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Vacancy details
Vacancy description:
Job Code:
Senior Clinical Research Associate
Job Title:
Senior Clinical Research Associate
Job Category:
Clinical Research
Contract:
Permanent
Discipline:
CRA
Country:
United Kingdom
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
26 May 2008
As a field based Senior Clinical Research Associate you may wish you take up this new challenge and contact us about further details.
The Job:
Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, Company’s SOPs/WPs, applicable regulations and the principles of ICH-GCP
Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of Company’s systems and procedures as appropriate.
Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Provide a benchmark for acting according to Company’s values and act as a positive promoter for the Company.
Responsibility:
Knowledgeable of Company’s Clinical Research SOPs/WPs, ICH-GCP and appropriate regulations and it’s systems.
Recruitment of investigators.
Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:
o Identify investigators.
o Help, when requested, in preparation of Regulatory submissions.
o Design patient information sheets and consent forms.
o Co-ordinate documents translation, verification and back translations where required.
o Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
o Placement and initiation visits.
o Conduct regular monitoring visits in accordance with the Company’s site monitoring SOP/Sponsor site monitoring SOP, as appropriate
o Maintain all files and documentation pertaining to studies.
o Motivate investigators in order to achieve recruitment targets.
o Complete accurate study status reports.
o Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
o Keep the project manager regularly informed.
o Process case record forms to the required quality standards and timelines.
o Deal with Sponsor generated queries in a timely manner.
o Ensure the satisfactory close-out of investigator sites.
o Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
o Ensure correct archiving of files on completion of a study.
o Maintain patient and sponsor confidentiality.
o Assume additional responsibilities as directed by Associate Clinical Project Manager/Clinical Project Manager (CPM).
o Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a CPM/Associate Clinical Project Manager.
o Co-ordinate and/or participate in feasibility studies for new proposals, as required.
Be cost effective.
Participate in mentoring and training new staff.
Assist with marketing the company if and when appropriate.
Required:
Medical/science background and relevant experience.
Ability and willingness to travel at least 50% of the time (international and domestic: fly and drive)
Ability to review and evaluate clinical data arising from aptitude and have the required level of experience in Clinical Research.
Computer literacy required.
Foreign language skills desirable.
Current full driving licence essential.
Good oral and written communication skills.
Eligible to work in the UK
Offered:
Excellent career opportunities
Remuneration according to experience
Field based
Global CRO
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