Clinical Project Associate

2 weeks ago


Cambridge, United Kingdom Biocrucible Full time

**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

We look forward to speaking with you.



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