Clinical Documentation Coordinator

4 days ago

Nottingham, United Kingdom Quotient Sciences Full time

**Company Overview**

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, 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**

Due to growth and expansion, we have an exciting opportunity for a Clinical Documentation Coordinator to join our clinic in Nottingham. Under the direction of the Clinical Laboratory Manager, you will take an active role ensuring study data is collected to a high quality in accordance with ICH-GCP (The International Conference of Harmonisation Good Clinical Practice).

This is an exciting and unique opportunity for you to work in a busy fast-paced environment where no day is the same. Working closely with our Laboratory Technicians and Shipment Coordinator, you will also work together with our analytical and project management team and with our sponsors. Gaining knowledge and experience within the laboratory setting.

**Main tasks and responsibilities will include**:

- Process Biological samples as per Clinical sample processing Manual at busy periods
- Assist in the generation of sample shipment checklists and sample manifests for all sample shipments at busy periods
- Assist in Laboratory set up and label printing at busy periods
- Attend Study Build initiation meetings
- Study build checks for laboratory processes and procedures with the data capture system
- Assist in the production and formatting of study Clinical Sample Processing Manuals
- Assist in the production and formatting of Laboratory File notes
- Assist the Clinical Laboratory Manager with all required Laboratory based study documentation
- Ensure all sample storage temperature graphs are collated and filed appropriately
- Perform sample milestone checks for all studies
- Perform a final check on the Laboratory Site Files prior to Breakdown in the Investigator Site File
- Assist the Clinical Laboratory Manager in all eSource version updates
- Assist in updating Clinical Laboratory SOP’s
- To be involved in database upgrades and PQ/OQ testing.
- Ordering of Laboratory study consumables
- QC of Laboratory source data
- Assist in the organising of the service and calibration of Laboratory Equipment.
- Work in a safe and responsible manner at all times

We are looking for a highly self-motivated individual with experience of working to strict deadlines with excellent organisation skills and exceptional attention to detail.

Working in a highly regulated and hazardous environment, the successful applicant will have a high requirement to follow safety procedures and needing to respond to client demands.

**Laboratory / Sample processing experience preferred**
- Laboratory / Sample processing documentation knowledge preferred
- Experience in a science, health or customer related field preferred

**Company benefits**

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

**_Our Commitment to Diversity & Inclusion_**

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.

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