UNKNOWN

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Additional responsibilities include consenting, conducting subject visits, specimen collection/processing/shipping, IP management, data entry, query resolution, participant payment processing, research billing review, subject and study documentation, assessing logistics for study implementation, ensuring compliance with study protocols and regulatory requirements, and supporting data analysis. As the Gastroenterology (GI) Clinical Research Nurse Coordinator (CRNC) you will support the divisional research portfolio by utilizing clinical nursing assessment skills to plan, provide, supervise, and document professional nursing care utilizing the nursing process for research participants in accordance with physician orders, study protocols, and established policies and procedures.

YEAR

Duke University

Clinical Research Nurse Coordinator

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You'll join a fast-paced, growth-oriented environment where you can continue impacting patient access to innovative therapies, apply regulatory knowledge across multiple therapeutic areas, influence drug development strategies earlier in the product lifecycle, and serve as a trusted advisor to industry leaders. If you have built your career at the FDA as a Clinical Pharmacology Reviewer, Master Reviewer, Team Lead, or other senior role as a subject matter expert in Clinical Pharmacology, this role offers a unique opportunity to leverage your regulatory expertise across a diverse portfolio of innovative development programs.

The expertise and passion for excellence shared by our people around the world unites us in our mission and drives our success. As a premier service provider to the global biopharmaceutical industry, we give you the opportunity to work with industry-leading clients in an exciting, collaborative environment where career choices and development paths are abundant, and projects are challenging. In fact, PAREXEL works with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. With over 30 years of experience, we have supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. We offer our employees the ability to make a difference globally, while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential. Discover a career at PAREXEL, where exciting challenges and opportunities await you.

Parexel International Corp

Vice President, Regulatory Science - Clinical Pharmacology SME

Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. You will be responsible for all day to day study activities (such as subject consent and enrollment, data collection and entry, participant compensation, study monitoring activities, etc.), and will work with the lead coordinator to manage regulatory tasks (such as study start up and close out, IRB tasks, etc.).

Clinical Research Coordinator

Participates in or leads day-to-day clinical research data operations conducted by Principal Investigator(s) within the Leukemia Clinical Research Team (CRT) as part of the Hematologic Malignancies and Cellular Therapies (HMCT) research groups within Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (CRU); performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center.

Clinical Data Manager

Processes incoming requests, collection of information needed for review from providers, utilizing scripts to screen basic and complex requests for precertification and/or prior authorization, and reviews supporting documentation (clinical notes/labs when applicable) to meet payer-specific criteria. Responds to telephone and written inquiries from clients, providers and in-house departments; communicates authorization status updates to providers/clinical staff, and supports denial follow-up by coordinating additional medical necessity information when needed.

Clinical Reviewer Jobs in Morrisville, NC

Clinical Research Nurse Coordinator Duke University

Vice President, Regulatory Science - Clinical Pharmacology SME Parexel International Corp

Clinical Research Coordinator Duke University

Clinical Data Manager Duke University

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