PT. Prodia DiaCRO Laboratories (Prodia the CRO) is the first local Indonesian Contract Research Organization that established in 2007. Since then, Prodia the CRO has been committed in developing and contributing to accelerate drug development processes in field of Clinical Trial, in collaboration with over 500 investigators and 146 sites nationwide. Working together with more than 100 global companies worldwide, Prodia the CRO has help clients bringing over 200 trials to improve the wellness of people.
Since we offer broad range of services to our customers worldwide, we certainly understand that our employees are the key to our success. Therefore, we offer our employees with various benefits as follows:
Prodia the CRO is now looking for a vibrant candidate to fill the position as follows:
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:
- GPA index is more than 3.00,
- Excellence communication skill (both written and oral),
- Numeracy and an eye for details,
- Able to motivate others, and
- 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).
- 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.
- 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.
This is an excellent opportunity for you to experience working with huge number of sponsor in conducting clinical trial in Indonesia. Send your complete CV, graduation certificate and license to: firstname.lastname@example.org. Looking forward to seeing you working with us! To review our company profile, please visit www.prodiathecro.com.