Company Description
We are a leader in liquid biopsy. Every day we transform the lives of cancer patients and their families through the power of liquid biopsy. Our tests unlock essential genomic information from a simple blood test and allow clinicians to make more informed treatment decisions for their patients.
We are dynamic and innovative, focused on the development of new ground-breaking technologies in a fast-paced and international setting. Our exceptional team of talented and driven individuals work together to combine their energy and expertise in world-class research, product development and commercialization to bring new tests to the patients that need them.
If making a difference is in your DNA and you are ready to join the liquid biopsy revolution, then you could be just the person we are looking for to join our team based in Cambridge, UK!
Position
Role Overview:
The Clinical Research Associate role will plan, implement and monitor the progress of assigned clinical studies and be responsible for the overall clinical operational management. The trials assigned may be either sponsored by Inivata or conducted in collaboration with Inivata partners.
Key Responsibilities:
Responsible for implementation, control and evaluation of assigned clinical projects undertaken by Inivata through day-to-day clinical operational management
Develops and manages compliance with project management and analytical plans, in conjunction with the Sr. Director (Clinical Genomics), Project Lead and collaborator(s)
Design and implement plans for site selection, specimen collection, monitoring (in-house and contracted) and patient enrollment
Develops and reviews study documentation, such as protocols, CRFs and informed consent documents to run GCP-compliant clinical trials, in liaison with the project lead
Supports study budgets, contract negotiations and oversight of clinical service providers
Set-up clinical supplies including lab kits, labelling and supporting documents in-house and in liasing with third party service providers
Coordinate inbound clinical specimen shipments for assigned projects, ensuring accurate requisition documentation
Coordinate specimen accessioning issues with lab operations and clinical sites, acting as point of contact for clinical collaborators
Develops and oversees systems to track projects including all study, investigator and ethical review board information, specimen collection, patient recruitment activity and financial management
Responsible for project documentation, including essential document/TMF management where required, to ensure studies are inspection ready and regulatory compliant
Coordinates with project team of internal staff, service providers, external collaborators and /or Inivata clients
Responsible for training of collaborating investigators, project team and service providers including compliance with project plans, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulations
Provides cover for project leads, clinical staff and may take on other responsibilities as assigned
Establishes strong relationships at sites and with service providers
Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned
Some travel may be required (5-10%)
HIPAA/GDPR Compliance: Position will
Agree to abide by Employment and Confidentiality Agreements and End User Policies
Commit to stay up to date on training requirements for HIPAA/GDPR
Understand the importance of the proper handling and disposal of ePHI and agrees to follow HIPAA/GDPR Regulations
Abide by the requirements for the proper disposal of equipment containing ePHI
Agree to report breaches and the improper handling of ePHI to the Company’s Privacy and Security Officers
Produce and adhere to proper validation documentation
Requirements
Technical Requirement:
Minimum degree in life sciences subject required
Minimum 4 years of clinical research experience, monitoring experience preferred
Familiar with ICH-GCP, IVDD and relevant regulations
Computer literacy (including relevant software, such as Excel, Word, PowerPoint, Adobe plus specific regulatory packages)
Skill requirement:
Excellent English oral and written communication skills
Enjoys working in a regulated environment and willing to comply with Inivata Standard Operating Procedures and Policies
Ability to manage multiple and varied tasks and prioritize workload with attention to detail
Good spelling and proofreading skills
Able to take initiative and work independently; sense of urgency in completing assigned tasks
Pragmatic and practical, highly motivated to ensure that studies meet challenging timelines
Able to identify issues quickly and propose options for resolution
Flexibility towards work assignments, new learning and travel.
Other information
Our Values guide all our activities:
We are BOLD with the delivery of cutting edge science.
We are PASSIONATE we love what we do, our purpose and our impact on patients is clear
We are CARING we care for our patients, our partners, customers and colleagues
Inivata Limited is based in Cambridge, UK.
No agencies please.
We look forward to reviewing your application!