Clinical Trial Monitoring Officer
The Institute for HIV Research and Innovation (IHRI) (Formerly PREVENTION, Thai Red Cross AIDS Research Centre) is a leader in research and innovation in the prevention of HIV and other health issues. We are a non-profit organization that is focused on organizational development through effective human resources management and capacity development processes to enable our personnel to work as efficiently as possible. Based on equality and community participation, which drives good public health policy. In addition, IHRI is a regional resource for research, education and training.
The Institute for HIV Research and Innovation (IHRI) stands for the elimination of stigma and discrimination and respect for diversity, to allow individuals to truly demonstrate their full potential, meet challenges, and have opportunities for career advancement and personal development to build a creative society together with us.
Role Overview: The Clinical Trial Monitoring Officer will preparation and execution of clinical HIV and non-HIV research studies. Support to oversee the progress of clinical investigations by conducting site evaluation, initiation, and close out visits. Monitors clinical trials in accordance with Good Clinical Practices and standard operating procedures set by IHRI. Works closely with principal investigators and study team to ensure all monitoring activities are conducted according to study requirements. Supervises a team of Senior Clinical Trial Monitors and delegates tasks to clinical trial team members according to required research studies. Ensures quality of work related to clinical research activities.
Core Accountability & Responsibility:
1. Managing regulatory authority applications and approvals that oversee the research of new and existing drugs.
2. Coordinates and manages the activities of investigator and the investigator's trial staff to ensure compliance with study protocol requirements.
3. Obtain informed consent of the participant or their guardians.
4. Assist with the compilation of required documents for trial activation.
5. Monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis.
6. Evaluates clinical data and coordinates data query resolutions.
7. Conducts clinical research and data monitoring and completes monitoring visit reports.
8. Quality Assurance and Quality Control.
9. Performs other tasks as assigned.
Qualifications and Experience
1. Bachelor’s degree or Master degree in Nursing, Biological Science, Pharmacy, Public Health or other related fields.
2. Minimum of 3 years of experience in monitoring clinical studies, especially HIV/AIDS and other relevant diseases
3. Adequate computer skills.
4. Good knowledge of drug development process, clinical trial monitoring procedures, medical terminology and ICH/GCP guidelines.
5. Research quality assurance and quality control management.
6. Clinical data monitoring and evaluation skills.
7. Communication skills (written and verbal) in Thai and English.
8. Thai citizen
Location: BTS Ratchadamri
Please send your cover letter, CV and expected salary by email to firstname.lastname@example.org. If you need any further information, please contact us via e-mail or phone: 02 252 9958 or visit our website at www.ihri.org Application Deadline: 31 October 2020 Only short-list candidates will be notified.
Contact : email@example.com / 02-2529958 / 061-8689651