutic areas. *Experience of internal audit. *Involvement in protocol, CRF, other trial related document development. *Understanding of drug development process. *Proficient PC skills: Word, Excel, PowerPoint, e-mail. *Evidence of creative problem-solving skills. *Strong interpersonal skills. *Excellent oral and written communication skills in English; other language as appropriate for country. *Excellent time-management skills. *Excellent organisational ability and flexibility. *Highly self-motivated and proactive, with a keen attention to detail. *Goal orientated, able to effectively prioritize and execute tasks in a high-pressure environment. *Ability to be a team player. *Ability to work from home *Must have current valid driving licence. *Be willing and able to travel (a commitment of up to 70% travel may be required). *Be willing to aid CM in cross-regional resource roles where mutually convenient Desirable qualifications, training and skills to include: *Higher Science degree eg MSc, PhD Additional / How to apply: For more information or to apply, please contact Suzanne on 0845 338 6223 or send your CV to Suzanne@proclinical.co.uk, or apply online via the link below. ProClinical Ltd. specialise in Bio/Pharmaceutical recruitment in the UK and throughout Europe. An approved supplier to major market leading companies, ProClinical have a host of permanent and contract opportunities in Regulatory Affairs, Clinical Research, Medical Affairs, Drug Safety, Quality Assurance/Control, Clinical Trials Supplies and Logistics, Health Outcomes and Economics...etc. If this role is not for you but you are interested in hearing about our other opportunities, register your CV at info@proclinical.co.uk or call 0845 338 6223 for an initial consultation. www.proclinical.co.uk |
| Carreer Level: | Senior |
| Additional: | negotiable |
| Job post will expire on: | July 18, 2008 |
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