Clinical Monitor GCP QA Specialist
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.
- Ensure operations are compliant with internal procedures and regulatory requirements by auditing Clinical Protocols and associated documents for alignment with the Clinical Assessment Plan, GxP and ICH Guidelines and applicable sections of the FDA Code of Federal regulations.
- Support Key Quality Performance Indicators to drive Operational excellence and problem-solve trends by collection of data and analysis.
- Serve as a QA resource to provide input and guidance to cross-function teams on quality issues and conduct peer review of documentation, as necessary.
- Interpret and provide guidance, coaching, and mentoring to other functions and, where necessary customers on regulatory requirements and expectations.
- Ownership of planning and execution of customer audits related to clinical projects. Responsible for management of customer findings to ensure timely responses are provided.
- Supporting the provision and development of efficient and effective Quality Assurance (QA) systems for improvement of clinical and scientific research studies
- To ensure eQMS, study documentation, and data (paper and electronic) is retained in accordance with appropriate regulations.
- To comply and adhere to GCP guidelines and regulations as required of this role.
Main tasks and responsibilities will include:
- Ensure efficient and effective execution of QA systems in accordance with procedural requirements.
- Responsible for monitoring the clinical trial in compliance with ICH Topic E6 (R2), namely ICH GCP Guidelines and applicable regulatory requirements to verify that:
- The safety, rights and well-being of trial subjects are protected
- Investigators are appropriately trained and supported to complete the proposed clinical trial
- Processes are consistently followed, and activities are consistently documented to ensure high-quality trial conduct and protocol compliance
- Investigational product storage and accountability are correctly maintained
- The reported trial data is accurate, complete, and verifiable against source documents
- The conduct of the trial follows the currently approved protocol/ amendment(s), with ICH GCP guidelines and with the applicable regulatory requirement(s)
- Review unblinded monitor reports and provide effective feedback accordingly.
- Generate comprehensive review reports during study monitoring activities.
- Track and Trend Monitoring activities for studies conducted at the site.
- Attend quality review meetings, such as post database lock data quality meetings, data quality oversight meetings, or metrics updates meetings.
- Collaborate during audits to monitor compliance of internal operations with internal procedures and regulatory requirements (GCP), including documentation such as clinical study protocols and reports, internal audits, and Process audits/ inspections.
- Lead effective GDP and GCP trainings in collaboration with Site QA.
- Collaborate during sponsor audits to ensure successful audit outcome.
- Participate in regulatory Inspections as needed.
- Perform other duties as required.
- Bachelor’s Degree in a scientific field or related
- Minimum 3 years relevant experience in life sciences quality or relevant experience on a regulated field
- Effective written and oral communication skills
- Competent in the use of Microsoft Office packages including Word, Excel, and other systems like eQMS, eQDocs and eDCS
- Previous experience and knowledge of documentation, archiving and training processes within a GCP regulated environment.
- Previous experience of working in a clinical research environment or equivalent experience in another role. Knowledge of the regulatory framework around clinical trials
- Good understanding of Good Clinical Practice (GCP)
- Experience in conducting customer audits against company procedures and regulatory requirements.
- Detail oriented with excellent problem solving and organizational skills.
- Ability to perform multiple tasks and prioritize work to assure business and compliance objectives are met.
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.