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Good Clinical Practice Gcp Jobs in Delaware (NOW HIRING)

AstraZeneca

Study Start Up Manager

Wilmington, DE · On-site

... with ICH-GCP, AZ Procedural Documents. - Assist in coordination and administration of clinical ... experience - Good knowledge of international guidelines ICH-GCP as well as relevant local ...

AstraZeneca

Study Start Up Manager

Wilmington, DE · Hybrid

... with ICH-GCP, AZ Procedural Documents. - Assist in coordination and administration of clinical ... experience - Good knowledge of international guidelines ICH-GCP as well as relevant local ...

AstraZeneca

Study Start Up Manager

Wilmington, DE · On-site

... with ICH-GCP, AZ Procedural Documents. - Assist in coordination and administration of clinical ... experience - Good knowledge of international guidelines ICH-GCP as well as relevant local ...

AstraZeneca

Study Start Up Manager

Wilmington, DE · Hybrid

... with ICH-GCP, AZ Procedural Documents. - Assist in coordination and administration of clinical ... experience - Good knowledge of international guidelines ICH-GCP as well as relevant local ...

QPS, LLC

Lab Training Specialist

Newark, DE · On-site

$50K - $56K/yr

These functions are guided by the principles of Good Clinical Practices (GCPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs) (21 CFR Parts 11, 50, 56, 58) as well as ...

QPS, LLC

Lab Training Specialist

Newark, DE · On-site

$50K - $56K/yr

These functions are guided by the principles of Good Clinical Practices (GCPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs) (21 CFR Parts 11, 50, 56, 58) as well as ...

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Good Clinical Practice Gcp information

What are the key skills and qualifications needed to thrive as a Good Clinical Practice (GCP) professional, and why are they important?

To thrive as a Good Clinical Practice (GCP) professional, you need a deep understanding of clinical research protocols, regulatory guidelines, and ethical standards, often supported by a background in life sciences or healthcare. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) tools, and GCP certification is typically required. Attention to detail, strong organizational skills, and effective communication are vital soft skills for ensuring compliance and collaboration across research teams. These competencies are crucial to safeguarding patient safety, maintaining data integrity, and ensuring successful regulatory audits in clinical research.

What are some common challenges faced by professionals working in Good Clinical Practice (GCP) compliance roles?

Professionals in GCP compliance roles often encounter challenges such as staying updated with evolving regulatory requirements, ensuring consistent documentation standards across multiple clinical sites, and balancing strict adherence to protocols with the practical needs of clinical teams. They also need to collaborate closely with investigators, sponsors, and regulatory authorities to address discrepancies and maintain data integrity. Effective communication and problem-solving skills are essential for facilitating audits and managing any non-compliance issues that arise during clinical trials.

What are Good Clinical Practice (GCP) guidelines?

Good Clinical Practice (GCP) guidelines are a set of internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. They ensure that the rights, safety, and well-being of trial participants are protected and that clinical trial data are credible and accurate. GCP applies to all aspects of clinical research and is required by regulatory authorities worldwide to ensure ethical conduct and data integrity.

What is the difference between Good Clinical Practice Gcp vs Clinical Research Coordinator?

AspectGood Clinical Practice GcpClinical Research Coordinator
CertificationsGCP training, regulatory knowledgeOften GCP training, site-specific protocols
Work EnvironmentRegulatory compliance, monitoring, auditsManaging trial activities at research sites
Employer & IndustryPharmaceutical companies, CROs, regulatory agenciesHospitals, clinics, research sites

GCP professionals focus on ensuring clinical trials meet regulatory standards, while Clinical Research Coordinators manage day-to-day trial activities at research sites. Both roles require GCP knowledge but differ in scope and responsibilities.

What are popular job titles related to Good Clinical Practice Gcp jobs in Delaware? For Good Clinical Practice Gcp jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Good Clinical Practice Gcp jobs in Delaware look for? The top searched job categories for Good Clinical Practice Gcp jobs in Delaware are:
What cities in Delaware are hiring for Good Clinical Practice Gcp jobs? Cities in Delaware with the most Good Clinical Practice Gcp job openings:
Good Clinical Practice Gcp jobs near you
Clinical Research Associate - Cell Therapy

Clinical Research Associate - Cell Therapy

AstraZeneca

Wilmington, DE • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 14 days ago

AstraZeneca rating

8.6

Company rating: 8.6 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

16th of 70 rated pharmaceutical

Job description

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 based in California.
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.
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!
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.
Date Posted
14-May-2026
Closing Date
28-May-2026
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.

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