Consultant and Adviser Resume

SUMMARY

Clinical Research Professional having 16+ years of experience working in Medical Device, Pharmaceuticals and Healthcare Industries.
5+ years of experience with In vitro diagnostics product (IVD).
5+ years of Clinical Monitoring experience.
Experienced with Global Studies, Clinical Site Management, monitored International Sites.
Responsible for negotiating and finalizing clinical trial agreements, contract research organizations (CROs) agreements; prepared and presented project information at internal and external meetings. Managed Sites Clinical Supplies through Vendors and Sponsors both Foreign and Domestic.
Act as Primary contact and Liaison between Study site personnel (PI’s, Coordinators, and Staff) and Clinical Operations (e.g. Sponsor, CRO, Vendors): to maintain the importance of ICH/GCP Guidelines.
Responsible for data mapping and Data Migration. Analyzing and classifying TMF data.
Travel up to 50% - 75% if required

PROFESSIONAL EXPERIENCE

Confidential

Consultant and Adviser

Responsibilities:

Assisting with research techniques: analytical procedures; feasibility procedures; best practice in Pharmaceutical Chain Management; Assist in the planning and managing of project presentation. Area of studies and research: QA/QC, GCP and GLPs Regulations, 21-CFR, IND/ IDE Applications, Diagnostics product, eTMF, Validation and Regulatory Issues, Clinical Trial Protocol, IRB, Clinical Data Quality, Annual Product Review, Validation Master Plan, Summary Reports, Good Documentation Practices, SOPs, Validation Deliverable, FDA Form-483, URS-User Requirement Specification, Continuous Verification of Quality Control processes
Executing site start-up / study start-up activities for assigned protocols with the goal of meeting study timelines.
Ensure the data quality and of deliverables for clinical team through study integrity.
Through continued project maintenance, work to meet site initiation readiness.

Confidential

Sr. CRA

Responsibilities:

Randomized, double-blind, placebo-controlled, parallel-group, study of AB103 as compared to placebo in patients with necrotizing soft tissue infections (NSTI).
Investigative site management and performance, including documentation of in-house and on-site monitoring activities for multiple investigative sites in accordance with designated project assignments (including applicable ICH-GCP and international/national regulatory requirements, and SOPs).
Key secondary endpoints evaluated: Complete and/or partial recovery from AKI (based on Day 28 evaluation); Days in ICU and on ventilator; Time-to-resolution of (Modified Sequential Organ Failure Assessment) mSOFA score to ≤ 1; 30-day hospital readmission rate; 3 month survival and AKI persistence.
Provision of monitoring reports on project status via the development, documentation and implementation of study tracking at the investigative site level.
The management and study-related training of all relevant personnel/positions at investigative sites.
Quality management through reporting of deviations and CAPA as required by SOP, Problem/risk management.
Training, mentoring, and management of Clinical Research Associate(s) as delegated by the Project Manager.