Clinical Research Associate

Inivata

Closing Date: 30/09/2021

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.

www.inivata.com

We look forward to reviewing your application!

To apply for this job please visit cezanneondemand.intervieweb.it.