India Edwards Email and Phone Number

Preparing regulatory documentation for all study start-up at site, including FDA 1572 forms, financial disclosure forms, SOPs, GCP certifications, calibrations, and IND filings. Tracking and maintaining all medical licenses, CVs, laboratory accreditation for all site staff.Disseminates, tracks, and maintains training records for all involved in clinical trial operations/procedures (scheduling in-service trainings with other required departments); completes all Institutional Review Board (IRB) submissions. Including initial protocol submissions, protocol amendment submissions, continuing review activities, protocol deviations, etc. Posts and maintains regulatory documents/binders including protocols, amendments, consent forms, IB, pharmacy, lab manuals, and sponsor/CRO communication.Assesses potential clinical trial protocol feasibility by reviewing Provider schedules and new patient referrals for potential participants with the CRM and CRC’s as appropriate; ensures all regulatory documentation complies with Institutional Review Board (IRB) policies, procedures, and regulations.Sound understanding of ICH/ GCP guidelines, HIPPA and clinical research regulations, informed consent process, recruitment of research study participants.Working with Research Manager and Study Coordinators to develop and implement efficient Training methods, Standard Operation Procedures, budgets, and patient recruitment strategies.Act as unblinded pharmacist for any double-blind clinical trial activities. Understand and maintain blinded/unblinded components of clinical trials.Train all research staff, mixing techs and infusion nurses on study drug preparation, administration, and disposal. This includes making dosing worksheets, calculating study drug, rate, volume and infusion time, reviewing regimens, potential drug interactions and overall study drug management. Manage studies on multiple platforms such as US Oncology, Shared Investigator Platform (SIP) and DrugDev.

Preparing regulatory documentation for all study start-up at site, including FDA 1572 forms, financial disclosure forms, SOPs, GCP certifications, calibrations, and IND filings. Tracking and maintaining all medical licenses, CVs, laboratory accreditation for all site staff.Disseminates, tracks, and maintains training records for all involved in clinical trial operations/procedures (scheduling in-service trainings with other required departments); completes all Institutional Review Board (IRB) submissions. Including initial protocol submissions, protocol amendment submissions, continuing review activities, protocol deviations, etc. Posts and maintains regulatory documents/binders including protocols, amendments, consent forms, IB, pharmacy, lab manuals, and sponsor/CRO communication.Assesses potential clinical trial protocol feasibility by reviewing Provider schedules and new patient referrals for potential participants with the CRM and CRC’s as appropriate; ensures all regulatory documentation complies with Institutional Review Board (IRB) policies, procedures, and regulations.Sound understanding of ICH/ GCP guidelines, HIPPA and clinical research regulations, informed consent process, recruitment of research study participants.Working with Research Manager and Study Coordinators to develop and implement efficient Training methods, Standard Operation Procedures, budgets, and patient recruitment strategies.Act as unblinded pharmacist for any double-blind clinical trial activities. Understand and maintain blinded/unblinded components of clinical trials.Train all research staff, mixing techs and infusion nurses on study drug preparation, administration, and disposal. This includes making dosing worksheets, calculating study drug, rate, volume and infusion time, reviewing regimens, potential drug interactions and overall study drug management. Manage studies on multiple platforms such as US Oncology, Shared Investigator Platform (SIP) and DrugDev.