Clinical Research Associate

Clinical Research Associate

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

You will be responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with internal Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

The CRA will usually have these accountabilities:

• Contributes to the selection of potential investigators.
• Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
• Proves that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
• Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the local study teams.
• Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues.
• Updates CTMS and other systems with data from study sites as per required timelines.
• Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
• Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with Local Study Manager (LSM) the correct timing and type of visits.
• 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.
• Ensures data query resolution in a timely manner.
• Works with data management to ensure robust quality of the collected study data.
• Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
• Prepares and finalises monitoring visit reports in CTMS and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.
• Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
• Follows quality issue processes by raising systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
• Assists site in maintaining inspection ready ISF.
• Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
• Ensures timely collection/uploading of crucial documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSM or delegate.
• Ensures that all study documents under their responsibility (i.e. site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF.
• Ensures compliance with local, national and regional legislation, as applicable.

You should have the following qualifications and skills:

• Minimum 24 months experience on CRA position - is a must
• Bachelors degree in related subject area, preferably in life science, or equivalent qualification.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of local regulations.
• 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.
• Excellent attention to details.
• Good written and verbal communication skills.
• Good teamwork and interpersonal skills.
• Ability to travel nationally/internationally as the need arises.