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Good Clinical Practice Gcp Jobs in Delaware (NOW HIRING)

IQVIA

CRA 2, Oncology, IQVIA

Wilmington, DE · On-site

$87.20K - $145.30K/yr

... e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to ...

US Tech Solutions

Specialist Study Management

Wilmington, DE · On-site

$33.75 - $45.25/hr

Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and ...

AstraZeneca

Chief Delivery Officer

Wilmington, DE

Deep expertise in GxP-regulated software delivery: hands-on experience with 21 CFR Part 11, EU Annex 11, Computer System Validation (CSV), and Good Clinical Practice (GCP / ICH E6) as they apply to ...

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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.

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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, Sponsor Dedicated

Clinical Research Associate, Sponsor Dedicated

IQVIA

Newark, DE

$71.90K - $189K/yr

Full-time

Posted 28 days ago

IQVIA rating

8.1

Company rating: 8.1 out of 10

Based on 51 frontline employees who took The Breakroom Quiz

55th of 204 rated it services

Job description

To be eligible for this position, you must reside in the same country where the job is located.
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
Bachelor's Degree Degree in scientific discipline or health care preferred.
Requires at least 2 years of year of on-site monitoring experience.
Equivalent combination of education, training and experience may be accepted in lieu of degree.
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Good therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more athttps://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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About IQVIA

Sourced by ZipRecruiter

At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Durham, NC, US

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