CRA

An exciting opportunity has arisen for an experienced Clinical Research Associate (CRA) to join a privately-owned full service global CRO. This role will be based in Montreal on a permanent basis. We are seeking an experienced CRA to work with the project teams responsible for conducting clinical studies to agreed timelines on behalf of clients, under the supervision of the Project Manager/CRA Manager.

Job Responsibilties:

• Conducts and documents Pre-Study Visits (PSVs), Study Initiation Visits (SIVs)/Qualification Visits (QVs), Monitoring Visits (MV) and Closedown Visits (CV) as per the company's SOPs
• To monitor and report on Investigators adherence to approved protocol/amendments and on study conduct at each study site
• To ensure that the Investigator maintains all essential documents and that study related documents, including but not limited to source documents and case report forms, are complete and accurate
• To assist with feasibility studies
• Manage timely compilation and submission of Ethics Applications and assist in Regulatory applications where required
• Conduct telephone calls to investigator sites to evaluate potential patient eligibility and enrolment, and to follow-up on any outstanding issues
• Assist with investigator meetings through the preparation, assembly and shipment of training materials
• Co-ordinate the collection of essential documentation in accordance with ICH/GCP
• Identify, document and report SAEs according to ICH/GCP guidelines and local regulatory requirements, within required timelines and follow-up as required
• Conduct final IMP reconciliation, and arrange return of unused IMPs to the sponsor
• Be responsible for monitoring and maintaining IMP accountability at investigator sites
• Prepare site visit reports and status reports, document site actions in follow up letters/email
• Take telephone calls from team members, investigators and sponsor. Document and follow-up these calls
• Assist Project Manager/CRA Manager with establishing and implementing the query resolution process
• Gain an in-depth understanding of the study protocol, CRF and related procedures
• Develop good working relationships with investigator site personnel and provide support, training and motivation Clinical Research Associate (CRA)
• TMF filing and review, as required
• Assist with general project administration
• Be responsible for filing of documentation regarding designated sites
• Adapt protocols/informed consent forms to country specific requirements
• Develop/implement project specific monitoring tools and tracking forms under the direction of the Project Manager/CRA Manager Description

Skills and Requirements:

• The role will require you to be educated to degree level or equivalent in a scientific field with proven CRA experience, preferably within a CRO or a pharma company
• a full driving licence together with a willingness to travel.
• A very strong understanding of the clinical process (particularly Phase II & III) and the ramifications of change to one or more study assumptions including timeline. Previous proposal experience is preferred
• Excellent planning/organizational skills and ability to prioritise and multitask
• Ability to develop effective cross-functional relationships
• Results orientated
• Excellent communication, relationship building and interpersonal skills
• Able to work with autonomy
• Ability to order and prioritise tasks
• Computer Literacy (Word, Excel, PowerPoint, Outlook Express)
• Numeric and budgeting skills
• Good attention to detail This is an exceptional opportunity within a career driven and progressive organisation offering excellent salaries and benefits.

To Apply:

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 call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
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.