Clinical Research At AstraZeneca
Key areas of responsibility:
Responsible and accountable for planning, coordinating, overseeing, and conducting local/regional clinical trial
Contributes to the selection of potential investigators.
Contributes to National Investigators meetings.
Develop and implement enrolment strategies, monitoring to adjust for dropouts.
Develop and monitor study budget and timelines and monitor work to ensure quality.
Follow up with CRO on the submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
Trains, supports and advises Investigators and site staff in study related matters
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.
Follow up with the CRO for sites Initiation, monitoring and closure
Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
Ensures data query resolution in a timely manner.
Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
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 or ICH-GCP compliance issues to Local Management
Prepares for and collaborates with the activities associated with audits and regulatory inspections
Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements.
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 AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Ensures compliance with local, national and regional legislation.
Collaborates with local MSLs as directed by line manager.
Minimum Criteria:
Bachelor degree or above, major in pharmacy or health science related background.
Good knowledge of international guidelines ICH-GCP.
4-6 years Pharmaceutical Industry experience in clinical research
Leadership experience in operational management
Excellent command of English (both written and spoken).
Good knowledge of relevant local regulations.
Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
Basic understanding of the drug development process.
Excellent attention to details.
Good written and verbal communication skills.
Good interpersonal skills, a good team player, and computer skills
Be able to prioritize and manage multiple tasks.
Good negotiation skills.
Ability to travel nationally/internationally as required.
Competencies and Personal Attributes:
Previous experience in CRA role.
French language is an addition.
Ability to work in an environment of remote collaborators.
Good analytical and problem-solving skills.
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities