Clinical Research Associate 1 Quintiles-Bengaluru/Bangalore , Mumbai , Ahmedabad , Delhi/NCR(National Capital Region) , Chennai

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. 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. May support start-up phase.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Build awareness of features and opportunities of study to site.
Collaborate and liaise with study team members for project execution support as appropriate.

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Helping to Speed Cures and Treatments to Patients

The U.S. Food and Drug Administration is committed to helping deliver innovative, safe, and effective treatments and cures to the patients who need them as quickly as possible. To achieve this goal, we have implemented a variety of expedited review programs and are working to help shorten the development time before a product is even submitted for FDA review.

Accomplishments: Drugs

As a result of these efforts, in 2014 alone, FDA approved 51 new molecular entities and biological products (41 by our Center for Drug Evaluation and Research and 10 by our Center for Biological Evaluation and Research). These approvals included major therapeutic advances in the treatment of cancer, hepatitis C and type-2 diabetes. They also included vaccines for meningococcus type B, and more new orphan drugs for rare diseases than any previous year in our history.

Accomplishments: Devices

We’ve also made strides with medical devices. As a result of activities coordinated by CDRH Innovation, and programmatic improvements and innovative use of our existing approval and clearance pathways, many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade. Read More

FDA approves Darzalex for patients with previously treated multiple myeloma

Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and cause other bone or kidney problems. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year.

“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”

Darzalex injection, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.

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