What are the responsibilities and job description for the Clinical Training Coordinator position at Quotient Sciences?
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.
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 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
When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce 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.
Specifically we will not discriminate on the basis of race, colour, 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 applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
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 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
- Responsible for reviewing with the Onboarding team all required regulatory training including but not limited to CITI: OSHA, GCP and GDP, Trilogy Med-waste and KnowB4 trainings have been completed during scheduled onboarding prior to commencing Clinical Competencies in the Clinic.
- Responsible for conducting delegated training of Clinical Research Technicians on clinical procedures and assisting the Clinical Training Supervisor in ensuring documentation and trainings are up to date for all Clinical Operations personnel.
- Responsible for ensuring subject safety at all times.
- Responsible for ensuring excellent clinical standards within the clinic.
- Responsible for ensuring study data is collected to a high quality in accordance with ICH–GCP
- Responsible for providing support in the development, implementation, monitoring and management of various operational systems by adhering to applicable
- To comply & adhere to GCP guidelines and regulations as required.
- Liaise as required by delegation with functional heads, Director of Clinical Operations, Clinical Training Supervisor and Clinical Leads to identify training needs.
- Complete delegated clinical training for newly hired Clinical Research Technicians and assist Clinical Training Supervisor to manage ongoing Bi-Annual Clinical Competency Re-Evaluations of clinical personnel and required Level 2 Clinical Competency re-trainings as needed.
- Responsible for assessing delegated competencies and communicating with Clinical Training Supervisor of readiness of staff.
- Assist the Clinical Training Supervisor with the validation activities of clinical equipment and procurement of study specific equipment as applicable per study protocol requirements.
- Clinical procedures as applicable under scope of practice for Certified Medical Assistant
- Identify opportunities for change and assist Clinical Training Supervisor and Clinical Leads with implementation of process change.
- Perform ad-hoc duties as required to support ongoing operations.
- Minimum qualifications – Certified Medical Assistant
- Minimum 2 years work experience within a Clinical research environment preferred
- Experience in training colleagues on clinical procedures and processes
- Understanding of the clinical development process and clinical safety documentation requirements
- Proactive approach to GCP and clinical safety compliance
- Experience in a Clinical Research environment preferred.
- Attention to detail, excellent communication and organizational skills
- Experience of Microsoft associated programs (e.g. Excel, Word, PowerPoint)
- Excellent verbal, non-verbal and written communication skills.
- Excellent interpersonal and customer service skills.
When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce 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.
Specifically we will not discriminate on the basis of race, colour, 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 applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
