Russell Oakley is recruiting for a Clinical Research Associate to join a leading biotech company, working field based from home on a contract basis for 12 months in the first instance.
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated centres and are active participants in the Local Study Team(s). The CRA works in close collaboration with other CRAs and the Local Study Team to ensure that quality and study milestone commitments are achieved in a timely and efficient manner for their allocated centres.
The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies according to the company's Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations and delivery according to the commitment in the individual trials.
The main purpose of the role will be to:
· Obtain and maintain essential documentation in compliance with ICH-GCP, the company's Procedural Documents and local regulations both in Trial Master File (TMF) and Investigator Study File (ISF).
· Actively participate in Local Study Team meetings.
· Contribute to the selection of potential investigators.
· Train, support and advise Investigators and site staff in study related matters.
· Contribute to national Investigators meetings.
· Initiate, monitor and close study sites in compliance with the company's Procedural Documents. Share information on patient recruitment and study site progress within Local Study Team.
· Drive performance at the sites. Proactively identify study-related issues, solutions and escalate as appropriate.
· Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
· Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and CA&A.
· Provide the required monitoring visit reports within required timelines.
· Work with Data Management to ensure quality of the study data.
· Ensure compliance with the company's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
· Experience in Oncology
· University degree and/ or equivalent, preferred in biological science or healthcare-related field.
· Fluent knowledge of spoken and written English.
· Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
· Ability to travel nationally as required.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41838 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 17th April 2018
- Expires: 15th May 2018
- Reference: CL41838