How to Apply

  1. Please review the following list for the available positions.
  2. Click on the position title to proceed to our online form.
  3. Choose the desired position from the drop down menu and proceed to the available form. Please type, do not cut and paste
  4. Submit your resume and or a CV in PDF format.
  5. Submit your current picture in the format of .jpg, .gif, .png, or .bmp with the size no more than 200kb.
  6. Submit your cover letter addressing each selection criterion detailed in the position description with specific and comprehensive information supporting each item. (PDF format)
  7. Ensure you have addressed all the questions in the provided form.
  8. Click on SUBMIT to finalize the submission.
  9. Each applicant can apply for more than one position.

 

Should you require further assistances or if you have any questions, contact us at work.with@ptghrsys.com and our staff will respond to your inquiry based on the order in which it was received.

 

PT Ganesha Aggies Jaya is inviting professionals to fill in the following positions:

       
  ​SITE SPECIALIST (please click to apply online)  
 

 

Job Description
Manage and provide a range of clinical research support activities for the Indonesian Research Partnership on Infectious Diseases (INA-RESPOND) in Jakarta, Indonesia (managed by the National Institute of Health Research and Development, Ministry of Health, Indonesia. Candidate must be comfortable working in a fast-paced environment and must be fluent in Bahasa Indonesia and English.


Duties and Responsibilites:
Key duties and responsibilities may include, but are not limited to, the following:

Site Liaison: Serve as the liaison between the INA-RESPOND Secretariat and the investigators and staff of Indonesian clinical research sites, regarding protocol implementation and site activation activities. Track and report site progress, work closely with site staff to resolve issues impacting site performance, and serve as a primary point of contact for sites needing information, training, or other technical assistance. The project’s critical communications processes will be managed through site visits, e-mail, SMS, conference calls, meetings, and maintenance of a web-based portal.


Site Assessment and Preparedness Evaluation: Manage all activities that support site preparedness for protocol activation, implementation, and closeout. Participate in visits to clinical research sites to assess the infrastructure, resources, and training capabilities needed to conduct INA-RESPOND studies. Prepare reports on findings and recommendations. Coordinate development, management and implementation of quality assurance strategies and initiatives.


Training: Plan, coordinate, and help conduct clinical research site staff training and educational efforts in areas including but not limited to: administration, site establishment, regulatory affairs, site operations and record keeping, clinical research, quality management, and good clinical practice (GCP). Coordinate logistics for site visits, meetings, and trainings of clinical research site staff. Participate in development of training and educational materials and general training curricula suitable to specific study and site needs.


Regulatory: Maintain current regulatory knowledge and keep abreast of regulatory procedures and changes. Coordinate development/maintenance of site/country specific regulatory profiles. Liaise with government and regulatory representatives as needed. Oversee the regulatory document and requirements review and tracking process. Review and ensure that site-specific informed consent forms, 1572/Investigator Agreement forms, and other documents are in compliance with regulatory requirements.  Provide mentoring, guidance, and training to site staff to help ensure compliance. 


Conflict and Problem Resolution: Anticipate and identify potential problems and propose preventive measures and solutions. Identify and implement measures to facilitate process improvement.


Site remedial activities: Manage and coordinate any needed site assistance required for remedial or corrective action required as a result of monitoring/auditing by regulatory agencies or entities. Participate as required in site assessment/site initiation visits.


Coordination with staff, clients and collaborators: Serve as a representative of the project and the INA-RESPOND Secretariat, communicating professionally and effectively with the client and all collaborators.
Additional duties as assigned.


Required Skills

  1. Competently manage a very heavy workload, and multiple projects with competing priorities, switching priorities quickly as needs change.
  2. Demonstrate a very high level of technical skill and expertise as pertains to clinical research site support and development.
  3. Demonstrate high proficiency in project planning and organization and proactively anticipate and identify complex issues and problems.
  4. Demonstrate exceptional interpersonal skills and written and verbal communication abilities.
  5. Demonstrate excellent decision-making abilities with competency in making decisions and resolving problems that could have an impact on the Project and/or Secretariat.
  6. Recognize which decisions may have a consequential effect on the Project and/or Secretariat and make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate.
  7. Act as the spokesperson for the Project/Secretariat and consider the implications of input/decisions, ensuring they are communicated appropriately.

Required Experience

  1. A baccalaureate degree from an accredited college or university.  A master degree or equivalent is preferred.
  2. Relevant experience or coursework in public health, biomedical research or other related field.
  3. A minimum of 3 years of increasingly responsible, broad and diversified professional management experience relevant to implementing clinical research or biomedical training programs.
  4. The ability to competently and independently manage all of the above Duties and Responsibilities with minimal guidance and supervision.
  5. Fluent in Bahasa Indonesia and English, both written and spoken.
  6. Previous experience working with United States government funded clinical research projects strongly preferred.