Clinical Trials And Quality Administrator - Re:cognition...

About the Company:

Re: Cognition Health is a leading provider of clinical services specialising in cognitive impairment. We deliver expert clinical care to private patients and are one of the foremost providers of Clinical Trials in the world and deliver award winning medico-legal services. We value people who are dedicated, hardworking and looking to contribute to the growth of the business at an exciting time.

The successful applicant will have access to all Re: Cognition Health’s benefits. On top of this the successful candidate will have the opportunity to work in one of our established clinics around the country.

The Role:

We have an opportunity within the organisation for confident a Clinical Trials and Quality Administrator to join a talented growing team. The position is based in Bristol. We are looking for an ambitious, organised and hardworking individual, willing to take on a range of responsibilities and grow with the company.

You will be providing support and assistance in the administrative management of the clinical trial studies. Working closely with the Study Coordinator, Principal Investigator and Senior Management teams to maintain and organise study files. The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical Trial.

Responsibilities:

• Providing administrative support to the Clinical Trial Coordinator and PI
• Preparing CRFs (Source documents) and other essential documents
• Assist with collating, submitting and tracking source data and data queries to Data Management within the set timeframes
• Maintenance of Investigator Site File (ISF)
• Maintenance of study documents and trial supplies
• Assist with laboratory sample management, including processing laboratory samples
• Assist with pharmacy checks
• Maintaining clinical trial databases
• Support the sites and UK Quality Lead / UK Clinical Trials Director, with audit/inspection preparation for all UK Sites
• Support the UK Quality Lead / UK Clinical Trials Director with the collation/review of documents, with the site team(s), to support with their preparation of audit/inspection responses for all UK Sites
• Support the UK Quality Lead / UK Clinical Trials Director with track to closure/completion, of agreed inspection/audit, Corrective Action and Prevention Action (CAPA) and Effectiveness Check (EC) plans for all UK Sites

Requirements:

• Bachelor’s Degree in a science, technical, health-related field.
• Minimum 1 year of previous or current experience in a pharmaceutical, biotech, CRO setting, or Clinical Trials Administrator experience.
• IT Proficiency (Microsoft Office package)
• Good verbal and written communication skills

Desirable:

• Clinical trials experience in an NHS, academic or commercial setting
• Experience of managing essential documents for Clinical Trials according to ICH GCP
• Experience of using electronic data capture systems, e.g. medidata RAVE

Benefits:

• Continuous professional development
• Private Health Insurance
• Pension Scheme
• Employee Assistance Program
• Life Insurance

Type of Contract: Permanent

Working schedule: 40 hours per week, Full time

Salary: £24,000 - 25,000 per annum, Depending on experience

If you think that you are suitable for this Clinical Trials and Quality Administrator role, please apply now!