AstraZeneca Pharmaceuticals LP Senior CRA in Spain
At AstraZeneca every one of our employees makes a difference to patient lives everyday.
Each and every one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.
The CRA/Clinical monitor has local responsibility for the delivery of the studies at allocated sites and are active participants in the local study team(s). The Monitor works in close collaboration with other Monitors and the Local Study Team/ Local Study Manager to ensure that quality and quantity commitments are achieved in a timely and efficient manner. The Clinical Monitor acts as the main contact with the study site and has the 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. As Local Study Manager the person will have the overall responsibility for the study commitments within the country, for timely delivery of data to required quality.
Main Duties and Responsibilities
· Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the eTMF and 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 RbQM principles.
· Confirms that site staff have completed the required trainings and have documented them appropriately, including GCP training, during the duration of the study.
· 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.
· 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 LSM 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, CSP 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.
Comply with all external regulations and internal policies
Ensure compliance with AZ Policies and Standards with special emphasis on Code of Conduct, Ethical Interaction Policy and Standards, Privacy (Patient Group interactions) and Procurement (engagement of third-parties)
· Minimum University degree preferably in biological science or healthcare-related field.
· Minimum 4 years experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies).
· Excellent knowledge of spoken and written English.
· Recent experience as CRA/clinical monitor of at least 4 years.
· Good ability to learn and to adapt to work with IT systems.
· Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with maintained quality.
· Good knowledge of international guidelines - ICH/GCP as well as relevant local regulations.
· Good medical knowledge in relevant AZ Therapeutic Areas.
· Good understanding of the Drug Development and Handling Process.
· Good knowledge in Clinical Operations.
· Excellent understanding of the Clinical Study Process including monitoring and local data management handling.
· Good resource and finance management skills.
· Good decision and delegation skills.
· Basic change management skills.
· Basic coaching skills.
· Basic ability in handling crisis situations.
· Excellent project management skills.
· Excellent team building and interpersonal skilsl.
· Good intercultural awareness.
· Excellent organisational skills.
· Good analytical skills.
· Good negotiation skills.
· Excellent communication skills, verbal and written.
· Excellent ability to prioritize and handle multiple tasks.
· Excellent ability to have attention to details.
· Good ability in working according to global standards.
· Ability to travel nationally and occasional international travel.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.