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.
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Job Description
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.
Required Skills
- 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.
Required Experience
- 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.
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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.
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: September 12, 2014
Only shortlisted candidates will be contacted.
