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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Position Title: Clinical Research Site Specialist
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.
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
Social & Scientific
Systems, Inc : Social & Scientific Systems, Inc.
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