Current Vacancies :

Site Specialist (3), Clinical Research Associate (3), Data Manager (2), Scientific Coordinator (1)

please see below

How to Apply

  1. Please review the following list for the available positions.
  2. Click on the position title to proceed to our online form.
  3. Choose the desired position from the drop down menu and proceed to the available form. Please type, do not cut and paste
  4. Submit your resume and or a CV in PDF format.
  5. Submit your current picture in the format of .jpg, .gif, .png, or .bmp with the size no more than 200kb.
  6. Submit your cover letter addressing each selection criterion detailed in the position description with specific and comprehensive information supporting each item. (PDF format)
  7. Ensure you have addressed all the questions in the provided form.
  8. Click on SUBMIT to finalize the submission.
  9. Each applicant can apply for more than one position.

 

Should you require further assistances or if you have any questions, contact us at work.with@ptghrsys.com and our staff will respond to your inquiry based on the order in which it was received.

 

PT Ganesha Aggies Jaya is inviting professionals to fill in the following positions:

     
1. Site Specialist ( 3 )  
 

Job Description
Manage and provide a range of clinical research support activities for the Indonesian Research Partnership on Infectious Diseases (INA-RESPOND) in Jakarta, Indonesia (managed by the National Institute of Health Research and Development, Ministry of Health, Indonesia. Candidate must be comfortable working in a fast-paced environment and must be fluent in Bahasa Indonesia and English.


Duties and Responsibilites:
Key duties and responsibilities may include, but are not limited to, the following:

Site Liaison: Serve as the liaison between the INA-RESPOND Secretariat 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 Evaluation: 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 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.


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 staff, clients and collaborators: Serve as a representative of the project and the INA-RESPOND Secretariat, communicating professionally and effectively with the client and all collaborators.
Additional duties as assigned.


Required Skills

  1. Competently manage a very heavy workload, and multiple projects with competing priorities, switching priorities quickly as needs change.
  2. Demonstrate a very high level of technical skill and expertise as pertains to clinical research site support and development.
  3. Demonstrate high proficiency in project planning and organization and proactively anticipate and identify complex issues and problems.
  4. Demonstrate exceptional interpersonal skills and written and verbal communication abilities.
  5. Demonstrate excellent decision-making abilities with competency in making decisions and resolving problems that could have an impact on the Project and/or Secretariat.
  6. Recognize which decisions may have a consequential effect on the Project and/or Secretariat and make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate.
  7. Act as the spokesperson for the Project/Secretariat and consider the implications of input/decisions, ensuring they are communicated appropriately.

Required Experience

  1. A baccalaureate degree from an accredited college or university.  A master degree or equivalent is preferred.
  2. Relevant experience or coursework in public health, biomedical research or other related field.
  3. A minimum of 3 years of increasingly responsible, broad and diversified professional management experience relevant to implementing clinical research or biomedical training programs.
  4. The ability to competently and independently manage all of the above Duties and Responsibilities with minimal guidance and supervision.
  5. Fluent in Bahasa Indonesia and English, both written and spoken.
  6. Previous experience working with United States government funded clinical research projects strongly preferred. 

 

 
 
 

2.

Clinical Research Associate ( 3 )

 

Job Description                                                                                         
Responsible for performing and coordinating all monitoring strategies for clinical research studies for the Indonesia Research Partnership on Infectious Diseases (INA-RESPOND) in Jakarta, Indonesia (managed by the National Institute of Health Research and Development, Ministry of Health, Indonesia). Conducts site qualification (SQV), site initiation (SIV), site monitoring (SMV) and site close-out visits (SCV) to determine protocol and regulatory compliance. Assures compliance with GCP, ICH, and SOPs set forth by NIAID. Exercises delegated training and supervisory responsibility for CRAs assigned to a specific project.

Duties and Responsibilities:

  • Monitors activities at clinical study sites by conducting SQVs, SIVs, SMVs, and SCVs.
  • Oversees and participates in identifying and recruiting physicians and study sites, verifying qualifications and capabilities to successfully manage and conduct clinical research.
  • Maintains a professional working relationship with all clients, investigators and clinical study sites. 
  • Reviews and approves all essential documents required for implementing, monitoring and evaluating clinical research at assigned sites, per established guidelines. 
  • Monitors compliance with the established protocol, applicable Federal regulations and Institutional Review Board (IRB) requirements.
  • Monitors the progress of clinical trials by verifying the accurate and complete collection/ recording of data on case report forms or database, without supervision.
  • Reviews AE/SAE reporting for compliance with the protocol, national and local regulations and established guidelines.
  • Completion of comprehensive monitoring reports and related correspondence in a timely manner following each monitoring visit, with no errors/edits needed.
  • Reviews and investigator study files to ensure compliance with all applicable regulatory and client requirements.
  • Provides mentoring for CRA trainees in the field. Able to demonstrate the CRA’s role in preparing, monitoring, and reporting results of clinical trials.
  • Keeps abreast of ICH/GCP guidelines, SOPs related to clinical monitoring and current clinical developments in assigned therapeutic areas, independently.
  • Provides project management assistance as delegated, including monitoring report review, assisting in the design of protocol specific manuals and documents and team training
  • Assists with development and review of clinical research site SOPs.
  • Assists in the development of clinical research site staff trainings.
  • Perform other duties as assigned.
  • Ability to travel an annual average of 50% - 75%.

Qualifications:
Education and/or Experience:

  • BS/BA in a life sciences program or field; nursing degree preferred, but not required
  • Minimum two years as a clinical monitor, with documented experience in performing SQV/SIV/SMV/SCVs independently without supervision

Knowledge/Skills/Other Requirements

  • Written and verbal fluency in English and Bahasa Indonesia
  • Strong initiative and ability to work without supervision
  • Strong organizational skills with keen attention to detail
  • Excellent communication skills (written and verbal) with the ability to communicate effectively with clinical site staff
  • Team player with a strong customer focus and excellent interpersonal skills
  • Able to effectively manage multiple priorities within assigned tasks
  • Comprehensive understanding of ICH/GCP guidelines, United States and Indonesian clinical research regulations, medical terminology and clinical research processes
  • Demonstrated ability to mentor and train other monitors in a positive and effective manner
  • Understands the relevance, importance, and inter-relationship of other departments to the success of the clinical research including data management, biostatistics, and regulatory-quality assurance
  • Excellent computer skills and ability to learn and become proficient with appropriate software; working knowledge of Word, Excel, and PowerPoint.
  • Ability to utilize problem-solving techniques applicable to constantly changing environment
  • Prior experience in a Contract Research Organization (CRO) is preferred
  • Prior experience working for a United States government-funded research program is preferred

 

 
 
 
3.
Data Manager ( 2 )  

Job Description
Provides a range of data management activities for the Indonesian Research Partnership on Infectious Diseases (INA-RESPOND) in Jakarta, Indonesia (managed by the National Institute of Health Research and Development, Ministry of Health, Indonesia).

Primarally, the position involves setting up, modifying and programming Clinical Research databases, reports and listings. However, the position also involves providing ongoing support and backup to the Lead Data Manager. The 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:

  • Provides ongoing support and backup for the Lead Data Manager.
  • Provides performance reports to the INA-RESPOND Chairman on an ongoing basis.
  • Setup, modify and program Clinical Research databases, such as OpenClinica and other software.
  • Responsible for Case Report Form (CRF), electronic and/or paper,design, development, and maintenance.
  • Provides technical input on data management for protocol, manual of procedures, and other Data Management-related documents.
  • Assists with development of Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
  • Writes programs for database edit checks, Data Management reports, data listings, and other requirements.
  • Prepares invoicing reports, based on study objective specifications.
  • Assists in reconciling AE/SAE data in Safety database and/or other Data Management database.
  • Coordinates Quality Control (QC) / Quality Assurance (QA) tesing, including data entry screen testing, database testing and edit check testing.
  • Prepares, and provides Clinical Data Management training for research sites and INA-RESPOND staff.
  • Develops, generates and manages data queries, reports, and other data related activities.
  • Communicates with site(s) regarding the data query or other data management issues.
  • Anticipates and identifies potential problems and propose preventive measures and solutions.
  • Serves as a representative of the project and Secretariat, communicating professionally and effectively with the clients and all collaborators.
  • Because the work is collaborative in nature, regular group meetings and some travel may be required.
  • Assists with coordinating the archiving of study databases and related documents.

 

Required Qualifications, Skills and Experience

  • A bachelor’s degree or equivalent tertiary qualification from an accredited institution.
  • A minimum of 5 years experience working in a Clinical Research Data Management environment.
  • Programmer skills and experience is required.
  • OpenClinica, Datafax, R-programming, Java, Oracle post-gres and SAS programming skills are advantageous.
  • Demonstrates a very high level of technical skill and expertise as pertains to clinical research and development.
  • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Demonstrates high proficiency in project planning and organization and proactively anticipate and identify complex issues and problems.
  • Demonstrates good interpersonal skills and communication abilities.
  • Demonstrates good decision-making abilities .
  • Experience providing training and developing training materials.

 

 
 
 

4.

Scientific Coordinator ( 1 )  
 

Job Description
A managerial position within INA-RESPOND, this position will assure that the research conducted will be in full compliance of all medical research regulations through a well-documented and updated research protocol, of high scientific standard, and contributes to the advancement of existing body of knowledge on the subject, and contribute to the Indonesian medical advancement.

Duties and Responsibilities:
Primary tasks is to coordinate Network activities to support international collaborative clinical research activity on emerging infectious diseases.
 Ensures effective communication and productive relationships with hospi-tals, the NIHRD, the Indonesian Directorate General of Disease Control & Environmental Health, Centers for Disease Control (CDC), NIAID, Leidos Biomed, and other institutions. The high-level task outline of this posi-tion includes the list below.

  • Works with the NSC to determine and manage the scientific direction of the Network.

  • Ensures appropriate implementation of the Network's scientific agenda and timely protocol develop-ment, implementation, analysis and publication.

  • Coordinates the activities of the scientific group within the Secretariat to ensure adherence to approved timelines for site readiness and implementation of studies conducted through the Network.

  • Assists in the development of protocols, procedure manuals, and other documents.

  • Supports and facilitates the scientific/protocol activities of the Network and ensures adherence to the International Conference on Harmonization’s Good Clinical Practice (ICH GCP).

  • Coordinates the analysis of study findings

  • Prepares for domestic/international scientific meetings.

  • Contributes to manuscript development for publication of study results.