Bhakti Patel Email & Phone Number

Long Beach, CA, US

United States

Responsible for a comprehensive gap analysis of the existing quality management system to ensure adherence to study protocols, study-specific manuals, Glaukos SOPs, GCP guidelines, and applicable regulatory requirements. Developed and implemented a uniform quality management system for medical devices and pharmaceutical products. Responsible for.

Redwood City, California, United States

Responsible for planning, leading, supervising, and the management of the clinical operations and cross-functional team to support the successful movement of multiple projects through the clinical research process in accordance with ICH-GCP, SOPs, and applicable regulatory agencies. Worked with senior management and experts in the field to establish.

Cypress, California

Responsible for providing oversight of study management and financials for regional and global clinical trials from initiation, and execution to closure. Responsible for managing resources (including internal, external, consultants, and vendors) to ensure the timely and cost-effective implementation of the clinical development plan for assigned programs..

United States

Responsible for providing operational oversight and support for the conduct of the assigned clinical trial(s). Responsible for assessing operational feasibility to determine the probability of the study's success. Oversaw the assigned clinical operational staff/team involved in the design and management of the operational activities related to the.

United States

Responsible for the overall execution of the clinical studies, achievement, and deliverables per project plan and customer (sponsor) scope of work. Drives all aspects of the project management process from initiation, planning, execution, control, and closure to ensure that projects are conducted in accordance with GCP and SOP guidelines. Included creating.

United States

Responsible for driving all aspects of the project management processes including but not limited to project initiation, planning, execution, closeout, and risk management/contingency. Coordinated activities and deliverables for all project partners (e.g., internal cross-functional team, external partners, sponsor) and proactively identifies and manages.

Regional- Los Angeles

Project Manager II- Acts as a primary liaison between the Company and the Customer- Ensures the study is progressing according to internal and Customer quality standards, Standard OperatingProcedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH)guidelines to fulfill all federal and local regulations- Serves as.

Cypress, California

• Oversee Marketing, Recruitment (site and international Call Centers), Clinical Trial Conduct (CRCs and CRTs) and Screening Departments
• Highly focus on Phase I healthy volunteers studies including but not limited to bioequivalence, device, cardiovascular, CSF, Flu challenge and ethnobridging.
• Experienced in Phase II to IV studies including but not limited to Oncology, Respiratory, Immunology, Pediatric, Ophthalmology, Infectious disease and Nephrology
• Project Management for all phases of study from startup through study completion of activity
• Analyze study strategies for feasibility of recruitment, enrollment, retention, clinical conduct, resources and timelines
• Participate actively in Site Qualification Visits, Sponsor Audits, FDA Audits, bid defenses, departmental meetings and Internal Audits

Cypress, California

• Managed, restructured and expanded the Clinical Trial Conduct, Clinical Support (RNs, LVNs, MAs, CPT), Scheduling, Lab and Clinical Trial Administrator Departments
• Assessed operational feasibility to determine probability of study success including risk mitigation
• Monitored relationships/processes with sponsors, auditors, CROs, IRBs, laboratories, independent vendors, medical professionals, and investigators
• Provided overall study management with summaries at the end of each project
• Worked closely with Project Managers to ensure that the sponsor’s goals, timelines, cost and quality performance are met in the conduct of all clinical trials
• Facilitated site qualification, Sponsor and FDA Audits, client tours, internal audits, management meetings and quality assuranceAchievements:

Cypress, CA

• Spearheaded processes, regulatory and study related templates
• Assessed relevant training needs for staff, in consultation with CTC managers, including assessment methods and measurement systems entailed to create and implement training courses
• Stayed informed of relevant skills and qualifications levels required by staff for effective performance
• Designed training courses and programs necessary to meet training needs
• Ensured all training activities and materials meet relevant organizational and statutory policies, including health and safety, employment and equality laws

Cypress, CA

• Executed complex clinical research studies including but not limited to medical devices, QT Trials, CSF collections, bronchoscopy and IV infusions
• Spearheaded fellowship program to provide extensive training in clinical research
• Provided mentorship to CRCs and CRTsRest of the duties and responsibilities remain similar to that of the Lead Clinical Research Coordinator's roles

Cypress, CA

• Oversaw regulatory documents to ensure completeness, accuracy, and adherence to protocol, ICH/GCP guidelines, and FDA regulations
• Created and reviewed source documents including study summaries to ensure completeness, accuracy, and adherence to protocol
• Supported the Pharmacy Department by dosing and/or verifying administration of the investigational product to research subjects
• Conducted protocol specific training and maintained the site delegation log up to date
• Observed and directed all significant study days including, but not limited to, admission, PK, and discharge, to ensure all procedures are performed correctly
• Assessed overall study status and quality by maintaining a deviation log and provide deviation reports to Regulatory Coordinator for IRB submission

Cypress, CA

• Performed and completed study procedures
• Assisted Lead and Backup CRCs with study preparations and planning
• Directed study procedures and maintained quality of source documents
• Created lab accounts with local laboratories
• Headed inventory of study supplies

Cypress, CA

• Performed and completed study procedures including but not limited to blood collection, vital signs, ECGs, PFTs, lab processing, dosing/verifying
• Entered subject information into facility database
• Followed all study and non-study regulations including but not limited to HIPAA, OSHA and GCP