Clinical Officer - Ruislip

Description

Responsibilities include:

Project managing clinical trials (including Bioequivalence and Therapeutic Equivalence studies) of all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring that GCP, regulatory requirements and relevant SOPs are met.

Preparation (where applicable) and review of study essential documents including monitoring plan, protocol(s), Informed consent, CRF, IMPD, IB and other clinical study related reports as per Regulatory guidelines.

Ensuring the project timelines and monitoring the study progress.

Liaising with the CRO in finalising the protocol and other study related essential documents.

Selection and communication with the monitor/auditor.

Assessing the monitoring/auditing report for the CRO provided by the monitor / auditor.

Archiving the clinical study report, TMF and other study related documents.

Liaising in the selection of the CRO in association with GCP consultant.

Coordinating with the Project manage in managing sponsor oversight of clinical trials.

Creation and maintenance of Trial files, including the trial master file and oversight of the site files (such as show file).

Assurance that personal and confidential information of study subjects is restricted to those entitled to know.

Data collection and management, collection of source documents, assessment of CRFs, filing and archiving, managing monitoring visits and dealing with queries.

Close out of the clinical trial, audit preparation/assessment, trial closure, communication with authorities and other disciplines involved.

Assessment of CTD module 5 documentation for submission to EU regulatory authorities.

Preparation/assessment of CTD modules including non-clinical overview (2.4), clinical overview (2.5), clinical summary (2.7) and providing/liaising with experts for statements.

General Administration work related to the trial and managing all external and internal communication activities

Skills required to apply:

Must have previous experience in project managing Clinical Trials (bioequivalence and therapeutic equivalence).

Experience in writing and assessing protocols / other study related essential documents.

Must have full knowledge and understanding of GCP, Bioequivalence and bio-analytical guidelines.

Ensuring they are kept up to date with current EU and ICH guidelines.

Excellent communication skills (oral and written) and interpersonal skills.