Clinical Research Associate

Mohita Khamar

*** ******* ***, ***** **********, NJ 07080 908-***-**** **************@*****.***

Education

K.B Institute of Pharmaceutical Education and Research, Gujarat, India

Doctor of Pharmacy (Pharm D) Graduation: May 2019

Experience

Cliantha Research

Clinical Research Associate, Ahmedabad, Gujarat February 2018 – March 2019

Conducted monitoring visits for protocol compliance, personnel qualifications assessments and conducted close out visits for sponsors like Mylan and Zydus Cadila for lung cancer drug and topical applicant respectively

Worked with study start up team to conduct site feasibility from varied source of database

Assisted in on-site monitoring of clinical trials including review of source documentation, case report forms, regulatory materials and drug accountability for 3 local sites and worked remotely on 1 out of state site

Reviewed clinical data/information and oversees data correction, assisted study managers in providing interim and final reports and presentations

Reviewed essential/regulatory documents, ensured Investigator Site Files (ISF) are accurate, current and identical to Trial Master File (TMF)

Reviewed lab reports and clinical data contacted sites and discussed laboratory results and actions necessary to ensure protocol consistency and patient safety

Ensured study documentation is completed and properly maintained in accordance with the sponsor protocol, SOPs, GCPs, ICH E6 Guidelines and FDA regulations

Civil Hospital

Doctor of Pharmacy Intern, Gandhinagar, Gujarat May 2018 – May 2019

Patient visits on day to day basis and observed their improvements

Consulted with patients regarding the proper use of medications, potential allergies, adverse drug reactions, and side effects in order to ensure the safety of the patient.

Collected cases and checked patients’ medical background

Filled Patient counseling forms

Projects

Study of Drug use in General Medicine ward at GMERS Hospital, Gandhinagar, Gujarat

Collected data of 900 patients from general medicine ward using WHO indicator to study the variable effects on drug use for 6 months

Used statistical analysis to conclude the results

Additional Skills

GCP (Good Clinical Practice) Certification - Excellent understanding and demonstrated application of GCPs and applicable SOPs

Knowledge of 21 CFR part 11, 50, 54, 56, 58, 312, 314 and 320

Good computer skills: good knowledge of Microsoft Office and other related software

Knowledge of SAS software

Excellent verbal and written communication

Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

Proven flexibility and adaptability

Strong organization and time management skills

Contact this candidate