Senior Clinical Research Associate

Upsilon Global Ltd ,
London, Greater London
More Details
Salary: From £40,000 to £55,000 per annum + £5,000 car allowance + benefits

Overview

Job: Senior Clinical Research Associate – reduced travel Location: London, United Kingdom Salary: Extremely Competitive Car Allowance and benefits Upsilon Global are proud to be partnered with a multi-national organisation as they continue to expand their presence within the European market, by appointing an experienced Clinical Research Associate to work within their London office. The successful candidate will be presented with the opportunity to focus on complex projects, within the field of rare diseases, gene therapy and transplantation, working with a dedicated, industry leading team. In return for a positive and passionate attitude, the successful SCRA will join an organisation with a fantastic reputation within their field, having successfully delivered on more than 5,000 projects across six continents since company conception. Main Responsibilities (to include but not be limited to): · Independent and proactive co-ordination of clinical research/project monitoring and monitoring related activities, including the following: · Familiarisation with Study Protocol, IMP, CRF, study specific procedures, ICH-GCP and appropriate regulations Review of SOPs / SSPs · Attending training sessions as necessary · Investigator selection / Pre-Study Visits · Preparation of Clinical Regulatory Document Packages (CRDP) prior to IMP release to sites · Managing translation and QC of study documents · CRA attendance at 'mock' SIV presentations before performing on site SIV · Scheduling and conduct of partial SIVs and full SIVs · Conducting Site Initiation Visits and training of investigators/site staff · Conducting GCP Monitoring Visits in accordance with applicable SOPs/SSPs - Remote monitoring (ongoing review of EDC between MVs) at any sites active and enrolling patients · Preparation and delivery of Monitoring Visit Reports to assigned report reviewer · Maintaining all files and documentation pertaining to study site visits · Compliance in use of Trial Management systems · General site support / site management activities to ensure the site has all equipment and information needed to perform the study · Communicating study issues with Project Manager / CRA Manager · Ensuring study drug is stored and accounted for in accordance with applicable SOPs/SSPs · Participate in monthly CRA calls, frequency may be revised based on enrolment in the trial. · Escalating significant non-compliance issues to Project Manager / CRA Manager Processing case record forms to quality standards · Assisting Project Manager / CRA Manager and the study site in resolution of data queries in a timely manner · Coordinating the close-out of investigator sites · Co-operating with QA/regulatory personnel during audits and inspections Provision of related additional services not specified in the above list may occasionally be requested. Education: · Educated to degree level in Sciences/Life Sciences Qualifications: · Minimum 2 years’ experience of independent monitoring · Fluent in English · Strong communication and interpersonal skills · Valid driving licence · Ability to work at least two days per week in the London office This job was originally posted as www.totaljobs.com/job/89803203

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