Clinical Scientist

• 2022 - Present

Clinical Trials Manager

• 2022 - 2022

Medical Device Specialist

• 2021 - 2022

Reviewed adverse events having to do with medical device defects. Performed demonstrations on various medical devices. Provided advice to contribute to product development, updates, or other improvements. Instructed hospital staff on the correct implementation of medical devices. Gathered customer experience data using eCOA’s. Reviewed adverse events having to do with medical device defects. Performed demonstrations on various medical devices. Provided advice to contribute to product development, updates, or other improvements. Instructed hospital staff on the correct implementation of medical devices. Gathered customer experience data using eCOA’s.

Health Project Coordinator

• 2020 - 2021

Act as interface between clinical trials investigators, physicians, nursing staff, clinical research subjects (and family members), study monitors, contracted support services, and clinical sponsors for gastrointestinal oncology clinical trials involving human subjects Attend to administrative needs related to clinical trials, including matters involving data management, regulatory, and finance issues. Also participate in in-service training opportunities as required. Address queries from internal and external parties; facilitate onsite monitoring visits Review study protocols, attend investigator conferences and teleconferences as needed. Collaborate with Cancer Institute team members to develop operational plans and procedures for clinical trials Review eligibility requirements for potential study subjects; perform clinical support duties as needed, for implementation and operation of clinical trials at the Cancer Institute Show less

Clinical Trials Coordinator

• 2020 - 2020

Administratively and clinically manage clinical trials, including scheduling all patient research visits and procedures. Adhere to research SOP's, Good Clinical Practice, and study protocols. Ensure scientific integrity of data and protected rights, safety, and well-being of patients enrolled in trials. Discuss study protocols with patients, verified information consent documentation, and maintained accessibility to discuss questions or concerns regarding the study. Dispense study medications, perform ECG's, screen lab results, as well as collect, process, and ship blood/urine specimens at scheduled patient visits. Complete and maintain case report forms per FDA guidelines, ensuring serious and non-serious adverse events are properly documented and reported. Show less

Sub Investigator of Clinical Trials

• 2019 - 2019

Involved with recruiting, screening, consenting, treatment, and monitoring of patients during clinical trials, including safety and adverse events reporting. Reviewed source documentation to ensure subject eligibility to protocol inclusion/exclusion requirements. Carried out physical and neurological exams, EKG's, phlebotomy, and lab work evaluation of patients involved with clinical trials. Administered study drugs per protocol (including placing and monitoring IV infusions). Maintained IP logs. Packed and shipped investigational product. Ensured study protocols and procedures adhered to ICH-GCP guidelines and met FDA regulations for the care of study participants. Entered patient information into the EDC (Medidate Rave) Show less

Medical Data Reviewer

• 2016 - 2019

Conducted clinical trial data review (evaluation, organization, and verification) in accordance with study protocol, standard operating procedures (SOPs), GCP, and all applicable regulatory requirements. Reviewed patient data to determine acceptance in a clinical trial, identifying anomalies requiring further investigation to determine overall accuracy. Maintained medical records, ensuring investigational product dosing adhered to protocol and identified possible inaccuracies or missed doses. Reviewed documentation, verified that end of treatment and end of study information was accurate and all supporting documents were in sync. Analyzed laboratory results, ensuring completeness of information and adherence to protocol schedules, collaborated with other medical staff to verify information. Performed data analytics by reviewing visuals and identified potential issues pertinent to each study. Met quality targets based on independent review and employee level results, maintained error rate of less than prescribed amount; met all TAT, project deliverables, and milestones for all projects. Successfully applied accurate time coding and internal process compliance within systems. Show less

Chief Medical Officer

• 2013 - 2016

Chief Medical Officer (2014 to 2016) Resident Doctor (2013 to 2014)  In consecutive roles, provided medical care, conducted clinical rounds, monitored wards, and served as physician on call in the ICU and ER.  Performed health assessments, in charge of various medial camps, ran diagnostic tests, created treatment plans, and provided health and wellness advice to patients.  Treated inpatients and outpatients, across all medical and surgical fields.  Completed extensive work in Forensic Medicine (forensic evidence data gathering and root cause identification of death).  Practiced clinical medicine related to ICU and ER settings - treated patients with trauma and life-threatening illnesses and injuries. Show less