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Vacancy details
Vacancy description:
Job Code:
J897661
Job Title:
Clinical Research Associate CRA
Job Category:
Clinical Research
Contract:
Locum/Temporary
Discipline:
CRA, Clinical Study Coordinator, Clinical Trial Administrator
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Surrey, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
An exciting opportunity for someone with experience in clinical trial monitoring within a pharmaceutical company, institution (Hospital) or CRO. Our Client, a growing TOP 20 global pharmaceutical company based in Berkshire are looking to recruit a Clinical Research Associate on a contract basis! This is an excellent opportunity to work within a company with such a strong pipeline, which should not be missed!
Main purpose of the position:
To monitor and progress to completion the pre-clinical and clinical studies undertaken by the I.C.T.R.
Work to be performed:
In all tasks to follow Good Clinical Practice and all aspects of the Company Standard Operating Procedures and to work in close collaboration with the relevant Project Manager(s):
Study Preparation / Set-Up
1. To ensure before study set-up, in collaboration with the Project Manager that all relevant requirements are met and all study-related material is available on site for the study to commence.
2. To attend the pre-study meeting(s) (Investigator meeting and study set-up) and ensure that all relevant personnel at the study centre are familiar with the requirements of the study protocol, GCP and local regulations; monitoring requirements and procedures (including likely frequency of monitoring visits); the case report form and its completion.
3. To participate in the set-up of the pharmacy at the study centres and in doing so, ensure that storage conditions for therapeutic units are adequate and that adequate systems will be followed to guarantee the accountability of units.
4. To ensure that study personnel know the name and telephone number of the company person to contact in case of emergencies and the procedure to follow in the case of any serious adverse events.
5. To liaise wherever appropriate, with clinical pathology laboratories to ensure the adequate preparation for, and successful completion of, all analyses (including provision for storage of samples at site if applicable).
During the Study
According to GCP and Company SOPs carry out regular monitoring visits in allocated centres:
1. To plan visits in advance according to the activity of the centre (respecting at least the minimum requirement) and ensure optimal use of time at site through adequate planning and communication, ensuring that relevant case report forms, source documents and any other necessary documents will be available on the appropriate day.
2. To meet study site personnel to resolve any outstanding queries, discuss study progress and any problems encountered, in particular pharmacovigilance.
3. To identify any protocol deviations and discuss them appropriately with the Investigator.
4. To cross check all records of serious adverse events with pharmacovigilance forms.
5. To check that each page of the Case Report Forms has been correctly completed, and in particular ensure that informed consent has been correctly documented, protocol deviations or patient exclusions are noted, visit dates are correct and all necessary data has been correctly completed, checking, where necessary, against relevant source documents according to the pre-defined list.
6. To ensure that Case Report Forms requiring corrections are dealt with by the investigator/co-investigator at the earliest opportunity. To ensure that these corrections are made on all copies, initialled and dated.
7. To check that the Investigator Site File is up to date on a regular basis.
8. To deal promptly and efficiently with any Data Clarification Forms issued during the course of the study.
9. To meet the investigator Wherever possible, before leaving the study centre to discuss the progress of the study.
10. To ensure the adequate dispatching, storage and accountability of therapeutic units and perform pharmacy visits on a regular basis.
11. To ensure Where appropriate that any equipment on site used for study-related purposes has been adequately calibrated, monitored, serviced and maintained.
12. To complete, for each monitoring visit, the relevant sections of the scientific module in SETHI.
13. To compose, using SETHI, a formal trip report for each monitoring visit and forward it as soon as possible to the Project Manager with a copy to the relevant departments.
14. To meet and communicate with the relevant Project Manager(s) on a regular basis to discuss study progress and ensure that any queries that have arisen form study sites are dealt with in a prompt and efficient manner.
15. To ensure that all necessary steps and checks are made to ensure that all case report form pages and data clarification forms are sent for medical review and to central data management with the minimum delay (in all cases respecting the pre-defined timelines).
16. To assist the Project Manager with the follow-up of financial conditions related to all aspects of a study.
17. To ensure regular pharmacovigilance of studies and, under the supervision of the Director of I.C.T.R. or the Clinical Research Manager, collect the relevant information so that cases are declared to the Department of Health as quickly as possible.
After the Study
1. To assist the Project Manager with the closure of study centres and ensure all documents and equipment are retrieved in accordance with SOPs.
2. To ensure that any data, or other queries arising are dealt with as promptly as possible.
Keywords: Clinical Research Associate CRA Berkshire Contract
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