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Research Assistant

Genozyme Pharmaceuticals
Freshers
3,50,000 - 6,50,000 Per Year
Job is expired
Posted on 16 Mar 19
Job DescriptionLast Date 15 May 19
RESPONSIBILITIES 
  • 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. 
  • All responsibilities are essential to job functions unless noted as non-essential (N) .  
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 
  • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Good therapeutic and protocol knowledge as provided in company training
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a lap top computer
  • Good written and verbal communication skills including good command of English language

Job Type

Interview Type

Face to Face Interview, Telephonic Interview, Group Discussion

Company Description
Genozyme Pharmaceuticals mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the biopharmaceutical and medical device industries in preventing and curing disease.

For over 12 years, Genozyme Pharmaceuticals has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies. We’re also an astute guide, able to simplify that journey for our clients, so safe new products can reach patients more quickly.
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