Rimzim Taneja

adiiz4@r.postjobfree.com Cell: 313-***-****

https://www.linkedin.com/in/rimzim-taneja-884149120/

Professional Summary

A dedicated pharmaceutical professional with the strong knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, GMP, and GCP. Specialized in clinical pharmacology, psychopharmacology, quality control, and manufacturing along with management of clinical trial.

Work Experience

Senior Clinical Research Coordinator (Oncology), January 2020 - Present

University of Pennsylvania, Philadelphia, Pa

•Assist program managers with initiating study procedures for new industry-sponsored and investigator-initiated clinical trials.

•Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits.

•Coordinate the conduct of complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I - IV clinical trials

•Experience with Data Management in Medidate, Rave (Medidata Certified)

•Participation in the development/maintenance of study specific case report forms and source document tools.

•Organize and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report forms, and research charts.

•Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time.

•Ensure drug accountability and appropriate diary completion.

•Monitor subjects per protocol requirements and ensure adherence to protocol.

•Responsible for IND reporting and/or assisting Sponsor with annual IND reporting.

•Quality control check of Electronic Trial Master File periodically as per the protocol.

•Experience with PK/PD and toxicological data

Clinical Research Specialist, November 2018 – December 2019

Medacta, Erie, PA

•Experience with management and generation of reports of CTMS

•Quality control check of Electronic Trial Master File periodically as per the protocol.

•Experience with USER ACCEPTANCE TESTING.

•Participate with the preparation/collection of all study documents and presentation materials.

•Oversee projects, analyze data, and provide consultation regarding evaluation, interpretation, and advanced data analysis. Ensures the compliance and clinical relevance of data

•Participate in meetings with study sponsor including monitoring visits, investigator meetings, audits, site initiation and study close-outs.

•Support with Study start-up activities and site activation.

•Develop and organize all critical documents related to clinical trials including data base

management. Record database in the EDC.

•Experience managing relationships with physicians and clinical research staff

•Experience with direct support to clinical studies or similar

•Strong networking and Project Management skills

•Regulatory maintenance and submission

•Create and implement standard operating procedures where necessary.

Clinical Research Coordinator, Aug 2016- October 2018

Wayne State University, Detroit MI

•Management of clinical trial study by recruiting Medical Marijuana Patients based on patient screening and deducing patient eligibility.

•Assisted with reviewing SOPs.

•Ensured the study is conducted, recorded and, reported according to the approved protocols, and all applicable regulatory documents.

•Managed and prepared IRB and trial documents (TMF).

•Knowledge of FDA regulations and familiar with Electronic Data Capture

•Experienced with the lab software such as labstats, MS Office, MS Outlook and RedCAP.

•Assessed the drive performance through measures of standard deviation of lane position and corrective

•steering from the simulator black box data using ANOVA, repeated measures design.

•Visual distraction evaluation through eye glances analysis; the measure of longest eye glance duration

•and number of eye glances.

•Assisting in the preparation of manuscripts and presentations.

Graduate Research Assistant, Sept 2017- October 2018

Wayne State University, Detroit, MI

•Developed the experimental design in collaboration with the Lear Corporation Pvt. Ltd.

•Analyzed the data generated from the Driving Simulator statistically.

•Managed clinical trials.

•Organized and maintained track of recruiting subjects by Conducting human subjects’ screenings and deducing eligibility.

•Maintained records and databases.

•Maintained research data, regulatory binders, patient fields and study databases

Medical Scribe, Dec 2015-May 2016

IDS INFOTECH LTD, India

•Accurately and thoroughly documented medical visits and procedures as they were being performed by the physician, including but not limited.

•Physician-dictated diagnoses, prescriptions and instructions for patient or family members for self-care and follow-up.

•Attended trainings on diverse subjects such as information technology, legal, HIPAA and regulatory compliance, billing and coding.

•Collected, organized and prepared catalogue data for physician quality reporting system and other quality improvement efforts and format for submission.

Research Student, Aug 2012-May 2016

Chitkara University, India

•Laboratory work involving pharmaceutical synthesis of drugs such as NSAIDS and formulations, pharmacological toxicities, clinical data studies and protocols, clinical trials, preclinical trials, drug combination/ interaction studies, etc.

•Experienced with the techniques such as pipetting, making solutions (buffers, culture media, etc.), primary and secondary cell culturing, arranging equipment and necessary chemicals required for the experiment.

•Identification and purification of various compounds, Qualitative analysis of different compounds using HPLC, TLC, UV.

•Compounded different Pharmaceutical products including tablets, injectable, syrups, lotions etc.

•Tissue handling, monitoring pharmacological effects of drug on rats (effect of acetylcholine and atropine on intestinal smooth muscle) and human cells and tissues.

•Performed conventional synthesis of Benzimidazole derivatives for their activity as anti-inflammatory agents monitored by TLC for the project.

Accomplishments

•Awarded with Graduate Assistant Scholarship, Wayne State University.

•Appointed as a Treasurer for the AAPS team of the department.

Education

•M.S in Pharmaceutical Sciences, December, 2018 3.9 GPA

Wayne State University. Detroit, MI

•Bachelors in Pharmaceutical Sciences, May, 2016 3.7 GPA

Chitkara University, Patiala India

Contact this candidate