Assisting in EC Submission, Notification and follow-up the approvals

Dr.M.Mohammed.Asif

Mobile: +919*********

Email: ************@*********.***

OBJECTIVE

Aiming for career enhancements in pharmaceutical and clinical research

field which provides challenging assignment and environment that encourages

continuous learning and provides exposure to new ideas.

PROFESSIONAL EXPERIENCE:

Having 1year 3months of work experience in Clinical Research Operations as

Clinical Research Coordinator, At Mediciti Hospitals, Hyderabad, and

Working According to ICH, GCP guidelines, Schedule Y, ICMR guidelines and

applicable regulatory guidelines.

Got ICH-GCP certificate from quintiles in 2013.

Having 4years 3months of experience in clinical practice.

Worked as Duty medical officer at medicare hospital.

Worked as DMO at kamineni hospital for 1 year.

Working as night duty doctor at JBI Hospital since more than a year.

Least number of referrals in my carrier.

JOB RESPONSIBILITIES:

> Assisting the Principal Investigator in feasibility and interact with

Sponsors and CROs.

> Assisting in EC Submission, Notification and follow-up the approvals

and documents for the study. Coordinate the submission of Protocol,

Investigator undertaking(IU),different languages of Informed Consent

Forms (ICFs), Clinical Investigator's Brochure (CIB), Serious Adverse

Event (SAE) forms, CIOMS forms, Interim and final report of the study.

> Assisting in Site Initiation and Essential Documents Completion.

> Review of Database for potential study subjects.

> Maintaining regulatory documents.

> Assist investigator in Screening, recruiting, enrolling and

consenting patients.

> Patient scheduling, coordinating the screening and enrollment of

the patients according to the protocol, Good Clinical Practice

(GCP), EC, Regulatory guidelines.

> Maintaining source documents and ensuring quality of eCRF.

> Assist investigator and the monitor conducting monitoring, site-

initiation, and close-out visits with clinical research monitors.

> Ensure proper study product storage and accountability.

> Subjects screening, randomization, assigning drug and

terminating through IVRS systems.

> Determine storage and supply needs.

> Recording and reporting SAE'S/AE's to Sponsor and EC

> Regular updating of Trial Master File, Maintaining site logs &

source documents.

> Reports patient status at site to Monitor/ Project manager.

> Data entering in to the database (ORACLE RDC, EDC) timely and

efficient manner. And resolving queries

> Resolving DCF queries as per the sponsor specified time lines

CLINICAL TRIALS COORDINATING:

1. Phase 3 To evaluate cardiovascular out comes with DPP-4

2. Phase III Acute atrial fibrillation study

3. safety and efficacy of Boceprevirin ch.hepatitis patients

EDC (ELECTRONIC DATA CAPTURE) RESPONSIBILITIES:

> Comprehensive Data entry in oracle RDC and EDC, with in the Sponsor

specified timelines .

> Query management functionality for data capture and data cleaning.

> Managing Log forms

IM ATTENDED

. Attended Asia Pacific Level Investigator meeting at Gurgaon in july

2012.

. Attended National Level Investigator meeting at chennai in May 2012.

. Attended National Level Investigator meeting at Bangalore in March

2012.

EDUCATIONAL PRO

Degree College & University Scores Year of

passing

M.Sc in ICRI, Bangalore, 2009

Clinical Cranfield University, 60%

Research UK

PG Diploma in Institute of clinical 2007

Pharmaceutica Research, Bangalore. 60%

l Management

Bachelor of Govt. Nizamia Medical 2006

Unani College Hyd, NTR

Medicine and University Of Health 64%

Surgery Sciences, Vijayawada.

S.S.G.S government

XII standard college, 1999

Guntakal. 53.2%

PERSONAL PROFILE

Date of Birth : 09-04-1982

Marital Status : Married

Nationality : Indian

Languages Known : English, Hindi and Telugu.

Address : Dr.M.Mohd.Asif

H.No.9/335 ground floor

Andhra bank road,near kranti transport,

Guntakal.515801

REFERENCE

1. Dr P. Naveen Chander Reddy MD.,

Medical Coordinator,

Mediciti Research Cell

Mediciti hospital,

Opp:AP Secretariat,

Hyderabad-500063, A.P.

Mobile: 984**-*****

Landline: 040********

Email:***************@*****.**.**

Date:

Place: HYDERABAD (Dr.M.Mohd.Asif)

Contact this candidate