AstraZeneca Pharmaceuticals LP Clinical Research Associate in Uccle, Belgium
High-level summary of the position with main purpose of the position and how it will be successfully accomplished:
The Clinical Research Associate (CRA) has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study team(s) in NLBE. The CRA works in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.
The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies per AstraZeneca Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Senior CRA or Local Study Team Leader (LSTL).
Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)
Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site. Ensure completeness of the Trial Master File.
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.
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.
Utilize Risk Based Monitoring approach including remote monitoring.
Drive performance at the sites. Proactively identify study-related issues and ensure query resolution.
Update IMPACT and other systems with data from centers as per required timelines.
Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
Perform source data verification and source data review per SDV plan.
Ensure accurate and timely reporting of Serious Adverse Events.
Prepare for activities associated with audits and regulatory inspections in liaison with LSTL and CPrM.
Provide the required monitoring visit reports within required timelines (remote or on site visits).
Work with sites and data management to ensure quality of the study data and early data entry.
Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Cooperate with Medical Science Liaisons in their support of the designated clinical studies.
Leadership and Functional Capabilities:
Exemplify the AstraZeneca Values and behaviours (see annexe)
Ability to deliver quality per the requested standards.
Ability to work in an environment of remote collaborators and manager.
Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
Good analytical and problem solving skills.
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
Good cultural awareness.
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
Education, Qualifications and Experience
University degree in related discipline, preferably in life science, or equivalent qualification.
Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
Good knowledge of relevant local regulations with main focus on Belgium.
Good medical knowledge in relevant AZ Therapeutic Areas.
Good understanding of the drug development process.
Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
Ability to travel nationally (Belgium and Netherlands) and internationally as required.
Valid driving license
Languages: fluent Flemish/Dutch, French, English
- Knowledge on relevant regulations in Netherlands