Clinical Project Coordinator
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 save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 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.
- To support project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget
- To comply & adhere to GCP guidelines and regulations as required of this role
Main Tasks and Responsibilities:
- Assist in production and formatting of study documentation e.g. informed consent forms, training materials, file notes, laboratory manuals etc.
- Support set up of vendors.
- Internal risk-based monitoring following first dosing to ensure all study documentation is working effectively.
- Assist with internal data generation such as recruitment and subject status updates, adverse event summaries etc.
- Set up and host Sponsor monitoring visits
- CRA Trial One Training
- Ensure monitoring visit action items are addressed
- Assist Project Managers with close out activities e.g. archiving, reconciliation.
- Manage data query resolution.
- Ongoing clinic query resolution from screening through post discharge following SDV.
- Answer queries during database cleaning.
- Action process improvement initiatives as allocated
- Work with the study team to ensure the Investigator Site File and Trial Master Files are maintained and perform periodic QC of TMF (as per DOC-00433 Trial Master File).
- General support to the Commercial and Project Management groups as needed to win and deliver business
- Support PM Team on Focal Point set up and invoicing.
- Support Database close and lock activities.
- SBIM (meeting minutes).
- Trial One UAT activities.
- Minimum Degree qualification or equivalent
- Relevant work experience in a pharmaceutical company/CRO would be an advantage
In return you will receive a competitive salary, 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.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.