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Senior Clinical Research Associate (SCRA) -Contract
I have an exciting opportunity for an experienced Senior Clinical Research Associate to join a dynamic team based within the East Anglia area.
As a Senior Clinical Research Associate (SCRA) you will work collaboratively with the Clinical Program Manager counterparts and with supervision from the Line Manager on timelines, budgets, resources, vendors and key project deliverables. The SCRA works in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with departmental strategies and goals and represents the functional area on cross-functional Clinical Trial Teams.
*The SCRA must be able to perform all aspects of the CRA I, II and CSA roles.
*Provide site management and monitoring expertise to the clinical program manager and input to key documents, and recruitment strategies, as well as contingency strategies for managing risks to clinical operations.
*Mentor junior clinical team members and serve as a resource for new employees as directed
*Provide input into non-project work, training activities, and development of procedures as required
*Development of Master Study ICF template, Monitoring Plan and other critical study documents
*Work closely with Clinical Trial Team to ensure timely resolution of site management and monitoring issues
*Proactively identify and resolve study site management and monitoring issues.
*Contribute to the selection and negotiation with clinical study sites, Clinical Research Organizations (CROs), and other external vendors (as appropriate).
*Create and deliver presentations pertaining to site focused information.
*Lead or participate in the set up, maintenance and consistent use of any e-clinical components of the study
*Defining and testing data checks, system User Acceptance Testing, which will progress the availability of tools and programs that facilitate data capture and validation activities.
*Serve as a study knowledge expert and help to develop and implement clinical trial best practice; Work with other members of the organization to share knowledge, experiences and best practices.
The successful Senior Clinical Research Associate ideally will have;
*3 years + of on-site monitoring, relevant site management experience and relevant study management experience.
*At least 2 years of prior experience functioning in the capacity of as Lead CRA, Clinical Team Lead or industry equivalent experience.
*2 years for prior experience with EDC and an excellent understanding of clinical data flow
*Proficient in Microsoft Outlook, Word and Excel.
*Demonstrated ability to use consistently all relevant portions of software used by study teams including a Clinical Trial Management System.
*Working knowledge of the requirements to complete all forms of monitoring visits as described above.
*Demonstrated advanced working knowledge of ICH GCP and relevant regulatory requirements and is aware of the appropriate escalation process compliance issues.
*Proven organizational and problem solving/analytical skills in planning and coordinating deliverables.
*Demonstrated leadership skills in a team environment and the ability to function independently.
*Proven ability to prioritize and manage multiple tasks.
*Excellent interpersonal skills and proven ability to facilitate team building and team work.
*Excellent verbal and written communication and presentation skills.
*Excellent knowledge of the spoken and written English language.
The company will provide an opportunity to progress your career as a Senior Clinical Research Associate where you can further develop your skill set. The contract offered may potentially be extended.
For further information on the role or company please contact myself, Nina Matharu at Paramount Recruitment on 0121 616 3477.
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