Pharmacy Clinical Research

Dharmendar Gupta

Contact: +91-730*******

Email Id: ac9np5@r.postjobfree.com

Permanent address: Current address: Vill-Imiliya, Post- Rasulpur Adajan

Dist-Ghazipur, Uttar Pradesh SURAT

233302

OBJECTIVE: To apply my knowledge, skills and understanding to my work and contribute towards the growth of the organization.

AREAS OF INTEREST: In Clinical research.

EDUCATIONAL QUALIFICATION:

Qualification

University/Board

Year

B.Pharm

U.P.T.U.

2012-16

Intermediate

C.B.S.E. Board

2008-10

High School

C.B.S.E Board

2008

OTHER QUALIFICATIONS AND CERTIFICATIONS:

PGD in clinical research from Indian health BPO (Hyderabad).

Good clinical practise (GCP) certified.

RDC certified (EDC Software) Of NOVARTIS.

Handle Cenduit software of NOVARTIS for IWRS call.

JOB EXPERIENCE :(2 years)

Currently working in Global studies of Novartis as a Consultant-CRC of TECH-OBSERVER INDIA PVT. LTD (Dec 2018 to Till Date).

Eighteen months worked in MICRO THERAPEUTIC RESEARCH LAB. PVT. LTD. CHENNAI as a CRA (Jan 2017 to Jul 2018).

TECHNICAL SKILLS:

A good working knowledge of Windows operating systems.

Software’s handled: MS-Office (MS-Word, PowerPoint and Excel).

AWARDS AND ACADEMIC ACHIEVEMENT:

Won 2nd position in study search and sell competition.

Won 2nd position in quiz general pharmaceutical knowledge competition.

Won SKIT Certificate in college annual function.

Member of SOCIETY FOR ETHNOPHARMACOLOGY (SFE-INDIA).

ANTI-RAGGING INCHARGE in college campus up to 3 years.

JOB DISCRIPTION:-

1.IN CRC.

Coordinate with study monitor during the site selection, initiation, routine monitoring visits and site close out visit activities.

Developing, implementing and maintaining study documents, timelines, files, communication tools, and systems used in conducting a project.

Maintain the study related Logs and Forms: Screening, Enrolment, Drug Accountability, Temperature and other communication logs.

Follow up with study team for timely completion of the source documents and ensuring that all the relevant information required in the CRF are present in the source document.

Screening, Enrolment, Drug Accountability, Temperature and other communication logs.

Follow up with study team for timely completion of the source documents and ensuring that all the relevant information required in the CRF are present in the source document.

Assist the investigating team in the process of administering the informed consent to subjects and explain in details about the patient information sheet & patient diaries.

Coordinate Screening and recruitment of patients based on protocol eligibility criteria. Coordinate all patient-related appointments.

Maintain subject related source documents like Visit notes, Medical history, laboratory Investigations, ECG reports and other documents (all signed and Dated by Investigator or Designee) as required in the Protocol.

Expertise in handling “E-Systems” of clinical trials like ECRF (Inform 4.6 Version), IWRS (ClinPhone & Cenduit).

Perform data entry into EDC within timelines specified by sponsor (within 48 hours of subject follow up visit). Resolve Data Clarification Forms in consultation with the investigator.

Maintaining the Temperature Range of Investigational Product as per Protocol. Performing Study Drug Accountability for each subject.

Responsible for the management of study materials and investigational product: ordering, tracking, storage, dispensing, reconciliation and destruction.

Coordinate all lab related activities between Local/Central Laboratory and Courier for shipment of Samples.

Updating and maintaining the Investigator Site File and sending progress reports to CRO.

2. IN CRA (BA/BE Study).

Performing custodian duties as per relevant SOPs and Bio study protocol including subject in, check-out procedure, Performing Alcohol Breath test, Screening of urine sample for drug of abuse, Monitor movement of subject for compliances to posture and other restrictions.

Monitoring safety of subjects during their in-house stay and post study requirements.

Arrangement for conducting pre study meeting.

Responsible for Administration of investigational products.

Responsible for ensuring preparation of study related documents (clinical study updates) with in stipulated time and as per the applicable regulatory requirements.

Responsible for ensuring the cleanliness of housing and responsible for weighing, serving and meal distribution of the subjects.

Follow up of major and minor malfunctioning of clinical equipment’s and to ensure the compilation of study specific documents in TMF, before, during and after commencement the study.

Ensure making of correct and on-line entries of the relevant forms as per SOP and review of the respective study specific documents.

Overall responsibility for pharmacy management including the maintenance of pharmacy equipment’s.

Responsible for study drug Procurement, Receipt, Storage, Drug dispensing, Destruction and Archival.

Responsible for obtaining/requesting for randomization schedule.

Follow up of major malfunctioning of equipment’s in pharmacy and handling crisis management in pharmacy.

Other responsibilities as assigned by the management of head of the department.

PARTICIPATION IN SEMINAR:

Attended two days seminar in IIT BHU (Spirit15) on Frontiers of Pharmaceutical Sciences & Technology in 2015 at Banaras Hindu University Varanasi.

Participate and won national seminar on Global Prospective of Phytopharmaceutical in Pharmacy held at Faculty of Pharmacy, Naraina Group of Institutions 2014 at Kanpur.

Participated and won national seminar on Pharmacy: Gateway towards health & Management held on World Pharmacist Day in 2013 at Goel Institute of Pharmacy & Sciences Lucknow.

Attended one day seminar by Institute of Pharmaceutical Science & Research (IPSR) on Nano Technology a Targeted Drug Delivery System in 2015 at Unnao.

PERSONAL DETAILS:

Name : Dharmendar Gupta

Father’s Name : Gopichand Gupta

Address : VILL- Imiliya, POST- Rasulpur, DIST. - Ghazipur, UP.

Marital Status : Single

Languages : English, Hindi.

DECLARATION:

I, Dharmendar Gupta, hereby declare that all information furnished by me is true to the best of my knowledge.

Date: (Dharmendar Gupta)

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