Nisha Patel Email and Phone Number

• Provides mentorship to new and incoming CRA • Manages multiple projects efficiently while meeting deadlines • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines. • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites. • Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely. • Provides regular site status information to team members, trial management, and updates trial management tools. • Completes monitoring activity documents as required or other contractual obligations. • Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues. • Escalates site and trial related issues until identified issues are resolved or closed. • Performs essential document site file reconciliation. • Performs source document verification and query resolution. • Assesses IP accountability, dispensation, and compliance at the investigative sites. • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines. • Communicates with investigative sites Updates applicable tracking systems • Ensures all required training is completed and documented. • Facilitates audits and audit resolution. • Trains site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion. • Oversees IP dispensing, inventory and reconciliation documents. • Conducts regular site visits, coordinating project meetings and writing visit reports. • Implements action plans for sites not meeting study expectations.

• Hematology and Oncology study coordinator ●Leukemia/Lymphoma study coordinator● Study start-up/close out● Responsible for all regulatory aspects of studies of Phase I/II studies● Conduct screening and enrollment for multiple oncology studies● Report and track all related Serious Adverse Events● Participating in multiple study audits● Work with multiple teams of the hospital for movement and shipping of laboratory samples● Participating in improvement of clinic flow● Training of other CRCs● Data entry into multiple EDC platforms

• Review Informed Consent• Review protocol • Maintain and complete regulatory documents• Conduct screening visits for multiple studies• Collect medical history, concomitant medications, vitals• Review eligibility criteria • Enroll patients into clinical trials• Attend Investigator meetings and start-ups• Coordinate movement of laboratory samples • Keep track of drug supplies• Track and report Adverse events, Serious adverse events and deviations • Assist with sponsor and FDA audits• Involved in recruitment strategies • Data entry into various EDC platforms • Teaching subjects about protocol expectations • Performing study/protocol procedures in a detailed, accurate manner• Following ICH-GCP• Following SOP's• Phlebotomy• Perform EKGs

● Asses hospital/clinical referrals● Coordinate patient admission and discharge● Tour incoming patients of facility● Organize admissions with referrals through Allscripts● Check and verify insurance, Medicare and Medicaid ● Perform managerial duties when needed● Process monthly referrals with marketing team● Speak and consult healthcare professionals daily