Precision Neuropeptide Infusion

  NIH-NIDA Clinical Research

     APPLICATION-PROPOSAL-ABSTRACT-CLINICAL DESIGN-IRB

       NEUROSCIENCE INSTITUTE ON ADDICTION RECOVERY

NPIs: 1467193623 & 1083355119

GOVERNMENT GRANTS & CONTRACTS IDENTITY: 12/12/2000- 12/12/2025

       DUNS #: 014328223  /  SAM #: JAC6JJKYAF77  /  CAGE CODE #: 8TT10

• Directing and implementing Clinical research plans and programs according to established design principles. Directing the integration of the CDP and DDP 

• Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds

• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and

• Leading the development of Clinical Protocols to meet CDP objectives

•  Planning clinical trials (design, operational plans, settings) based on these clinical development strategies

• Developing of clinical development strategies for investigational or marketed products or drugs

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications

• Acts as a cross-functional liaison to ensure study plan aligns with business development strategies. 

• Oversees the conduct of clinical trials in compliance with the International Council for Harmonization (ICH), Good Clinical Practices (GCP’s) and applicable regulatory requirements. 

• Participates in the assessment and selection of vendors and Contract Research Organizations (CRO’s), Clinical investigators and investigative sites. 

• Develops, reviews, approves, and maintains primary and supplemental study plans, reports, procedures, and documents per established SOPs. 

• Reviews metrics, trends, and other reporting tools on an ongoing basis to ensure proper conduct of the vendors contracted tasks and to reconcile clinical budget. 

• Directs monitoring activities to ensure reported trial data are accurate, complete and verifiable in accordance with study plans. 

• Provides project knowledge, guidance and training to the clinical sites and study team to promote protocol adherence. 

• Facilitates project meetings and the communication of project information internally and externally in order to maintain timelines and assure events are achieved. 

• Works closely with Quality Assurance to develop audit plans, participate in audits as needed, and assist with the review and close out of audit reports. 

• Performs other tasks and projects as assigned. 

• Represents the company with a high level of integrity and professionalism. 

• Adheres to company’s policies and supports management decisions and goals in a positive, professional manner.

• Application Process and Set up: 3 Months, 4 Steps and Full Company Vetting Process with: Dunn & Bradstreet, SAM, CAGE, ERACommons & Login.gov

• Application Process and the Creation of Passable Documents and Materials for Scientific Merit and IRB

• RFA Search and Eligibility Criteria Must be Review before applying in ERA Assist