Clinical Research Analyst

Job Description
1) screening of patients and developing referral mapping of patients
2) Schedule patient visits
3) Proper documentation and reporting according to required standards
4) Efficient patient follow-up
5) Study closure and Submission of report

Experience : 0 - 5 Years
Location : Bengaluru/Bangalore
Executive Name: Reema
Reference ID : WIN097
Company Name:Winpro Technologies
Direct WALK-IN

Venue: From Monday to Saturday in-between 10am to 6pm.

Add: WINPRO TECHNOLOGIES, # 25, 2ND Floor, 4th Cross, Opp to Swarna Bharti Co-Operative Bank, Jayanagar 7th Block, K.R. Road, Bangalore-82.

Cont # 080-32020520/ 9241763009.

Website: http://www.winprotechnologies.co.in

Clinical Research- Assistant

Job Description

Data Management, validation of CRFs, CRF designing, Discrepency checking, updation & varification of DCF, Interaction with Client, independently handling of Clinical Trial Project., assisting Consultant Clinical Research in other research job.

Company Profile

1st NABH with NABL, CAP & ISO 9001-2000,14001, OHSAS 18001 certified primier cardiac care centre. This State of Art, internationally reputed hospital belongs to C.K.Birla group.

Experience : 1 - 3 Years

Location : Kolkata

Company Name: B.M.BIRLA HEART RESEARCH CENTRE

Executive Name: Ramesh Lall/Sounak Sengupta

Address

B M Birla heart research centre
1/1, National Library Avenue, Kolkata - 700054
KOLKATA,West Bengal,India 700054

Email Address : hrd.bmbhrc@bmbhrc.com

Telephone : 33-91-30403035

Website : http://www.birlaheart.org

Istodax - Recently approved Drug by FDA

Generic Name : romidepsin
Date of Approval: November 5, 2009
Company : Gloucester Pharmaceuticals

The U.S. Food and Drug Administration (FDA) approved Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Istodax is a prescription medicine used to treat people with a type of cancer called cutaneous T-cell lymphoma (CTCL) after at least one other type of medicine by mouth or injection has been tried. It is not known if Istodax is safe and effective in children under 18 years of age.

Link: http://www.drugs.com/istodax.html

Pennsaid - Recently Approved Drug by FDA

Generic Name: diclofenac sodium topical solution
Date of Approval: November 4, 2009
Company: Nuvo Research Inc.

The U.S. Food and Drug Administration (FDA) has approved Pennsaid Topical Solution (diclofenac sodium topical solution) for the treatment of the signs and symptoms of osteoarthritis of the knee.
Pennsaid Topical Solution is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause inflammation and pain in the body.

Pennsaid is used to treat the signs and symptoms of osteoarthritis of the knee(s).

Link: http://www.drugs.com/pennsaid.html

Clinical Research Associate

Job Description

Planning and managing the activities according to top management strategic decision making

• Over see and do all the activities as follows

1. Input to protocol from DM perspective

2. Design database as per the protocol

3. Manage data entry/ verification/ Edit/ Cleaning

4. Retrieve data for analysis

5. Review CSR frm DM perspective

• Keep all the documents properly in data management master file by study wise respectively.

Desired Candidate Profile
Planning and managing the activities according to top management strategic decision making

• Over see and do all the activities as follows
• Keep all the documents properly in data management master file by study wise respectively.

Experience : 1 - 2 Years
Location : Mumbai
Compensation: Rupees 1,50,000 - 2,50,000
Company Name: wockhardt limited
Website : http://www.wockhardt.com

Lysteda - Recently approved Drug by FDA

Generic Name : tranexamic acid
Date of Approval : November 13, 2009
Company : Xanodyne Pharmaceuticals, Inc.

The U.S. Food and Drug Administration (FDA) has approved Lysteda (tranexamic acid) for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.

Lysteda is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. Lysteda does not contain any hormones. On average, Lysteda has been shown to lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop your period. Lysteda is taken only during your period and is not meant to treat pre-menstrual symptoms.

Link: http://www.drugs.com/lysteda.html

Infonetica’s Research Ethics Database (RED) - Introduction

RED was originally developed by Infonetica Research Systems for NRES (http://www.nres.npsa.nhs.uk/) - the National Research Ethics Service in the UK. It has now been licensed and is available worldwide to Institutional Review Boards (IRBs) and Ethics Committees. RED provides administrative support for IRB/ethics committee administrators, and regional and national management information. It is available as a single, multi-site or national system, providing each administrator with their own unique view of their IRB/committee.


RED is a complete, web-based solution for research ethics application processing, handling both committee administrator tasks and management information. When used in conjunction with the Integrated Online Form Framework, the system provides an ‘end to end’ solution that also handles the information requirements of the applicant.

RED allows administrators to manage the application process to an IRB/ethics committee. It constantly monitors the elapsed time on all projects simultaneously, warning of studies that are in danger of over running the contracted timescales. RED takes a stepwise approach to managing every part of the process taking into account, provisional decisions, rejections, approvals, amendments and site specific assessments.

Nationally RED can provide information on every IRB/committee and comes with a powerful suite of Management Reports It gives managers important real time information on any studies that are in danger of breaching the timescales set by the EU directive – allowing managers to intervene early on to avoid any breaches before they happen. The report suite also allows trend analysis, giving the ability for long-term capacity planning in the ethics committee network.

Link: http://www.infonetica.net/content.aspx?id=3&type=content