Senior Clinical Research Associate - Co. Development duties

1st IT People Ltd and 1st Pharma people
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LYD - 103

Job Description

Perm: Cambridge Based, International Senior Clinical Research Associate – Minor Proposal Development Duties

Contact Information:
Lee Dunn
Tel: +44 (0) 207 255 6665
Lee.dunn@1st-pharmapeople.com
http://www.1st-pharmapeople.com


Job Summary:

In this role you will be a primary source of guidance and reference for Clinical Research Associate\'s alongside normal duties of: Site monitoring, Site initiation and selection. Closing out studies and sites, Ethical submissions and amendments
This position will be working across industry leading therapeutic areas across Europe and across all 4 Phases of clinical study

Offers:

In this position can attain a very competitive salary of £35,000.00 to £40,000.00 along with addition benefits like: Mobile phone, Health insurance, pension, etc. International studies are in place across all key phases. Big named client are awaiting your details and skills for their studies in the areas of Oncology, Immunology, Respirator, etc.

Candidates:

Candidates will need a Life Sciences Degree or Nursing background in Clinical Trials. You will also need at least 2 years previous experience monitoring of clinical trials here in the UK with proven study start-up and close-out knowledge being very valuable. EU based experience is acceptable but only with UK monitoring experience to back it up.
A valid visa will need to be in place if needed and a valid UK or international driving is essential and non-negotiable.

Responsibility Brief:

In Brief the Senior Clinical Research Associate will be responsible for: The review / preparation of draft clinical study protocols, draft Investigator Brochures, Case Report Forms for clinical studies and draft patient/subject informed consent forms for clinical studies. You will also be responsible for: The review / preparation of draft Ethics Committee submissions for clinical studies, periodic project progress reports for clients, review / preparation of Standard Operating Procedures and monitoring of clinical study sites as appropriate, including pre-study, initiation, monitoring and close-down meetings with clinical study investigators. CRAs will also be involved in: The identification of clinical investigators, management of the Trial Master File for clinical studies as per GCP, management of the creation and maintenance of study-specific forms, management of the creation of Investigator Site files, management of the collation and copying of documents for Ethics Committee submissions and management of the archiving of study documents at the close of a project. Additional duties will be to organise and plan study-related meetings, handle telephone and other enquiries from study site staff and clients during a study, as appropriate and the management of the reporting of adverse events, as appropriate.


If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.

This company is acting as an Agency and/or Employment Business

Clinical Research, CRA, Clinical Research Associate, Study Manager, Study Management, Project Manager, Clinical Study, Clinical Studies, Clinical Trial, Clinical Trials and Clinical Development, Phase I, Research Physician, Medical Doctor, ICH GCP, Good Clinical Practice, GCP and Drug Development

Apply for this job online or by email

Salary

£40000.00 p/a

Contact Name

Lee Dunn

Telephone

Always mention ujob.co.uk when applying by phone or post !

0207 255 6665

Email

Click here to apply for this position by email

Location

Sector

Medical Scientific

Recruiter

1st IT People Ltd and 1st Pharma people

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Senior Clinical Research Associate - Co. Development duties

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