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Friday 27 May 2016

Sr, Clinical Trial Assistant Fulltime Permanent Role

Wissen Infotech Pvt. Ltd.
1 - 3 yrs 
Bengaluru/Bangalore

Job Description

    Candidates with Site Monitoring Visits (TRIALS) only need to apply

    No BA- BE Studies

    POSITION SUMMARY:

    Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. 
    Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements 

    RESPONSIBILITIES: 

    Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and goodclinical practice. 
    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 to Clinical Project Manager (CPM), Clinical Research Specialist CRS) and/or line manager. 
    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. 
    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. 
    Act as a mentor for clinical staff including conducting co-monitoring and training visits. 
    May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: 

    Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines 
    Strong 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 laptop computer 
    Strong written and verbal communication skills including good command of English language 
    Strong organizational and problem-solving skills 
    Effective time management skills 
    Ability to manage competing priorities 
    Good mentoring and training skills 
    Ability to establish and maintain effective working relationships with coworkers, managers and clients 

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE: 

    Bachelor's degree in a health care or other scientific discipline or educational equivalent and 2 5 years of on-site monitoring experience; or equivalent combination of education, training and experience
Company Profile:
Wissen Infotech Pvt. Ltd.

Established in 2000 in US, we have global offices in US, UK, Europe, Mexico, Middle East, and India, with best in class infrastructure and development facilities spread across globe. We are an end to end solution provider in Banking & Financial Services, Telecom, Healthcare & Retail verticals and have successfully delivered $350 million worth of projects. We offer an array of services that includes Application Development, Quality AssurAboutusance, Infrastructure Management and ERP. Wissen is uniquely positioned to help you with your needs in building enterprise systems, adopting a visualisation and business intelligence stack or implementing a Digital strategy. Our expertise in a wide range of technologies such as Mobility, Analytics, Internet Of Things, Cloud Management Embedded Systems, Bigdata and Hadoop and Remote Infrastructure Management allow us to help you make an informed decision and leverage the most appropriate technology for the problem.

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