Pop science is delighted to offer an opportunity with one of our partners in Central London who have recently launched a new CRO to add to their continued success within the industry.

Uniquely you will have the backup and support of a highly regarded institute as well as a committed and enthusiastic team of colleagues.

Having it's own independent clinical research and development facility makes this opportunity truly unique and already well known for excellent collaboration with leading research institutions and universities in the UK and around the world.

This role is for a Clinical Research Associate (CRA) II will be responsible for performing and coordinating all aspects of clinical monitoring and site management, ensuring that country and site targets are achieved, in compliance with ICH/GCP, SOPs and all other applicable regulatory requirements. Preferably this candidate can speak French and or Spanish. The role is office based in London. 

Key Responsibilities:

• Oversee all aspects of study site management including; collation of trial related documentation (site contracts, consent documents, letters of agreement, confidentiality agreements), tracking or site performance, status reports to ensure high quality data resulting in consistently low query levels in good Quality Assurance reports.
• Assists with execution of site contracts.
• Involved in recruitment of potential Investigators, preparation of Ethics Committee/Independent Regulatory Board (EC/IRB) submissions, renewals, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks.
• Conduct pre study visits and site initiation meetings; training investigators and other trial staff in the protocol, data collection methods, completeness and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and SOPs.
• Track patient recruitment and report on site issues/strategies to increase patient accrual into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
• First point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing studies.
• Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
• Ensure maintenance of project site files including:
  • ethics committee approvals and reports,
  • curricula vitae of investigators and study personnel,
  • training/delegation log
  • clinical documentation is current
  • lab reference ranges are current
  • investigator and site correspondence log
  • schedules of payment.
  • Conducts remote monitoring and site visits - assessing protocol and regulatory compliance, and reporting conduct using applicable documentation.
  • Ensure site staff are trained in the subject knowledge and protocol specific procedures and are ICH-GCP compliant.

• Comply with all applicable laws / regulations of each country in which we do business.
• Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians.
• Report, write narratives and follow-up on legal, compliance and ethical violations in a timely manner.
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Input to creation of monitoring plans
• Organise and make presentations at Investigator Meetings
• Provides support and confer best practice to more junior colleagues and CRAs as necessary.
• Create and deliver company specific training and contribute to process development.

Desired Skills and Experience:

• Proven leadership/supervisory experience
• Life science or other relevant degree
• Excellent organisational skills
• Excellent interpersonal skills
• Good problem solving abilities
• 3-4 years CRA experience which must include pre-study, initiation, routine monitoring and close-out visits)
• Experience of working in observational trials
• Proven ability to develop and update working practices
• Flexible and effective communication and negotiation skills
• Ideally a strong understanding of cardio vascular disease and treatment
• Ability to monitor sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

Candidates will need to have current and valid eligibility to work in the UK in order to be considered for this role.