Novotech India: Senior Clinical Research Associate vacancy in Pharma/ Bioch

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Novotech India: Senior Clinical Research Associate vacancy in Pharma/ Bioch

Awarded as ” CRO of the Year – Australia” for the second year running, and with operations in Australia, New Zealand, India, Malaysia, and Korea, NOVOTECH is the largest Australian owned CRO. Currently working with over 60 local and international clients on leading edge new therapies, NOVOTECH offers a full spectrum of clinical services to the pharmaceutical, biotechnology and medical device industries.

We offer a range of staff benefits, including a competitive salary package, flexible work arrangements, and significant opportunity for professional development. Novotech places strong emphasis on a collaborative and collegiate work environment, giving you the opportunity to make a difference. Regular targeted internal and external training, as well as learning and knowledge sharing opportunities are an integral part of the development program for our staff.
The selection emphasis at Novotech is to recruit qualified and enthusiastic staff who enjoy a results focused and learning environment, who value professional development, and who want to make a strong contribution to the company’s objectives.
If you would like to consolidate your scientific and clinical research knowledge, come and join our growing and dynamic team, delivering quality service to our clients. Develop your career in a fast paced environment whilst working on diverse and unique clinical research projects.

Current Vacancy:
* Post: Senior Clinical Research Associate
* Experience: 3 – 5 Years
* Education: B.Pharma , M.Pharma, M.Sc Bio-Chemistry, Biology, Food Technology
Desired Candidate Profile
* We are looking for an accomplished CRA with a minimum of 3 years monitoring experience, gained in pharma or a CRO.
* It is considered essential that you have a solid knowledge of GCP, national and international regulations and a sound understanding of how they apply to you.
* You will also need to have excellent interpersonal and team skills
* Previous experience in Oncology trials is desirable
* Also you must be willing to travel 50-60% both domestic and international as required.
* Able to join us within 4-6 weeks of signing the contract
* Should not have applied to Novotech in the last 6 months
Job Description
* Assist in managing large scale clinical trial projects or function as project manager for small scale projects, ensuring on-time, on-budget performance
* Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for GCP compliance according to Novotech SOPs and/or client guidelines
* Assist in feasibility process and Perform site facilities inspection
* Negotiate study budgets with investigators
* Obtain, review, and process regulatory and administrative documents from investigator sites
* Coordinate and present at Investigators’ Meetings Participate in other external or internal meetings as required
* Prepare project management reports for clients, project personnel, and Novotech management
* Review and approve monitoring trip reports of CRA-1.Train and mentor CRA – I & II on monitoring, and internal procedures, and query resolution
* Respond to site issue alerted from Sponsor (i.e., non-responsive site, Protocol Deviations concerns, quality issues etc., items that require face to face interaction)
* Update all relevant tracking system on an ongoing basis
* Escalate any issues that require immediate action to the Project manager
If the above sounds like you, and you want to be part of our dynamic team please forward your application via email by close of business to eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%63%61%72%65%65%72%73%69%6e%64%69%61%40%6e%6f%76%6f%74%65%63%68%2d%63%72%6f%2e%63%6f%6d%22%3e%63%61%72%65%65%72%73%69%6e%64%69%61%40%6e%6f%76%6f%74%65%63%68%2d%63%72%6f%2e%63%6f%6d%3c%2f%61%3e%27%29%3b')) mailbox, and Attention: Human Resources Manager, Novotech.
HR Name: Sasita Sophia

Location:Bengaluru/Bangalore, Pune


Prestige Meridian
BANGALORE,Karnataka,India 560001
Email Address: eval(unescape('%64%6f%63%75%6d%65%6e%74%2e%77%72%69%74%65%28%27%3c%61%20%68%72%65%66%3d%22%6d%61%69%6c%74%6f%3a%53%61%73%69%74%61%2e%53%6f%70%68%69%61%40%6e%6f%76%6f%74%65%63%68%2d%63%72%6f%2e%63%6f%6d%22%3e%53%61%73%69%74%61%2e%53%6f%70%68%69%61%40%6e%6f%76%6f%74%65%63%68%2d%63%72%6f%2e%63%6f%6d%3c%2f%61%3e%27%29%3b'))
If the above sounds like you, and you want to be part of our dynamic team please forward your application via email by close of business to mailbox, and Attention: Human Resources Manager, Novotech.

Tuesday, November 30, 2010