Clinical Research Associate, Cell Therapy - Mid Atlantic

AstraZeneca plc; New York (NY); Presencial; USD 112.000 - 168.000; Tempo integral

Resumo da vaga

AstraZeneca plc seeks a Clinical Research Associate to oversee delivery of studies at allocated sites and act as the primary contact for study sites. This field-based role favors candidates residing in the Mid-Atlantic region, with travel nationally and internationally as required.

You will initiate, monitor, and close sites in accordance with ICH-GCP and AstraZeneca SOPs, maintain CTMS/ISF, and train site staff. Collaboration with LSAD, QA, and MSLs is essential for study success.

Qualificações

• Bachelor's degree in Life Sciences or related field.
• Minimum 3 years CRA or similar experience in pharma/ CRO.
• Excellent knowledge of ICH-GCP; basic GMP/GDP knowledge.
• Strong site monitoring, data management, and documentation skills.
• Willingness to travel nationally and internationally.

Responsabilidades

• Contributes to investigator selection.
• Supports start-up and regulatory maintenance activities (SQVs, regulatory documents, EC/IRB submissions).
• Trains and advises investigators and site staff on trial matters (RbQM).
• Ensures training completion and inspection readiness of sites.
• Performs onsite and remote monitoring per Monitoring Plans.
• Maintains CTMS/ISF and drug accountability; conducts SDR/SDV/CRF review.
• Prepares monitoring visit reports and follow-up letters on time.
• Escalates quality issues to Local Management and QA teams.

Conhecimentos

ICH-GCP knowledge

Regulatory knowledge

Study monitoring

Site management

Communication skills

Attention to detail

Travel readiness

Formação

Bachelor's degree in Life Sciences

Ferramentas

CTMS

eTMF familiarity

Descrição da vaga

The Clinical Research Associate (CRA) has local responsibility for the delivery of 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 primary contact with study sites and is responsible for monitoring study conduct to ensure proper delivery of clinical trials. This is a field-based position with a strong preference for candidates residing within the Mid-Atlantic region, including Maryland, Virginia, Washington D.C., Delaware, Pennsylvania, and New Jersey. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies in compliance with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations, ensuring that sites deliver according to study commitments. A CRA with longer tenure and experience may take on additional responsibilities, including tasks associated with the Local Study Associate Director (LSAD) role.

Typical Accountabilities

• Contributes to the selection of potential investigators.
• Supports study start-up and regulatory maintenance activities, including Site Qualification Visits (SQVs), collection and review of regulatory documents, and submission activities to EC/IRB and Regulatory Authorities as applicable.
• Trains, supports, and advises investigators and site staff on study-related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms site staff have completed required training, including ICH-GCP training, prior to and throughout the study duration. Ensures sites remain inspection ready at all times.
• Actively participates in Local Study Team (LST) meetings.
• Contributes to Investigator Meetings as applicable.
• Initiates, monitors, and closes study sites in compliance with AstraZeneca Procedural Documents. Shares updates on patient recruitment and site performance within the LST.
• Drives site performance by proactively identifying, resolving, and escalating study-related issues as appropriate.
• Updates CTMS and other clinical systems within required timelines.
• Manages study supplies, ISF documentation, investigational product accountability, and study drug reconciliation/destruction activities where applicable.
• Performs onsite and remote monitoring visits, including remote data review activities, in accordance with study-specific Monitoring Plans.
• Performs Source Data Review (SDR), Source Data Verification (SDV), and CRF review activities.
• Conducts Site Quality Risk Assessments and adjusts monitoring intensity accordingly throughout the study.
• Ensures timely resolution of data queries and collaborates with Data Management to maintain high-quality study data.
• Ensures accurate and timely reporting of Serious Adverse Events (SAEs) and follow-up documentation.
• Prepares and finalizes monitoring visit reports and follow-up letters within required timelines and in accordance with AstraZeneca SOPs.
• Follows up on outstanding site actions to ensure timely resolution.
• Escalates significant quality issues, compliance concerns, data privacy breaches, or ICH-GCP deviations to Local Management and/or Quality teams as required.
• Assists sites in maintaining inspection-ready Investigator Site Files (ISF).
• Supports audit and regulatory inspection readiness activities in collaboration with LSAD and Quality teams.
• Ensures timely collection and upload of essential documents into the eTMF in compliance with ICH-GCP, AstraZeneca SOPs, and local requirements.
• Ensures study documentation is complete and ready for final archiving activities.
• Provides insights regarding investigators, sites, and competing studies relevant to the local market.
• Ensures compliance with AstraZeneca's Code of Ethics and company policies related to Safety, Health & Environment (SHE), security, technology, finance, and people practices.
• Ensures compliance with local, national, and regional regulations as applicable.
• Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line management.

Minimum Qualifications

• Bachelor's degree in Life Sciences or related discipline, or equivalent qualification.
• Minimum 3 years of CRA or similar relevant clinical research experience within the pharmaceutical, biotechnology, or CRO industry.
• Excellent knowledge of ICH-GCP guidelines and basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations and clinical trial requirements.
• Strong medical and scientific aptitude with the ability to learn AstraZeneca therapeutic areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management, including site monitoring, study drug handling, and data management.
• Strong attention to detail and documentation accuracy.
• Excellent written and verbal communication skills.
• Strong collaboration, interpersonal, and relationship-building skills.
• Good negotiation and conflict-resolution skills.
• Ability to travel nationally and internationally as required.

Desirable Qualifications

• Clinical trial or relevant experience in Cell Therapy preferred. Ability to work effectively in an environment with remote collaborators and cross-functional teams.
• Positive and adaptable approach to change management.
• Ability to identify and champion process improvements that increase efficiency and quality.
• Strong analytical and problem-solving capabilities.
• Ability to prioritize and manage multiple competing deadlines effectively.
• Familiarity with risk-based monitoring methodologies, including remote monitoring.
• Good cultural awareness and ability to work within global teams.
• Proficiency with clinical systems, software platforms, and technology-enabled environments.
• Team-oriented, flexible, and responsive to shifting priorities and business needs.

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

The annual base pay for this position ranges from $112,154.40 - $168,231.60. 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. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Our mission

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.