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Wednesday, 18 May 2016

Job Description


    MAIN OBJECTIVE OF THE JOB:-

    Accountable for all site based support extended to clinical operations team and assigned functional manager.

    JOB RESPONSIBILITIES:-
    Assist in the compilation of all trial related documents during the pre-trial period.
    Follow up with your site team for timely completion of the EDC and will coordinate with delegated site staff to ensure that all the relevant information required in the Case Record Forms are present in the source documents.
    Compile and update the Investigator Site File (ISF).
    Maintain all the study related logs in ISF screening, enrollment and other communication logs, IP &/or blood samples temp logs/ IP accountability logs etc including forwarding all relevant logs to Klinera/Sponsor in a timely manner.
    Manage the inventory of all non-clinical study supplies received &/or returned at site level.
    Assist in scheduling subject visit as per the protocol, by regular telephonic follow-ups/ reminders as applicable.
    Coordinate all lab related activities shipment of samples through the designated courier and ensure timely receipt of the lab reports.

    REQUIRED EDUCATION:-
    A graduate or post-graduate with science &/or medical &/or Pharmaceutical back ground.
    Diploma &/or degree in Clinical Research

    REQUIRED EXPERIENCE:-
    Preferably with past working experience of 6-12 months as CRC.

    REQUIRED SKILL SETS:-
    Excellent interpersonal and organizational skills as well as the ability to effectively prioritize tasks.
    Effective oral and written communication skills. Must be able to communicate effectively with members of other departments
    Computer proficient with sound knowledge of Word, Xcel, Power Point, Microsoft window.

    Desired Candidate Profile

    Education-
    UG:Any Graduate - Any Specialization, Graduation Not Required
    PG:Any Postgraduate - Any Specialization, Post Graduation Not Required
    Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
      Please refer to the Job description above
    Company Profile:
    Klinera Corporation
    Since 2005, KlinEra has partnered with some of the largest pharmaceutical, biotech and device companies, providing innovative and customized clinical trial and research services. 

    To date, we've completed over 50 large-scale Phase 1, 2 and 3 trials successfully by implementing complete clinical trial managementmedical monitoring, data management and site management services all utilizing high quality protocols and Good Clinical Practices (GCP) with a focus on clinical trials in India.

    KlinEra's ability to assume responsibility for all aspects of clinical development programs (e.g.medical writingregulatory support, investigator selection and qualification, clinical trialmanagement, and data analysis regardless of size) puts us at the leading edge of ClinicalResearch Organization (CRO) innovation.

    We have significant experience in the specialized therapeutic areas of cardiology, pediatrics, oncology, and infectious diseases, and our global offices are located in Mumbai, India and San Jose, California.

    Recruiter Name:Ms. Priti Singh
    Contact Company:Klinera Corporation
    Telephone:25091470
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