Company: CK Clinical
Closing Date: 01 Nov 16
Salary (£): Negotiable
Russell Oakley is recruiting for two Clinical Research Associates to join a company in the pharmaceutical industry, working field based on a contract basis for...
Russell Oakley is recruiting for two Clinical Research Associates to join a company in the pharmaceutical industry, working field based on a contract basis for 12 months initially. The regions of cover will be Yorkshire and the West Midlands.
The main purpose of the role will be to
- Manage allocated study sites to ensure that timelines, recruitment and quality standards are met on all clinical trial projects.
- Manage 10-20 sites across a variety of projects and therapeutic areas.
- Manage study sites to ensure investigators fulfil study contracts with respect to recruitment and data quality.
- Maintain awareness of ICH GCP, SOPs and regulatory requirements and ensure adherence by site staff.
- Foster good relationships with investigators, site staff and key opinion leaders to raise company profile and ensure full participation in studies
- Contribute to the monitoring of safety for studies in collaboration with DSCQ, reporting all serious adverse events in accordance with BI policy
- Communicate effectively both verbally and in writing with investigators, other site staff and members of the Clinical Research and Medical Departments in relation to the conduct and progress of clinical trials and resolution of issues.
- Proactively participate in investigator or team meetings as required
- Generate effective data flow and timely resolution of queries
- Build and enhance relationships with investigators, site staff and key opinion leaders on behalf of the company
- Provide site staff with training and advice on study related issues to support production of high quality documentation
- Resolve site non-compliance and data quality issues (protocol violations, ICH GCP and SOPs) and feedback to Clinical Monitor
- Recommend process improvements and share ideas for enhanced efficiencies with line manager.
- Motivate and support investigators and site staff to achieve target patient recruitment, identifying issues and liaising with site staff and CM to develop solutions.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree in Life Science/ Nursing or Nursing qualification (RGN or equivalent)
- Working knowledge of ICH GCP and clinical trial methodology
- Some knowledge of relevant industry standards and other legislation
- 12 months monitoring experience
- Computer literate
- Good interpersonal and organisational skills.
CK Clinical is an Equal Opportunities employer who 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 CL37240 in all correspondence.
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