Hiring For Clinical Research Associate, @ Kartik Kumar Joshi

Job Description

Tasks vary depending on your employer and level of experience. However, you'll typically need to:

• develop and write trial protocols (outlining purpose and methodology)
• present trial protocols to a steering committee
• design data collection forms, known as case report forms (CRFs)
• coordinate with the ethics committee, which safeguards the rights, safety and well being of all trial subjects
• manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• identify and assess the suitability of facilities to use as the clinical trial site
• identify/select an investigator who will be responsible for conducting the trial at the trial site
• liaise with doctors, consultants or investigators on conducting the trial
• set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigation medicinal product (IMP)
• train the site staff to trial-specific industry standards
• monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
• verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• collect completed CRFs from hospitals and general practices
• write visit reports and file and collate trial documentation and reports
• meet with team members to discuss on-going trials, results and any trends or adverse events
• ensure all unused trial supplies are accounted for
• close down trial sites on completion of the trial
• discuss results with a medical statistician, who writes technical trial reports
• archive study documentation and correspondence
• prepare final reports and occasionally manuscripts for publication.
• Product development and process validation experience, including introduction of new product to the site and optimisation of existing manufacturing methods.
• Sourcing of external R&D laboratories for development and validation of new analytical test methods.
• Development and validation of analytical methods using various analytical techniques including HPLC, Dissolution and Wet Chemistry in line with current guidelines.
• Lead and take ownership of the analytical aspects of various in-house and external R&D projects including writing and reviewing related protocols, reports and test methods.
• Managing aspects of stability programmers conducted internally and externally for assigned projects.
• Supporting Regulatory Affairs during the submission of new dossiers and responses to deficiencies from Competent Authorities for new applications and variations of existing licenses.
•  Assist when necessary in formulation support activities of in-house newly developed products
• Effective completion of Analytical Method Verification and technical transfers as requested.
• Ensure equipment is maintained in accordance with cGMP requirements in terms of operation, raw data processing, maintenance, calibration and qualification.
• Collaborate with team members and other department functions to achieve common goals
• Provide training to junior R&D personnel in terms of Analytical method development, verification and validation.
• To Prepare, Review and Check basic and advanced area documentation (Laboratory notebooks, laboratory logbooks, SOPs, change controls and Specification Sheets).
• To ensure that work is carried out in compliance with the organisations quality system.

 

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Employement Category:

Employement Type: Full time
Industry: Medical / Healthcare
Role Category: R&D / Product DesignPharmacist / Medical Representative
Functional Area: Not Applicable
Role/Responsibilies: Hiring For Clinical Research Associate,

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Keyskills:   lab supervision medical research quality assurance microbiology project management lab management research operations clinical research lab testing research development