Clinical Research Associate (CRA)
Our client is a world leader in their field.
Purpose of the Job
The opportunity has arisen in this biopharmaceutical company. They are looking for a CRA/ CTM to be predominately office based in their office West of London.
Reporting to Clinical Operations Director with some management of Clinical Trial Associates and Junior CRA's.
Possibly suit someone who has CRO and Pharmaceutical experience.
Main Areas of Responsibility
- Study management (document review and approval/ budget and timeline review/resolve issues on an on-going basis and pro-actively review risk and develop risk mitigation plans) of growing number of studies outsourced to CROs
- Development of a monitoring program, based on a risk-based approach for all active studies to ensure Sponsor oversight compliance
- Develop Monitoring SOPs as required
- Attend site visits with CRO personnel to review processes and develop relationships with investigators
- Form strong and productive relationships with peers and works collaboratively with key cross functional teams within the clients structure
- Champions effective coaching and development of more junior members of the team and helps to support the Clinical Operations Director in retention of high value performers
- Involvement with on-going CRO selection
- Helps and support the Clinical Operations Director in the development of Clinical department working practices and processes as required
- Recent role within a CRO/ Pharmaceutical or Biotech Company
- Direct and recent (within the last two years) on-site monitoring experience
- Detailed knowledge of ICH/GCP, recent updates and adaptive monitoring approaches
- Previous involvement with Investigator Meetings and Site training
- Significant understanding of core teams within the Clinical Trial setting; Regulatory, Safety, Medical writing, Data Management, statistics and IMP management
- Ability to work effectively and independently to fast-moving timelines within a fast-paced working environment
- A flexible and collaborative nature
- Operationally strong and delivery focused
- Ability to travel as required within the UK and outside (current full driving licence and valid passport)
- Fluent in written and spoken English
- Line management
- CRA Team training
- Lead CRA experience on a global study
- Oncology/Respiratory and Gastroenterology Therapy experience
- Global Awareness and cultural sensitivity
- Experience with Electronic Clinical Outcome Assessment (eCOA)
- Degree in a health or scientific discipline or relevant industry experience of 10 years or more
- At least 7 years Clinical Research experience, 5 years of which is specific CRA experience