At AstraZeneca (AZ) we are guided in our work by a strong set of values, and we are re-establishing the expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring teams together to deliver exceptional performance. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world as we develop our mission to turn ideas into life-changing medicines that transform lives.

SM&M is a part of Clinical Operations in the Development Operations function and executes and delivers clinical studies (mainly phase II – III) across the UK.

As a Clinical Research Associate (CRA)/Clinical Monitor you will have local responsibility for the delivery of the studies at allocated sites and will be an active participant in the local study team(s). You will work in close collaboration with other Monitors and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will be the main contact with the study site and will have responsibility for proper conduct of the study.

The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations and that the centres deliver according to the commitment in the individual trials.

A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Manager.

Typical Accountabilities

• You will obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the eTMF and Investigator Site File (ISF) in a timeline manner to keep the eTMF “inspection Ready” throughout the study.
• Actively participate in local Study Team meetings.
• Contribute to the selection of potential investigators.
• Train, support and advise Investigators and site staff in study related matters, including Risk Based Quality Management principles.
• Confirms that site staff have completed the required trainings and have documented them appropriately, including GCP training, during the duration of the study.
• You will contribute to national Investigators meetings.
• Initiate monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress within local Study Team.
• Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.
• Update CTMS and other systems with data from study sites as per required timelines.
• You will manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
• Determine and discuss with Local Study Manager the timing of the monitoring visit and whether an on-site or remote visit should be conducted at the site in accordance with the timelines specified in the Monitoring Plan/risk plan.
• Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
• Ensure data query resolution in a timeline manner
• Ensure accurate and timely reporting of Serious Adverse Events.
• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Manager and QA.
• Documents the required monitoring visit reports within required timelines in CTMS.
• Follows-up on outstanding actions with study sites to ensure resolution in a timeline manner.
• Escalates systematic or serious quality, Clinical Study Protocol or GCP compliance issues to Local Management/Local QA. Following monthly quality issue process
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
• Work with data management to ensure quality of the study data.
• Provide feedback to keep track on research intelligence in local markets.
• Ensure compliance with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborate with local MSLs in clinical study support as directed by LSM or line manager

Education, Qualifications, Skills and Experience

• University degree in related discipline, preferably in life science, or equivalent qualification.
• Fluent knowledge of spoken and written English.
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge in 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.
• Ability to travel nationally/internationally as required.
• Valid driving license

Next Steps – Apply today!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.