Permanent Senior Clinical Research Associate
Office based in the North of England or home based
Our client is one of the world's largest, and well respected drug development services companies with more than 11,000 employees in 60 countries. Our client has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today. With continued growth and investment this Global CRO is looking to appoint an experienced CRA to join their expanding UK team. If you're looking for a diverse and stimulating work environment, one where your unique talents and skills can have a tremendous impact, you'll find it here, our clients diverse, collaborative and challenging environment^can change the course of your career, seeking to promote a balance between your personal life and professional life you will be in an environment that will allow you to learn, grow and achieve.
Our client is looking for an experienced Senior Clinical Research Associate / CRA to join there early phase team This is a field based with frequent visits to the Phase I unit in Leeds
As the Senior Clinical Research Associate, you will manage all aspects of site monitoring responsibilities for Clinical trials, ICH guidelines and GCP, including Pre-study qualification, Initiation Meetings, Routine, Interim monitoring Visits and Close-out Visits. The Senior CRA may serve as Lead CRA and a resource for internal and external clients.
• Serves as lead CRA for a protocol or project. As lead CRA, trains other CRAs on study specifics, ensures consistency at study sites and leverages best practices. Responsible for overseeing CRA performance, reviewing trip reports for content and timeliness.
• May manage/assist with complex clinical projects and lead project teams
• Serves as Project Manager for small-mid sized studies
• Assists with Bid Defense's, as assigned
• Develops contingency plans and alternate strategies
• Responsible for coordinating initial and on-going protocol, CRF and monitor training.
• Fiscal responsibility for tracking the monitoring expenses against the project budget
• Create materials for site reference manual^and other site training materials
• Generates study specific monitoring plans
• Participates in the development of protocols and Case Report Forms
• May participate in identification and recruitment of investigators, collection of investigator^documentation, pre-study qualification visits and site management responsibilities.
• Organizes and delivers presentations at Sponsor and Investigator/Initiation Meetings.
• Tracks progress of projects and initiate appropriate actions to achieve^target objectives.
• Ensures the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
• Identification and follow up of SAE's at study site for which he/she is responsible
• May present at Investigator Meetings
• Conducts training and development of new employees
Current Institute of Clinical Research status: Registered / Professional Member level.
University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
Thorough knowledge of ICH guidelines, GCP and the clinical trial process.
Thorough knowledge of the drug development process.
Demonstrated ability to independently manage complex clinical projects.
Excellent verbal and written communication skills.
Advanced computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
Valid Drivers License.
Previous monitoring experience
Previous early Phase experience
Software Competence: MS Office, MS Project
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: Yes
Employment Type: Permanent
Hours: Full time
Location: UK; North of England or Home based
Plan Start Date: Negotiable
Benefits: Pension, Healthcare,^Car Allowance, Performance related bonus
MS Office, Medical Affairs, KOL, publications, first in man, early Phase, lifecycle, Clinical Research, Clinical Operations, Clinical R&D, CRA, CTM, CTA, GCP, Site Manager, Monitor, Manager, Study Manager, EUCTD, ICH GCP, Project Manager, Clinical Study, Clinical Programme, Feasibility , Essential Documents, GCP, SOPs, Compliance, Training, Investigator Meeting, REC, Research Ethics. R&D, Trust, SMO, Site Manager, Quality Control, QC,EDC
Assigned Consultant: Matthew Pike at CSL Recruitment on 01932 234685
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs, applicants will only receive feedback if they demons