Job Description
Biocrucible is in our early growth phase, and you will be part of shaping the future.
We aim to develop proprietary molecular detection technologies deploying ultra-rapid isothermal nucleic acid amplification that enable near-patient and at-home testing for infectious disease or genetic indications.
This is a home/field based hybrid role with time at our Cambridge offices. This role is offered with an initial 6-month contract.
Summary:
The primary purpose of the CRA is to review the progress of a clinical performance study at clinical study sites, ensuring that it is conducted, recorded and reported in accordance with the CPSP, written procedures, Good Clinical Practice (GCP), regulatory requirements and Biocrucible Standard Operating Procedures (SOPs). Ensuring the clinical study is performed such that the subjects’ rights, safety and well-being are protected and that the clinical study data are reliable.
Primary responsibilities of the position
- Responsible for clinical study monitoring, visit sites regularly to execute monitoring activities and write monitoring visit report based on requirements from protocol, monitoring plan, SOPs and GCP.
- Responsible for planning sufficient supply of study materials (reagents, consumables, and files) to each site, and all materials in safe and good storage.
- Raise up study & site issues in a timely manner to CSL and execute with site and investigators for correction & improvement if deviations against protocol or compliance, ensuring all process in recorded appropriately and study data traceable along all the procedures.
- Execution of site training, including protocol, study SOPs, site files and records, database and date entry requirements, and testing workflow training (by collaborating with PD and service team).
- Monitor site proficiency testing and pre-study testing, ensuring site are familiar and proficient with protocol and study procedures.
- Execute site close-out monitor and archive all procedure files and data results at each site according to SOP and GCP requirements.
- Support CA function during audits e.g. BIMO, Pharma partner, FDA.
- Liaises with the Clinical Study Leads (CSL) for relevant projects.
- Mindset of customer orientation, capable of retaining good relationships with external investigators.
- Business travel (up to 70%).
Essential skills & Experience:
- 2-3 years’ experience as CRA for IVD, MD or pharmaceutical clinical trials
- Working knowledge of ICH GCP and ISO standards (20916 or 14155) and regulatory requirements for IVD’s
- Experience of working within a regulated environment
- Experience of audit situations
- Experience coordinating with external study sites.
Apply now.
Biocrucible do not discriminate, we are interested in your skills, experience and nothing more. Please contact us If you require accommodations or adjustments to complete the application or interview process.
We look forward to speaking with you.
Job Type: Fixed term contract
Contract length: 6 months
Salary: £40,000.00 per year
Benefits:
Schedule:
- Flexitime
- Monday to Friday
Education:
Experience:
- clinical project management: 1 year (preferred)
Work Location: On the road
Reference ID: CRA001