Social & Scientific Systems, Inc. is looking for a Site Specialist,
Jakarta Based, with the following requirements and job description :
Job Description
Manage and provide a range of clinical research support activities for
the Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
and South East Asia Infectious Disease Clinical Research Network
(SEAICRN) Operations Center in Jakarta, Indonesia (managed by Social and
Scientific Systems, Inc (SSS). Dutiesinclude but are not limited to:
provide clinical research site training and support for protocol
implementation and site development activities; conduct site visits;
conduct quality management activities, manage work with other members of
the operations center to ensure that all protocol related activities
are completed according to client timelines; provide support to the
protocol development team; conduct review of protocol documents; assist
with development of project budgets; serve as a data manager. 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 SSS 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 Support: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 and SEAICRNstudies. 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.
Data Management: Responsible for Case Report Form (CRF) design,
development, and maintenance. Coordinate, prepare, and provide training
of all key data management-related study documents including CRF
completion instructions, Data Management Guidelines, CRF Annotation,
Data Entry Guidelines. Coordinate data entry screen testing, edit check
programming and testing. Develop, generate and manage data queries,
reports, and other data related activities. Provide support to clinical
site staff regarding queries of data management system, develop site
training materials and conduct training sessions. Plan and implement QC
steps, such as checking tables, figures, and listings, verifying data
entry, and reconciling text and tables.
Protocol Development and Implementation:Manage activities associated
with protocol development and implementation including coordinating and
providing guidance and support to protocol teams. Set up call/meeting
schedules, create call/meeting agendas in consultation with the client,
run calls/meetings, provide call/meeting summaries, manage timelines,
and otherwise collaborate with team members in order to meet
objectives. Coordinate the writing of and edit and disseminate the
protocol. Draft protocol-related documents such as informed consent
forms, manuals of operations, and other documents as needed. Contribute
to the creation and review of CRFs and the development of site budgets.
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 SSS staff, INA-RESPOND members, SEAICRN members,
Consultants, and Other Contractors and Regulatory Agencies:Serve as a
representative of the project and SSS, communicating professionally and
effectively with the client and all collaborators. Provide mentoring and
training to other OperationsCenter staff, and collaborate closely with
staff in other SSS country offices.
Additional duties as assigned.
Required Skills
* Competently manage a very heavy workload, and multiple projects with
competing priorities, switching priorities quickly as needs change. Must
be comfortable working in quick-paced environment.
* 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 experience in preparation and management of budgets
* 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 SSS.
* Recognize which decisions may have a consequential effect on the
Project and/or SSS and make decisions based on experience, skill, and
situation, consulting with and/or informing others as appropriate.
* Act as the spokesperson for the Project/SSS and consider the
implications of input/decisions, ensuring they are communicated
appropriately.
Required Experience
* A baccalaureatedegree from an accredited college or university. A
master’s or doctorate level degree or equivalent is preferred.
* Relevant experience or coursework in public health, biomedical research or other related field.
* A minimum of 5years 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 languages, 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 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: August 10, 2012.
Only shortlisted candidates will be contacted.
No phone and e-mail inquiries, please.
More information about Social & Scientific Systems, Inccan be found on our website http://www.s-3.com/
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