Clinical Research Associate

3 weeks 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.

**Job Description**:
**Job Holder**: Line Manager: GCP QA Manager

**Job Title**: Clinical Research Associate Location: Nottingham

**Line responsibility for**: N/A

1. Summary of job purpose
- Perform internal monitoring to help assure quality of trial conduct and provide feedback to support continual improvement across clinical operations. The CRA will promote 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
- To comply & adhere to GXP guidelines and regulations as required of this role
- Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role

2. Qualifications and experience required for competent performance
- Minimum degree, HND, or equivalent
- Previous relevant experience of quality conduct in life sciences

3. Main tasks and responsibilities
- 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

1. Additional Tasks/responsibilities
- Support other departments as and when required

4. Job Demands

**The job may involve the following**:

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

This Job Description is designed to summarise responsibilities, assist in benchmarking performance, and provide information for job applicants. It is by no means exhaustive and is not intended to restrict a job holder’s development or level of performance.

The following approvals are required for this document. If using electronic signatures, the approval route must align with the defined roles below.
Role Print Name Signature Date
Employee Click or tap here to enter text.
Line Manager Click or tap here to enter text.
- Tick here if this document will be following an electronic approval route in Veeva. Signatures will be found on an accompanying page.

We are an Equal Employment Opportunity (“EEO”) Employer.

It has been and will continue to be a fundamental policy of Quotient Sciences not to discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This policy applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

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