Clinical Research Associate (CRA)
Heather 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 Company: Our client is a global pharmaceutical company with a large presence and multiple sites in the UK. They produce innovative medicines across a range of therapeutic areas to enhance the health and lives of their patients.
The Location: Role offers remote working but ideal location would be in the Midlands or the London area.
The Role: 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.Responsibilities:
- Contributes to the selection of potential investigators.
- In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. May include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
- Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management principles.
- Confirms that site staff have completed and documented required training appropriately, including ICH-GCP training.
- Ensures the sites are inspection ready at all times.
- Actively participates in Local Study Team (LST) and National Investigators meetings, as applicable.
- Initiates, monitors and closes study sites in compliance with Procedural Documents.
- Shares information on patient recruitment and study site progress within the LST.
- Drive performance. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
- Updates CTMS and other systems with data from study sites as per required timelines.
- Manages study supplies (ISF, etc), drug supplies and drug accountability at study site.
- Prepares study drug for destruction, if applicable.
- Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSM the correct timing and type of visits.
- Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations.
- Good medical knowledge and ability to learn relevant Therapeutic Areas. - Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Excellent attention to detail.
- Good written and verbal communication skills.
- Good collaboration and interpersonal skills.
- Good negotiation skills.
- Ability to travel nationally/internationally as required.
- Valid driving license.
- Ability to work in an environment of remote collaborators.
For more information or to apply for this position, please contact Heather on 0191 3848905 or by email on email@example.com. Alternatively, please click on the link below to apply online now. 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 46755 in all correspondence.