Clinical Research Associate

6 months ago

Nottingham, United Kingdom Quotient Sciences Full time

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,300 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role
We have an exciting opportunity for an internal monitor / Clinical Research Associate (CRA) to join our QA department in Nottingham. This is a full-time role, however other working arrangements will be considered.
The successful applicant will be responsible for performing internal monitoring to help assure quality of trial conduct and provide feedback to support continual improvement across clinical operations.
The internal CRA role promotes the maintenance of Good Clinical Practice across all aspects of the clinical trial process via the performing of structured quality checks on high risk procedures.
You will be required to comply and adhere to GXP guidelines and regulations as required of this role whilst working effectively with colleagues across all functional areas to achieve objectives whilst maintaining good working relationships.

**Other responsibilities will include**:

- Perform structured quality checks on high risk procedures including, but not limited to:

- Subject eligibility/informed consent/QC of data (secondary QC)
- Dose administration
- Dose decision
- Support the collection and analysis of study quality metrics
- Attend and contribute to study quality review meetings
- Help ensure learnings from studies are implemented across future studies - Support implementation of change
- Perform and support deviation investigations and root cause analysis
- Participate in performing self-inspections (internal audits)
- Support Customer study audits
- Co-monitor independent CRAs

We are looking for an internal CRA who will thrive in a fast-paced working environment, with the ability to multiple tasks simultaneously.

**Skills and experience required**:

- Minimum degree, HND, or equivalent
- Previous relevant experience of quality conduct in life sciences
- Proven ability to work autonomously, to seek answers and self-motivate
- Proven ability to adapt both communication styles and formats, to ensure a consistent, clear
- message
- Proven ability to work within a team, to promote an atmosphere of respect, support and continual learning

Job Demands

**The job may involve the following**:

- Very high concentration of work
- Strict and tight deadlines
- Working in a hazardous environment with high requirement to follow safety procedures
- Having to juggle a range of tasks/issues simultaneously
- Working outside normal working hours
- Needing to respond to client demands

Application Requirements

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

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