Managing Partner, project manager and senior consultant for CAP which provides a wide range of services including, but not limited to: one or two person audits, for cause and routine site audits, vendor audits and assessments, data management and database audits, GLP Laboratory audits. GCLP Laboratory audits, Phase I-unit audits and assessments, document audits and QC, trial master file audits and QC, tables listings and figures audits, systems/process audits, Part 11 audits, CSV audits, mock inspections, pre-inspection readiness training, Quality Assurance consultancy via remote and on location support, SOP writing, gap analysis and training across many areas. CAP LLC has experience with both drug and device audits.Therapeutic areas including, but not limited to: Cardiovascular, Gastrointestinal, Pain Management, Diabetes, Infectious Disease, Women's Health, Rheumatology and Inflammatory Diseases, Nutrition, Vaccines, Oncology, Consumer Health Products, Urology, Psychiatry, Dermatology, Neurology, etc. CAP has provided training to Site, Vendor and Sponsor personnel for GCP, Inspection Readiness for FDA and EMA, Part 11 Compliance, Sponsor SOPs and many more areas. CAP can partner with you to provide services for one or multiple audits, training, mock inspection, SOP development, QA Consultancy. We have experience working with small, medium and large pharmaceutical companies.

Responsibilities include:• Management of international and domestic clinical trials.• Performing Monitoring Visits including Site Qualification Visits, Site Initiation Visits, Routine Monitoring Visits and Close Out Visits.• Performing FDA and IRB Submissions.• Feasibility and Study Start-up.• Study Team Management.• Budget and Vendor Management.• Investigator Meeting Preparation, Coordination and Execution.• Provide Quality Support for all CRO functions. • Management of Global Partner CROs.

B&B GxP Consulting can provide one or two person audits. We have performed numerous types of audits and/or assessments of documents, vendors, Phase I units, sites, systems/process across Europe, Australia, North America, South America and Asia. We have GCP, GLP and GMP auditing experience.Audits and Assessments of CROs, Data Management and eDC vendors, Central and Speciality Laboratories, Sites, Documents (ISS, ISE, CO, ICF, CSR, IB, Protocol, Tables, Listings and Graphs, etc.), Biostatics vendors. We have experience writing SOPs in all departments within Pharma (IT, QA, PM, Data Management, Stats, Drug Safety, etc.). We are experienced in site, vendor and Sponsor staff training in many areas. We have performed many Pre-Inspection visits at investigational sites.

Clinical Data Analyst/Data ManagerIMPACT Specialist