Overview

KRKA pharmaceutical factory is looking for an employee for the vacant position of Clinical Research Coordinator (CRC).
The CRC will work with the authorized state body for IMPs approvals in Armenia, including the Ministry of Health, as well as doctors and lawyers, and will be responsible for the preparation of all documents necessary for the implementation of clinical trials (CT), obtaining the permission of CTs, and their implementation. for organization and monitoring.
The CRC must be able to propose, design, prepare, direct, coordinate, implement and monitor research-related activities and thus perform the work economically beneficial way and with optimum efficiency.

Responsibilities:
  • Prepare clinical research documents with the head office of KRKA and submit them to the state authorized body for approval in order to obtain the certificates on time;
  • Organize, if necessary, tenders for contract research organizations or other companies involved in conducting clinical research (economically beneficial and with optimal efficiency);
  • Ensure that clinical studies and related activities are performed in accordance with Good Clinical Practice, local laws and regulations, and corporate policies, procedures and Code;
  • Prepare cost estimation for clinical study in a rational way and realization in an economical way and with optimal efficiency within the approved budget;
  • Cooperate in the selection of proper investigator sites and investigators;
  • Cooperate in organising investigator meetings;
  • Ensure together with investigators the best recruitment practice for studies;
  • Instruct research staff in scientific and procedural aspects of study management, including standards of care, informed consent procedures and documentation procedures (filling out/completing CRFs and other documentation);
  • Collaborate in the management of day-to-day research-related activities, including problem-solving, protocol management, and communication with laboratories;
  • Identify protocol violations, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions;
  • Be able to develop local Standard Operating Procedure (SOP) and be guided by it;
  • Know the procedures for importing investigational pharmaceutical products (IMPs);
  • Know the Armenian and European laws and guidelines regulating mining research;
  • Create a clinical research budget and report regularly;
  • Monitor clinical research and compile reports;
  • Be able to perform multitasking within the set deadlines.
Required Qualifications:
  • Higher pharmaceutical or medical education;
  • Work experience in the field of clinical research will be an advantage;
  • Excellent knowledge of Armenian, English and Russian languages;
  • Ability to work effectively in a team;
  • Excellent interpersonal, communication and networking skills;
  • Computer skills (MS Word, MS Excel, MS Outlook and MS PowerPoint).

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