KAJAL PATEL MASTERS IN CLINICAL RESEARCH

*** ******* ******, ******* **-94539 510-***-****

nkaydr@r.postjobfree.com

CLINICAL RESEARCH OBJECTIVE

A highly motivated and qualified, team oriented, clinical research professional with a strong understanding of the mechanics involved in clinical trial site management. Additional skills include planning and executing clinical studies and maintaining compliance with Good Clinical Practice (GCPs), Standard Operating procedures (SOPs), and study protocol. Seeking a challenging position as a Clinical Research Assistant.

EDUCATION

Masters of Science – Clinical Research (2010) Cranfield University, U.K.

Bachelors of Medical Laboratory Technology (2008) Sardar Patel University, India

SKILLS AND QUALIFICATIONS

•Resourceful team-player with excellent interpersonal skills and an ability to build rapport with diverse groups.

•Highly motivated, adaptable and flexible, self-starter who takes initiatives with minimal supervision.

•Able to multitask and work on multiple projects simultaneously.

•Experienced in applying clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and ICH guidelines, DCGI, MCC, ANVISA, and CDSCO.

•Sound understanding of the regulations required for the conduction of clinical trials such as 21 CFR312 (Code of Federal Regulations), 21CFR56, 21CFR54, 21CFR50.

•Proficient in the use of Microsoft Word, Excel and PowerPoint.

•Excellent background in performing and coordinating assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs.

• Ability to communicate with quality assurance, data management and the central laboratory department to attain specific study related information and other defined matters.

•Trained to manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

PROFESSIONAL EXPERIENCE

ZYDUS RESEARCH CENTRE, Ahmadabad, India 2010–2011

Clinical Research Assistant

•Coordinated and prepared project plans of clinical trials at in- house Phase-I and Bioavailability/Bioequivalence (BA/BE) facility.

•Projected tracking of ongoing projects (Study start date, panels completed, subjects enrolled and completed the study, Number and type of AE and SAE’s, study completion date etc. and follow-ups of clinical trials).

•Completed SOP compliance check.

•Ensured drug supply, storage and packaging conditions as per the manufacturer requirements and quantity as per the study and regulations requirement, receipt of drug from sponsor for all studies. Check master drug accountability log, dispensing study drug to trial subjects.

• Generated quality control reports for the ongoing study activities, Clinical facility, Drug store, Subjects emergency medicines and checked them for compliance.

•Conducted data collection, source data verification and generated the quality control reports for the Data sheets generated by Clinical Data Management from the source documents and checked reports for the compliance.

•Notified management on deviations from protocol, methodology, medical procedures and processes.

• Monitored study procedures such as study request from the sponsor for starting clinical trial, screening and enrollment of the subjects, check-in day procedures, study day activities, and check-out procedures.

•Partnered with colleagues in multi-functional areas to address routine Phase I and BA/BE study conduction and data management and TMF (Trial Master File) issues.

•Conducting studies according to the ICH-GCP, protocol, and SOP’s requirement.

•Drafted reviewed and revised CRF’s.

• Assisted Principal Investigator in protocol and clinical study report preparation.

•Initiated, maintained, and reconciled Trial Master File for each assigned clinical trial and generated quality control reports.

•Reviewed Informed Consent documents for adherence to GCP and institutional guidelines.

•Reviewed and maintained the regulatory documents required before study conduction such as the (investigators declaration, investigators undertaking and study initiation form, Investigators Boucher, protocol, CRF’s, and amendments if any approved by the regulatory and the independent ethics committee.)

•Managed and Reviewed Study documents (protocol, Informed consent, case report forms, source documentation).

•Ensured that current versions of trial documents and all required trial-related materials and supplies are provided at the investigational site (including logs, manuals, protocols, and study drug supplies).

•Provided administrative support in the ordering and shipping of supplies, generation of checks for study payment, coordination of department training requirements, creation/revision ordered study-specific supplies.

•Verified maintenance and calibration of equipment, and ensured proper logistics of laboratory collections, processing, storage and shipment of specimens.

•IRB submissions submission ( Protocol, IB, ICF, DCGI approval, CTA, Insurance certificate, site specific translations as well back translations of ICF, amendments, CRF, Subject materials).

•Attended meetings held for the study flow improvement and query resolution within Clinical Research Department and Quality Assurance Department.

ZYDUS RESEARCH CENTRE, Ahmadabad, India CO-OP - 8 Months 2010

•Assisted clinical research department in conducting clinical studies according to the ICH-GCP, protocol, and SOP’s.

• Assisted clinical research department in CRF, protocol and clinical study report preparation.

•Initiated, maintained, and reconciled Trial Master File for each assigned clinical trial and generated quality control reports.

•Reviewed Informed Consent documents for adherence to GCP and institutional guidelines.

•Reviewed and maintained the regulatory documents required before study conduction such as the (investigators declaration, investigators undertaking and study initiation from, Investigators Boucher, protocol, CRF’s, and amendments if any approved by the regulatory and the independent ethics committee.)

•Verified maintenance and calibration of equipment, and ensured proper logistics of laboratory collections, processing, storage and shipment of specimens.

*Legal Status: Permanent Resident*

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