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  NIH-NIDA Clinical Research

     APPLICATION-PROPOSAL-ABSTRACT-CLINICAL DESIGN-IRB

Grant Writer, Developer & Manager for:

       SUD FACILITY OPTIMIZATION & NEUROSCIENCE INSTITUTE ON ADDICTION

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

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Chief Compliance Officer

GOV, CMS, ASAM, SAMHSA, FEDERAL & STATE  COMPLIANCE 

 

  • Provides Advice, Manages, Coordinates, Recommends, Trains and Supervises the Implementation and Execution of Internal and External Compliance Programs in Concordance with CMS, Joint Commission, Commercial Payers and State Agencies

  • Oversees Staff Competency Training and Supervision Programs for All Licensed and Non Licensed Staff for Local, State and Federal Rules, Regulations and Standards of Compliance

  • Investigates all Internal Staff and Patient Suggestions, Concerns, Complaints and Grievances Acting with an Independent and Objective Framework to: Investigate, Review, Evaluate, and Resolve Incidents with Detailed Reporting

  • Establishes and Maintains Open Lines of Professional Communication and Transparency with All Staff and Leadership to ensure Proper, Effective and Efficient Compliance Standards Through Specific Policies, Procedures and Protocols

  • Develops, Updates and Presents All Internal and External Policies, Procedures and Protocols for Health and Safety, Emergency Management and Contingency Plans with Local, State and Federal Agencies

  • Performs Internal and External Audits for Continuous Monitoring Activities and Formally Documents Detailed Reports for Sustained Continuous Compliance

  • Provides Proper Human Resource Compliance Framework for All Staff and Provider Onboarding Procedures and Due Diligence Credentialing Verifications

  • Creates, Maintains and Reviews Detailed Facility Credentialing Kit for Potential Federal, State or Payer Audits and Contracting Due Diligence Purposes

  • Identifies, Corrects and Documents Any and All Non-Compliance Events and Implements, Executes and Follow Through for all CAP/POC Corrective Action Plans

  • Aggregates, Analyzes, and Records all Compliance Data for Quality Assurance and Performance Improvement Measures

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