The Indonesia Research Partnership on Infectious Disease (INA-RESPOND) seeks a high quality individual to fill vacant position as a Clinical Research Site Specialist.
INA-RESPOND is a collaborative initiative between United States and Indonesian government institutions formed to promote and conduct high-quality infectious disease clinical research in Indonesia through development of a collaborative, sustainable, and well-recognized research network. INA-RESPOND managed by the National Institute of Health Research and Development (NIHRD), Ministry of Health, Indonesia and Social and Scientific Systems, Inc.
Position Title: Clinical Research Site Specialist
Manage and provide a range of clinical research support activities for the Indonesian Research Partnership on Infectious Diseases (INA-RESPOND) Secretariat in Jakarta, Indonesia (managed by the National Institute of Health Research and Development, Ministry of Health, Indonesia and Social and Scientific Systems, Inc.). Candidate must be comfortable working in a fast-paced environment and must be fluent in Bahasa Indonesia and English.
DUTIES AND RESPONSIBILITIES:
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. Provide mentoring and training to other Secretariat staff, and collaborate closely with staff at SSS headquarters, NIHRD and NIAID.
Additional duties as assigned.
- Competently manage a very heavy workload, and multiple projects with competing priorities, switching priorities quickly as needs change.
- Demonstrate a very high level of technical skill and expertise as pertains to clinical research site support and development.
- Demonstrate high proficiency in project planning and organization and proactively anticipate and identify complex issues and problems.
- Demonstrate exceptional interpersonal skills and written and verbal communication abilities.
- Demonstrate excellent decision-making abilities with competency in making decisions and resolving problems that could have an impact on the Project and/or Secretariat.
- 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.
- Act as the spokesperson for the Project/Secretariat and consider the implications of input/decisions, ensuring they are communicated appropriately.
- A baccalaureate degree from an accredited college or university. A master degree or equivalent is preferred.
- Relevant experience or coursework in public health, biomedical research or other related field.
- A minimum of 3 years of increasingly responsible, broad and diversified professional management experience relevant to implementing clinical research or biomedical training programs.
- The ability to competently and independently manage all of the above Duties and Responsibilities with minimal guidance and supervision.
- Fluent in Bahasa Indonesia and English, both written and spoken.
- Previous experience working with United States government funded clinical research projects strongly preferred.
To apply, please email your Resume/CV to Meity Siahaan at MSiahaan@s-3.com
Please write down the position that you'd like to apply in the subject line of your email.
Interested parties should respond immediately.
Application closing date: October 20, 2014
Only shortlisted candidates will be contacted.
No phone and e-mail inquiries, please.
More information about us can be found on the following websites :
INA-RESPOND : http://www.ina-respond.net/Social & Scientific Systems, Inc : Social & Scientific Systems, Inc.