Clinical Research Associate role
- 6-month contract
- £150-200 per day
- North West
Do you consider yourself to have effective time-management, the ability to collaborate well with others and regard yourself as an organised individual? If so, then you may be successful in this CRA role working for a highly regarded academic institute. This role is located within the North-West region, on a 6-month contract.
Responsibilities day to day may include:
- Collaborating with other CRAs, the Local Study Team and Local Study Manager to ensure that commitments of the study are achieved efficiently and in a timely manner.
- Monitoring the delivery of the study, making sure everything is conducted in a complicit way.
- Actively participating in Local Study Team (LST) meetings.
- Training, supporting and advising Investigators and site staff in study related matters.
- Updating CTMS and other systems with data from study sites as per required timelines.
- Managing study supplies (ISF, etc), drug supplies and drug accountability at study site.
- Performing Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
- Performing regular Site Quality Risk Assessments, adapting intensity of monitoring as the study progresses.
- Ensuring accurate and timely reporting of Serious Adverse Events and their follow ups.
- Ensures that all study documents are available and ready for final archiving and completion of local part of the eTMF.
Requirements for the role:
- Batchelors degree, preferably within Life Sciences
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Valid driving license
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Familiar with risk-based monitoring approach including remote monitoring.
- Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
If you would like more information on this role or think you would be a great fit, please do not hesitate to get in contact via email to [email protected]