Regulatory Associate

• Jan 2022 - Present

• Creating and maintaining the Investigator Site File for all studies awarded to Pharmaron CPC.• Performing IRB submissions.• Generating all essential documents(i.e., Form FDA 1572, Financial Disclosure Forms, etc.) for submission to sponsor.• Reporting deviations/violations and Serious Adverse Events to IRB.• Ensuring IND safety reports are submitted to the PI and IRB for review.• Ensuring all staff members complete protocol specific training and sign the delegation of authority log prior to performing any study related duties.• Posting each version of the IRB approved protocol, informed consent form and investigator brochure for all staff to review.• Preparing delegation of authority log for each study and updating the codes of tasks incompliance with the IRB approved protocol.• Creating protocol specific training certificates for each version of the IRB approved protocol and distributing to applicable project team members.• Ensuring all study closeout reports are submitted to the IRB at the end of the study.• Working Closely with Clinical Trial Monitors during monitoring visits.

Clinical Service Coordinator

• Feb 2021 - Dec 2021

Conducted screening activities of potential subjects which includes but not limited to:• Providing an overview of the study to the subjects.• Obtaining informed Consent• Reviewing medical history, inclusion/exclusion criteria• Confirming demographic information• Assisting in obtaining protocol required screening tests• Responding to subjects queries• Completion of required paperwork• Assisting with outpatient follow up visits• Working with management to develop optimal workflow of screening activities.• Sending subjects check request to accounting department.• Performing administrative tasks to support team members with clinical trial execution as needed.

Clinical Trial Assistant

• Oct 2020 - Jan 2021

Quality Control of source documents. Quality Control of laboratory test results of study participants. Creating screening and inpatient subject binders.

Clinical Extern

• Jul 2019 - Aug 2019

Rotated on patients at the University of Maryland Baltimore Washington Medical Center.Interacted with patients (around twelve patients per day) at an outpatient clinic. Collected patienthistory, performed physical exams, presented patient profiles to the supervising doctor, andsuggested appropriate diagnostic tests. Provided assessments and plans to the supervisingdoctor before rounding on the patients with the doctor. Performed preoperative evaluations.Maintained electronic medical records.

Clinical Extern

• Jun 2019 - Jul 2019

Involved in all aspects of patient care. Interacted with patients (around sixteen patients per day)at an outpatient clinic. Collected detailed histories and performed examinations undersupervision. Formulated management plans after discussion with the attending physicians.Used EMR system to write H&Ps, progress notes, and discharge summaries. Observed avariety of conditions including Diabetes, HTN, depression and anxiety. Involved in all aspects of patient care. Interacted with patients (around sixteen patients per day)at an outpatient clinic. Collected detailed histories and performed examinations undersupervision. Formulated management plans after discussion with the attending physicians.Used EMR system to write H&Ps, progress notes, and discharge summaries. Observed avariety of conditions including Diabetes, HTN, depression and anxiety.

Clinical Extern

• May 2019 - Jun 2019

Interacted with patients (around fifteen patients per day) at an outpatient clinic. Collected patienthistory, performed physical exams, presented patient profiles and differential diagnoses to thesupervising doctor. Suggested appropriate diagnostic tests and imaging. Interacted with patients (around fifteen patients per day) at an outpatient clinic. Collected patienthistory, performed physical exams, presented patient profiles and differential diagnoses to thesupervising doctor. Suggested appropriate diagnostic tests and imaging.

Medical Officer

• Nov 2013 - Aug 2014

Student Intern

• Nov 2012 - Oct 2013

· Hands on clinical clerkship in medicine (19 weeks), surgery (19 weeks), obstetrics &gynecology including community medicine (14 weeks).· Performed various procedures including lumber puncture, paracentesis, thoracentesis,NG tube insertion, urinary catheterization and intravenous cannulation during medicineclerkship.· Assisted in many surgical procedures including appendectomy, cholecystectomy,herniotomy, herniorrhaphy, Baker cystectomy and laparotomy during surgery clerkship.· Assisted in procedures such as C-section, TAH with bilateral salpingo-oophorectomyand DE & C during obstetrics& gynecology clerkship.· Assisted in collecting history, performing examination of the patients and orderingnecessary laboratory tests. Evaluated patients based on history and test results andprovided appropriate management.· Presented patient profile to the Professors.