Clinical Project Associate

Location

Cambridge, Cambridgeshire | United Kingdom

Job description

We are seeking a highly motivated and detail-oriented Clinical Project Associate to join our dynamic team. This is a home-based role with some travel to our offices in Cambridge (UK). The ideal candidate will play a crucial role in supporting the clinical project team in various activities to ensure the successful execution of clinical trials and research studies. 

Primary responsibilities of the position

Protocol Development:

• Assist in the drafting and review of clinical study protocols.
• Contribute to the development of study-related documents and ensure compliance with regulatory requirements.

Clinical Study Design:

• Provide support in the design and planning of clinical studies.
• Collaborate with cross-functional teams to ensure study objectives are met.

Documentation:

• Maintain accurate and up-to-date documentation for clinical trials.
• Assist in the preparation and submission of regulatory documents.

Research:

• Conduct literature reviews and stay updated on relevant advancements in the field.
• Contribute to the identification and evaluation of potential clinical sites and investigators.

Meeting Coordination:

• Coordinate and schedule meetings with internal and external stakeholders.
• Prepare meeting agendas, documents, and minutes as necessary.

External Partner Liaison:

• Collaborate with selected external partners and vendors.
• Ensure effective communication and coordination with external entities involved in the clinical project.

Essential skills & Experience:

• Bachelor's degree in a relevant scientific or healthcare discipline.
• Experience with diagnostic clinical trials

• Working knowledge of ICH GCP and ISO standards (20916 or 14155) and regulatory requirements for IVD’s
• Experience of working within a regulated environment
• Experience of audit situations
• Experience coordinating with external study sites
• Ability to flex work hours as needed to work with colleagues in both California and the UK
• Ability to occasionally travel to Boston (USA).

Benefits:

• Healthcare Cover, including optical, dental and worldwide travel
• 25 days annual leave, with additional 3 days off for Christmas
• Life Insurance
• Employee Assistance Programmes
• Pension
• Income Protection
• Enhanced sick leave
• Enhanced parental leave policies

Apply now.

Biocrucible do not discriminate, we are interested in your skills, experience and nothing more. If you require accommodations or adjustments to complete the application or interview process, please contact [email protected]

We look forward to speaking with you.

Job tags

Salary