Covance Senior Clinical Project Administrator - Berkshire in Maidenhead, United Kingdom
Covance are looking for two Clinical Project Administrators in the Berkshire / Surrey area to be client-dedicated with a prestigious Pharmaceutical company. These roles are both permanent, full time and office based.
To provide comprehensive support to the clinical project team for the set-up and administration of clinical trials ensuring adherence to protocols and quality of information received, in line with Good Clinical Practice (GCP) and company Corporate and Local Standard Operating Procedures (SOPs).
To achieve success it is critical for the CPA:
To provide pro-active management of all administrative aspects of the set up and conduct of clinical trials.
To provide administrative support and focal point of contact as defined above for the Regional/Local Clinical Project Leaders (CPL), Regional Trial Manager (RTM), Start-Up/Regulatory Team and a team of Clinical Research Associates.
To prioritise and organise a varied workload for different team members who sometimes have conflicting priorities.
The job also requires close liaison with the Business Support Assistant, Cluster System Experts, and Medical Affairs contact persons.
A CPA may be given responsibility for specific specialist activities within the CSU, for example back-up specialist roles (like safety, support of CTA-RM and start up team), website support, archiving, etc.
Key Accountabilities :
Toset up, manage, keep up-to-date the local trial master files in association with the CPL, Start-Up/Regulatory Team and Clinical Research Associates (CRA) in accordance with the company Corporate and Local SOPs for filing of trial documents in such a way that any relevant information can be presented promptly during internal or external audits.
To assist the CPLs and Start-Up/Regulatory Team in the preparation of Essential Documents required for timely study set up.
To assist the CPLs and CRAs in the maintenance of trial Essential Documents throughout the lifetime of the study
To submit initial Clinical Trial Application packages and amendments to local authorities and Medical Ethics Committees in close cooperation with Start-Up/Regulatory Team
To prepare the local trial master files for archiving at the completion of the study.
To ensure the efficient and accurate administrative processing of forms concerning datacollection, payments and other materials with regard to clinical trials. Activities are based on the guidelines as described in company Corporate and Local SOPs.
To be an internal focal point for the Clinical Research Associates
To communicate with external relations on a professional level.
To communicate with all relevant inter-company contacts: provide adequate information, consult the right persons in case of problems and make a positive contribution to the decision making process.
To co-ordinate the investigator contacts for investigator meetings and related activities.
Management of resources:
Accurately raises Purchase Requisitions with information provided by requestor and ensure such information is correct
Updates systems in a timely way to reflect the current status of purchase orders and any deliveries of goods and services
Attends to invoice system requests and queries quickly and efficiently
Prepares correct overviews of payments to be done to study sites based on real work done by these study sites
Be a partner for the Team Manager with the assignment of studies among CPA group
In case of new comer CPAs: to train well these CPAs (being able to work independently on the studies)
To chair CPA meeting to discuss all relevant issues and take care that any action points are done according to set timelines
Education / Qualifications
No specific education is required
Ideally at least 1 - 2 years experience within in a Clinical Administration role
Knowledge of and experience with GCP and other regulations in force; ability to learn and apply SOPs and quality control.
Good IT skills in MS (Word, Excel, Powerpoint, Outlook) and other company applications are essential.
Job Number 2019-27131
Job Category Hidden (54286)
Position Type Full-Time
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