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Job desc: Site management to initiate qualified and effective study conduct.
Based: Upon request from Sponsors
We recommend this position to be filled by person with health science educational background (medicine, community health, pharmacist, biomedic), preferably Indonesian. Here are several requirements for this vacancy:

1. GPA index is more than 3.00,
2. Excellence communication skill (both written and oral),
3. Numeracy and an eye for details,
4. Able to motivate others, and
5. Good organizational, computer and administrative skill (the job might involve a lot of documentation and recording of information through computerized processes such as clinical trial management system (CTMS), electronic data capture (EDC) and Microsoft Office).

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Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Requirements

• Minimum of a bachelor’s degree; Health or life science related field preferred (i.e. Pharmacy, MD);
• Solid knowledge of GCP, national and international regulations
• Fluent in English;
• Able to work independent and collaborate with various role players;
• Willing to travel approximately 60-80% nationally;
• Familiarity with Microsoft® Office; and
• Strong communication and presentation skills.

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