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NIH-NIDA Clinical Research APPLICATION-PROPOSAL-ABSTRACT-CLINICAL DESIGN-IRB Grant Writer, Developer & Manager SUD FACILITY OPTIMIZATION, LLC GRANTS & CONTRACTS IDENTITY: 12/12/2000 DUNS #: 117817873 / 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, ERA Commons & 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
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