Biomedical Engineering Research Assistant jobs

RDL Scientific are offering an exciting opportunity to join a leading Phase 1 Clinical Pharmacology Unit (Clinical Unit Cambridge) as a Clinical Development Associate (CDA). The CDA will be responsible for supporting Clinical Development Managers on the operational delivery and oversight of multiple clinical studies within the Unit, with end-to-end involvement from protocol development, study set up, study execution and study closeout.

Dependent on prior experience and / or performance in the role, the CDA may also be assigned to lead and manage their own studies.

Duties:

• Support activities ongoing throughout the study such as co-ordinating and minuting study team meetings, producing clinical study timelines, and maintaining study tracking documents.
• Develop, contribute to and review study documentation including Clinical Study Protocols, Informed Consent Forms, Lab Manual, study budgets, contracts, Task Orders and other study documents as required.
• Support the production of complete and accurate documents for the Investigator Site File and ensure and maintenance of the ISF for monitoring and inspection-readiness.
• Support coordination and submission of the required package of documents for approvals to conduct the study, e.g. Ethics Committee and Regulatory Clinical Trial Applications (CTAs), NHS R&D etc., and manage subsequent correspondence, approvals and amendments.
• Support the oversight of study conduct, including risk management and troubleshooting issues.
• Support coordination and submission of the close out of the study, including submission of the End of Trial Notification and End of Study Report summary to the Ethics Committee.
• Ensure compliance with ICH/GCP, regulatory and ethical guidelines, and GSK/CUC SOPs relevant to the role.

Requirements:

• Bachelor of Science or equivalent, or professional qualification in a life science field.
• A basic understanding of the pharmaceutical industry and the clinical development process
• Minimum 1 year experience of working in a clinical study delivery / clinical research environment.
• Able to demonstrate some understanding of clinical trials requirements and clinical trial terminology.
• Competent and confident written and verbal communication in a matrix environment.

Experience (preferred):

• Prior work experience as a study manager, clinical development associate, clinical trial coordinator or other similar role.
• Good knowledge of ICH GCP, GMP and GxP requirements, regulatory and ethical requirements, SOPs and policies.

You must have the right to work in the UK for this role, RDL Scientific are unable to provide sponsorship.

Job Types: Full-time, Fixed term contract

Pay: From £30,000.00 per year

Benefits:

• Company pension
• Cycle to work scheme
• Gym membership
• Life insurance
• Private dental insurance
• Private medical insurance
• Sick pay

Ability to commute/relocate:

• Cambridge, Cambridgeshire: reliably commute or plan to relocate before starting work (required)

Experience:

• Clinical trials: 2 years (required)

Work authorisation:

• United Kingdom (required)

Work Location: In person