Job Description

The Regulatory and Monitoring Specialist will manage regulatory and monitoring activities for the Indonesian Research Partnership on Infectious Diseases (INA-RESPOND) in Jakarta, in coordination with RSPI Sulianti Saroso and the Health Research and Development Agency, Ministry of Health, Indonesia.

This position plays a key role in managing regulatory activities and monitoring study conduct to ensure adherence to protocols, Good Clinical Practice (GCP) guidelines, and applicable regulations. In addition, the role also works closely with the Site Management team and Clinical Research Unit (CRU) Specialist to support smooth and compliant research operations.

DUTIES AND RESPONSIBILITIES: 

Regulatory 

• Maintain up-to-date knowledge of applicable regulatory requirements, guidelines, and procedural changes.
• Coordinate the development and maintenance of site- and country-specific regulatory profiles.
• Liaise with government agencies, regulatory authorities, and ethics committees as needed.
• Oversee regulatory documentation processes, including review, tracking, and archiving.
• Ensure study documents such as site-specific Informed Consent Forms (ICFs), Investigator Agreements, and related documents meet regulatory standards.
• Manage and track all INA-R Standard Operating Procedures (SOPs).
• Responsible on the regulatory submission and reporting to the National Agency of Drug and Food Control (BPOM).
• Responsible for clinical trial registration on ClinicalTrial.gov
• Participate in the preparation of study documents, Trial Master File (TMF), and Site Regulatory Binder (SRB).
• Support the preparation of Material Transfer Agreements (MTA), and other regulatory reports.

Training

• Plan, coordinate, and conduct training programs for clinical research site staff in areas such as regulatory affairs, and study compliance.
• Develop and adapt training materials, and curricula to meet study-specific and site-specific needs.
• Provide training to site staff to ensure compliance with regulatory and institutional requirements.

Monitoring 

• Develop study-specific monitoring plans and related document.
• Conduct Site Initiation Visits (SIVs), Site Monitoring Visits (SMVs), and Close-Out Visits (COVs) in accordance with study timelines and guidelines.
• Participate in Site Assessment Visits (SAVs) to evaluate site readiness for study initiation.
• Review essential documents to ensure compliance with study protocols and applicable regulations.
• Monitor study conduct, ensuring accurate and complete data collection in Case Report Forms (CRFs) or databases.
• Review adverse event (AE) and serious adverse event (SAE) reports for compliance with protocols, regulations, and guidelines.
• Complete monitoring reports and follow-up correspondence within required timeline.
• Review investigator site files for compliance with regulatory and sponsor requirements.
• Mentor Clinical Research Associate (CRA) trainees in monitoring practices, protocol compliance, and trial documentation.
• Keep current with ICH/GCP guidelines, relevant SOPs, and clinical developments in assigned therapeutic areas.
• Assist in the development of study-specific protocols, manual of procedures, team training, materials, and SOP reviews.

Conflict and Problem Resolution 

• Proactively identify differing interests and priorities among stakeholders, build productive coalition, propose workable solutions, and operationalize them through the approved quality gates.
• Robust mental endurance, and strong focus on problem resolution.

Collaboration and Representation

• Represent the project and INA-RESPOND Secretariat professionally in all communications with collaborators.
• Work closely with internal and external partners to achieve project objectives.

Travel Requirement

• Ability to travel, averaging 50%–75% annually.

Required Skills

• Ability to manage a high-volume workload and multiple projects with shifting priorities.
• Strong technical expertise in clinical research monitoring and development.
• Proficiency in project planning, organization, and problem anticipation/identification.
• Exceptional interpersonal, verbal, and written communication skills.
• Excellent decision-making skills, with the ability to determine when to consult or inform others.
• Ability to serve as a spokesperson for the project/Secretariat, considering the impact of communications and decisions.
• Fluency in Bahasa Indonesia and English, both written and spoken.

Required Experience

• Bachelor’s degree in health science, pharmacology, or related life sciences field; Master’s degree or equivalent preferred.
• Over 10 years of professional experience in clinical research.
• Extensive experience in clinical trial initiation, monitoring, and site close-out activities.
• Member of the Association of Clinical Research Professionals (ACRP) or equivalent professional organization is preferred.
• Strong knowledge of regulatory affairs, GCP, ICH guidelines, and applicable local/national regulations.
• Excellent organizational skills with strong attention to detail.
• Proven ability to work independently and as part of a team, with high professional integrity.
• Prior experience with U.S. government-funded clinical research projects strongly preferred.