Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Clinical Research Associate (CRA) is responsible for the delivery of studies at allocated sites, acting as the main contact with study sites and monitoring study conduct to ensure proper delivery. This role involves site preparation, initiation, monitoring, and closure in compliance with guidelines and regulations. Experienced CRAs may take on additional responsibilities.

Responsibilities

• Contributes to the selection of potential investigators.
• Accountable for study start-up and regulatory maintenance (in some countries).
• Trains, supports, and advises Investigators and site staff on study-related matters.
• Confirms appropriate training completion for site staff.
• Ensures 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.
• Shares information on patient recruitment and study site progress within the LST.
• Drives performance at the sites and resolves study-related issues.
• Updates CTMS and other systems with data from study sites.
• Manages study supplies and drug accountability at study sites.
• Performs monitoring visits (remote and onsite) and remote data checks.
• Determines and discusses the correct timing and type of visits with LSM if required.
• 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.
• Ensures timely data query resolution.
• Works with data management to ensure robust quality of collected study data.
• Ensures accurate and timely reporting of Serious Adverse Events.
• Prepares and finalizes monitoring visit reports in CTMS.
• Follows up on outstanding actions with study sites.
• Follows quality issue processes by escalating systematic or serious quality issues.
• Assists site in maintaining inspection ready ISF.
• Prepares for and collaborates with activities associated with audits and regulatory inspections.
• Ensures timely collection/uploading of essential documents into the eTMF.
• Supports/participates in regular QC checks performed by LSM or delegate.
• 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 and company policies.
• 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.
• 3 years of CRA Experience.
• 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

• 3 years of CRA Experience

Education Level

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

Salary/Compensations

• $112,154.40 - $168,231.60

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

• Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.

Equal Opportunity

• 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.