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About the Role

The Clinical Research Associate (CRA) is responsible for the delivery of studies at allocated sites, acting as the main contact with the study site and monitoring study conduct to ensure proper delivery. The CRA prepares, initiates, monitors, and closes assigned sites in compliance with guidelines and regulations, ensuring sites meet their commitments.

Responsibilities

• Contributes to the selection of potential investigators.
• Performs Site Qualification Visits.
• Collects, prepares, reviews, and tracks documents for the application process.
• Submits applications/documents to EC/IRB and Regulatory Authorities.
• Trains, supports, and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms site staff have completed required trainings, including ICH-GCP.
• Ensures sites are inspection ready at all times.
• Actively participates in Local Study Team (LST) meetings.
• Contributes to National Investigators meetings.
• Initiates, monitors, and closes study sites in compliance with AZ Procedural Documents.
• Shares information on patient recruitment and study site progress 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.
• Manages study supplies, drug supplies, and drug accountability at study sites.
• Prepares study drug for destruction, if applicable.
• Performs monitoring visits (remote and onsite) and remote data checks.
• Determines and discusses with LSM the correct timing and type of visits.
• 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.
• Ensures data query resolution in a timely manner.
• Works with data management to ensure robust quality of 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.
• Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues.
• Assists site in maintaining inspection ready ISF.
• Prepares for and collaborates with audits and regulatory inspections.
• Ensures timely collection/uploading of essential documents into the eTMF.
• Supports/participates in regular QC checks.
• Ensures all study documents are available and ready for final archiving.
• Provides feedback on research-related information useful for the local market.
• Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures.
• Ensures compliance with local, national, and regional legislation.
• Collaborates with local MSLs as directed by LSM or line manager.

Requirements

• Bachelors degree in a 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.
• 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.

Skills

• ICH-GCP
• GMP/GDP
• Risk Based Quality Management (RbQM)
• Clinical Study Management
• Monitoring
• Study drug handling
• Data management
• Attention to details
• Written communication
• Verbal communication
• Collaboration
• Interpersonal skills
• Negotiation skills
• Travel
• Driving

Location

• New York
• New Jersey

Work Type

• Onsite
• Remote

Experience Level

• CRA with longer tenure and experience may take on additional responsibilities

Education Level

• Bachelors degree in related discipline, preferably in life science, or equivalent qualification

Salary/Compensations

• $112,154.40 - $168,231.60
• Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)
• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

• AstraZeneca is a global, science-led, patient-focused biopharmaceutical company.
• We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases.
• At AstraZeneca, we’re dedicated to being a Great Place to Work.
• Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.
• To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
• There is no better place to make a difference in medicine, patients, and society.
• An inclusive culture where you will connect different thinking to generate new and valuable opportunities.
• Where you will find a commitment to lifelong learning, growth and development for all.
• Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients.
• Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.
• We’re curious about science and the advancement of knowledge.
• We find creative ways to approach new challenges.
• We’re driven to make the right choices and be accountable for our actions.
• As an organisation centred around what makes us human, we put a big focus on people.
• Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab.
• Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.
• Here, you’ll do work that has the potential to change your life and improve countless others.
• And, together with your team, you’ll shape a culture that unites and inspires us every day.
• This is your life at AstraZeneca.

Equal Opportunity

• 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.