Imanova is recruiting for a Senior Study Coordinator, to provide support with all clinical activities necessary to the conduct of Imaging / Experimental Medicine Studies.
A partnership between the Medical Research Council, Imperial College London, King's College London and University College London, Imanova provides a world class medical imaging service to industry and academic clients combining Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) imaging modalities. Imanova is involved in the development and manufacture of radioisotopes and injection into patients/volunteers as part of clinical programmes.
Imanova are currently seeking a Senior Study Coordinator to assist the Principal Study Co-ordinator with all clinical support activities necessary to the conduct of Imaging/Experimental Medicine Studies in accordance with current Regulatory, ICH GCP, GLP, HBSM and GMP standards and requirements
The candidate will be responsible for the following:
- Timely completion, within budget, of the clinical operationalization of Imanova assigned studies according to Imanova standards and ICH GCP, ensuring regulatory requirements for registration are met.
- Ensuring the safety of studies in Imanova at all times.
- Ensuring all administrative and operational arrangements across studies are managed effectively to enable studies to proceed in an optimal manner.
- Preparing study medication in accordance with GMP.
- Supervision and delivery of training for all clinical support staff including professional development, use of equipment, regulatory guidelines, processes and procedures, legal and ethical standards and maintaining own training in all technical activities undertaken in studies.
- Keeping up to date with scientific and medical knowledge of all compounds under current investigation within Imanova, understanding the likely pharmacological profiles and assessing the significance of reported adverse events.
- Reporting any deviation from SOP, protocol or GCP and all issues related to the study conduct to the Principal Study Co-ordinator.
- Maintaining proficiency in Intermediate Life Support and use of emergency equipment.
The candidate must be able to demonstrate:
- Minimum of 4 years nursing experience. Minimum of 2-3 years of clinical research experience, preferably industry based.
- Psychiatric experience would be an advantage.
- Skill and experience in clinical study management.
- Understanding of the drug development process.
- Computer literacy with a thorough understanding of the utilization of EDC software for data collection and management.
- An ability to organise and prioritise, and to handle a complexity of responsibilities, delegating as appropriate.
Candidates must have excellent verbal and written communication skills, analytical skills, a logical approach to problem solving and an attention to detail.
Competitive Salary & Benefits: Bonus, Contributory Pension, Private Medical Insurance, Life Assurance & Flexible Benefits options.
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