Social & Scientific Systems is seeking a Clinical Research Site Specialist

Social &
Scientific Systems is seeking a Clinical Research Site Specialist to 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).  Candidate must be comfortable working in a
fast-paced environment and must be fluent in Bahasa Indonesia and English.


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).  Duties include 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 SEAICRN 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.
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 Operations Center 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
baccalaureate degree 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 5 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 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 Meity
Siahaan, Finance and Admin Manager 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: July 13, 2013 Only shortlisted candidates will be contacted.