[Hiring] Clinical Research Associate @AstraZeneca

Role Description

The Clinical Research Associate (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 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 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 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.

• Contributes to the selection of potential investigators.
• Accountable for study start-up and regulatory maintenance, including:
  • 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
• 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.
• 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.
• Drives performance at the sites and proactively identifies and resolves 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.
• Performs monitoring visits (remote and onsite) in accordance with the timelines specified in the study specific Monitoring Plan.
• Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV).
• 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 finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator.
• 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 as required.
• Assists site in maintaining inspection ready ISF.
• Prepares for and collaborates with the activities associated with audits and regulatory inspections.
• Ensures timely collection/uploading of essential documents into the eTMF.
• Ensures that all study documents under their responsibility are available and ready for final archiving.
• Provides feedback on any research related information that might be useful for the local market.
• Ensures compliance with AstraZeneca’s Code of Ethics and company policies.
• Ensures compliance with local, national and regional legislation, as applicable.
• Collaborates with local MSLs as directed by LSAD or line manager.

Qualifications

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• 3+ years experience as a CRA.
• 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.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Ability to travel nationally/internationally as required.
• Valid driving license.

Requirements

• The annual base pay for this position ranges from $112,154.40 - $168,231.60 USD.
• Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.
• Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
• Short-term incentive bonus opportunity; eligibility to participate in equity-based long-term incentive program (salaried roles).
• Retirement contribution (hourly roles) and commission payment eligibility (sales roles).

Benefits

• Qualified retirement program [401(k) plan].
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.

Company Description

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.