The (Senior) Clinical Research Associate (S/CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The (S)CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The (S)CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

The (S)CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ 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.

A (S)CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.

(S)CRA is expected that after onboarding period and  handover process, to actively take over the project and site related responsibilities (independent monitoring). CRAs might have different internal titles based on the experience level (CRA, Senior CRA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head).

Responsibilities:

Contributes to the selection of potential investigators.

In some countries, as required, (S)CRA s are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.

(S)CRA may serve as a mentor  for less experienced  CRAs and act as a role model for junior CRAs

Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.

Confirms 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.

Actively participates in Local Study Team (LST) meetings.

Contributes to National Investigators meetings, as applicable.

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 LST.

Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.

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 LSAD 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 escalating 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 LSAD and CQAD.

Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD 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.

Requirements:

Essential

Excellent knowledge of Polish and English in writing and speaking

Bachelor degree in related discipline, preferably in life science, or equivalent qualification.

Prior experience in CRA role – at least 2 years of independent project monitoring is a must. (S)CRA must have at least 3 years of experience in independent project monitoring.

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.

Good knowledge of relevant 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.

Excellent written and verbal communication skills.

Ability to seamlessly collaborate within a team.

Good negotiation skills.

Ability to travel nationally/internationally as required.

Valid driving license

Preferred location – central Poland

Desirable expertise in metabolic/diabetes/immunology TA.

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.