Permanent Clinical Research Associate
Major CRO
Field based in the North of England
Introduction
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.
Job Summary
Our client is looking for an experienced Clinical Research Associate to join there early phase team This role is field based but would require frequent visits to the Phase I unit in Leeds
As a Clinical Research Associate, you will conduct site monitoring responsibilities for Clinical trials, including Pre-study qualification, Initiation Meetings, Routine, Interim monitoring Visits and Close-out Visits.
Responsibilities:
* Assists with the implementation of Project Plans related to the Clinical Monitoring responsibilities
* Participates in initial and on-going protocol and CRF training at study site
* May serve as the Primary contact for the clinical sites/Sponsor
* May assist with creation of site training materials
* Participates in the generation of study specific monitoring plans
* May participate in the development of Case Report Forms
* May participate in identification and recruitment of investigators, collection of investigator documents and Pre-Study Qualification Visits
* Participates in Sponsor and Investigator/Initiation Meetings
* Tracks progress of projects and identify appropriate actions to achieve target objectives.
* Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
* Ensures the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
* Ensures that the Site Regulatory Documents are complete and current throughout the duration of the trial.
* Ensures that the study compound inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
* Identification and follow up of SAE's at study site for which he/she is responsible
* Assists with training of new employees, e.g. co-monitoring
Education and experience:
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.
Excellent verbal and written communication skills.
Advanced computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
Valid Driver's License.
Previous monitoring experience
Previous early Phase experience
Supplementary Requirements:
Software Competence: MS Office, MS Project
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: Yes
Employment Information:
Employer: CRO
Employment Type: Permanent
Hours: Full time
Location: UK; North of England
Plan Start Date: Negotiable
Benefits: Pension, Healthcare, Car Allowance, Performance related bonus
Keywords:
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, EU CTD, 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 demonstrate the skills the role requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.
