Responsible for conducting and coordinating AFIRE clinical research study for the Indonesia Research Partnership on Infectious Diseases (INA-RESPOND). The study will be held at RSUP Persahabatan, Jakarta, RSPI Prof Dr Sulianti Saroso, Jakarta, RSUP dr Hasan Sadikin, Bandung, RSUP Dr Kariadi, Semarang, RSUP drSardjito, RSUD drSoetomo, Surabaya, RSUP Sanglah, Denpasar, and RSUP DrWahidinSudirohusodo, Makassar.
DUTIES AND RESPONSIBILITIES:
- Coordinates all aspects of the study and study staff, as directed and delegated by site PI
- Screens subjects / determines subject eligibility
- Recruits subjects, inclusive of regularly visiting relevant wards
- Obtains informed consent
- Obtains medical histories
- Clinical assessments
- Maintains subject files / source documentation
- Completes / ensures accurate completion of all study logs
- Completes / ensures accurate completion of CRFs
- Manages filing and transmission of CRFs
- Schedules subject appointments
- Coordinates subject follow-up
- Resolves data queries
- Develops and maintains site SOPs and other site and quality management documents
- Coordinates quality management activities
- Completes sponsor questionnaires and study preparation materials
- Manages IRB review process
- Manages regulatory files
- Serves as main contact during protocol core team, monitoring and related site visits
- Develops recruitment strategies
- Develops strategies/procedures to track subjects and ensure return for follow-up visits
- Maintains communication and collaboration with relevant hospital clinicians / departments
- Develops study tools, checklists, and logs as needed
- Coordinates financial reporting, invoicing
- Coordinates study supply procurement
- Manages administrative aspects of studies
- Attends INA-RESPOND trainings, meetings, and conference calls
- Serves as main contact with Protocol Core Team and monitoring, working closely to exchange information, coordinate site preparation activities, and support tracking of study progress
Skills /Experience / Other Requirements:
- Medical doctor
- Familiarity with applicable international, US and Indonesian, regulations and guidelines pertaining to clinical research including ICH- E6 Good Clinical Practice Guidelines
- Prior clinical research experience as a study coordinator, investigator, research nurse, clinical research associate/monitor or similar is strongly preferred.
- Ability to coordinate complex systems for research quality control.
- Excellent organizational and time management skills.
- Ability to keep detailed and accurate records.
- Very strong interpersonal skills, flexibility.
- Strong written and verbal communication skills.
- Written and verbal fluency in Bahasa Indonesia and English.
- Fixed-term (one year or more)
To apply, please email your Resume/CV
- to :firstname.lastname@example.org, email@example.com :firstname.lastname@example.org, email@example.com, firstname.lastname@example.orgPlease write “RA AFIRE Application” in the subject line of your email.
Interested parties should respond immediately.Application closing date: 05 December 2014.