Clinical Project Associate
6 months ago
**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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