Clinical Research Associate
A multinational Contract Research Organization based in London is recruiting for a dynamic Clinical Research Associate and Senior Clinical Research Associate to join their team. If you're interested in making changes to medicine then this might a role to consider.
- Performs all site processes including site qualifications, site initiation, interim monitoring, site management. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
- Act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned.
- Chart abstraction activities and data collection
- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied
Skills and Requirements
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
- Ability to manage required travel of up to 75% on a regular basis
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani on 02038542629 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.