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.
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.
Interested parties should respond immediately.
Application closing date: July 13, 2013 Only shortlisted candidates will be contacted.
