SICRES

Role and Responsibilities:

• Control and monitor clinical research to ensure that research activities run smoothly and comply with study research protocols
• Ensures that the clinical research is conducted under the stipulations of the ethical standard, Good Clinical Practices (GCPs), regulatory requirements, and institutional policies and procedures
• To supervises the adherence to SOPs, Good Clinical Practice, and FDA regulations. Also, helps with the development and implementation of clinical processes, procedure, and programs
• To manages subordinate staff in the day-to-day performance of their jobs
• Define subject recruitment strategies and ensure operational feasibility and timely implementation of the set study goals
• Works with team to manage the day-to-day study activities, including problem solving and communication
• Perform other relevant duties as assigned by the supervisor
• Able to perform tasks efficiently and comply with ISO 9001:2015
  
  

Qualifications and Requirements:

• Bachelor’s or higher degree in Pharmacy, Nursing, Science or Health Science-related field
• A minimum of 8 years of experience in monitoring/managing clinical research
• Good knowledge of local regulatory requirements and ICH-GCP
• Good understanding of and interest in clinical research
• Excellent organizational and time management skills, with solid attention to details
• Strong leadership, teamwork, and collaboration skills
• Good presentation, and interpersonal skills
• Strong written and verbal communication skills in Thai and English
• Proficient in the use of Microsoft Office and Microsoft Outlook

Role and Responsibilities

• Perform site selection (if applicable), initiation, monitoring, and close-out visits by the contracted scope of work and good clinical practice.
• Perform Regulatory, Start-up, and Maintenance activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Review, prepare and negotiate site contracts and budgets with sites, if applicable.
• Review, track and follow up the progress, approval, and execution of documents, including contracts, regulatory, ethics ICF, and IP Release documents, in line with project timelines.
• If applicable, may be accountable for supporting the development of project subject recruitment plan on a per-site basis. Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites, and therapeutic areas.
• Provide protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. 
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• Perform other duties as assigned by management
  
  

Qualifications and Requirements

• Bachelor’s Degree in biomedical science or related Science field
• At least two years of experience in clinical research or other relevant experience
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Computer skills including proficiency in the use of Microsoft Word, Excel, and PowerPoint and use of a laptop computer
• Strong written and verbal communication skills, including good command of the English language
• Strong organizational and problem-solving skills
• Effective time management skills
• Ability to establish and maintain effective working relationships with all internal and external partners and stakeholders
• Ability to apply critical/strategic thinking to each opportunity
• Ability to travel domestically and internationally

Contract Type:
Freelance

Qualifications:

• Applicants should provide their writing scores minimum of IELTS writing 5.5 or TOEFL writing 18
• MD applicants may not require English proficiency
• For non-MD applicants with Medical or Sciences Major (3rd year or above), English proficiency is required

Role and Responsibilities:

• Collaborate with management to develop and implement an effective communications strategy based on our target audience
• Initiate and execute both short-term and long-term communication plans, programs, and activities through both offline and online
• Establish and maintain effective relationships with new and existing collaborative partners and the outside
• Accelerating the visibility of SICRES among its partners, government departments, and the general population and seek opportunities to enhance the reputation of SICRES and coordinate publicity events as required
• Write, edit, distribute and maintain the content, including publications, press releases, website, social media accounts, annual reports, newsletters, speeches, and other material that communicates the organization’s activities, projects, and services
• Develop layout and artworks for any assigned projects in a quality and timely manner
• Working closely with the Business Development Officer to undertake worthwhile marketing activity
• Being a point of contact for telephone & email inquiries about SICRES and act as a liaison between the organization, the public, and the media
• Supporting the efforts of research and grant writing and application
• Minute taking and preparing detailed reports on critical meetings and events
• Perform departmental administrative tasks as needed
• Flexible to perform other roles and responsibilities as assigned
• Able to perform tasks efficiently comply with ISO 9001:2015
  
  

Qualifications and Requirements:

• Bachelor’s Degree in the related field
• Professional using of design and publishing software such as InDesign, Photoshop, and Illustrator
• Proficient in Microsoft Office and Microsoft Outlook
• Initiative and creative thinking
• Graphic design working and presentation skills are needed
• Ability to interact positively and professionally at all levels
• Good attention to detail and accuracy. Be able to work at all times during the crisis
• Excellent interpersonal and communication skills (oral and written)
• Good command of written and spoken Thai and English

Role and Responsibilities:

• Coordinates clinical research to ensure that research activities run smoothly and comply with study research protocols.
• Ensures that the clinical research is conducted following the stipulations of the ethical standard, Good Clinical Practices (GCPs), regulatory requirements, and institutional policies and procedures
• Coordinates all components of data collection and patient recruitment for the clinical research
• Maintains adequate inventory of study supplies
• Handling investigational drugs and devices following the sponsor protocol and institutional policies and procedures on Investigational Drug/Device Accountability
• Completes study documentation and maintains study files according to sponsor requirements and institutional policies and procedures, including consent forms, source documentation, case report forms, investigational material accountability forms
• Retains all study records under sponsor requirements and institutional policies and procedures
• Works with investigators to manage the day-to-day study activities, including problem-solving, communication, and protocol management
• Maintains effective and ongoing communication with sponsor, IRBs/IEC, investigator, and research participants during the study
• Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source
• Externally and internally communicates and facilitates monitoring and auditing visits by FDA and sponsors
• Perform other relevant duties as assigned by the project leader
• Able to perform tasks efficiently comply with ISO 9001:2015

Qualifications and Requirements:

• Bachelor’s Degree in Pharmacy, Nursing or Health Science-related courses. (New graduates are welcome)
• A minimum of 4 years of experience in monitoring/managing clinical research
• Good knowledge of local regulatory requirements and ICH-GCP
• Good understanding of and interest in clinical research
• Excellent organizational and time management skills, with solid attention to detail
• Proficient in spoken and written English
• Good verbal and written communication skills, presentation skills, and interpersonal skills
• Proficient in the use of Microsoft Office and Microsoft Outlook
• Willingness to travel for job-related activities if required (less than 10%)

Role and Responsibilities:

• Coordinates clinical research to ensure that research activities run smoothly and comply with study research protocols.
• Ensures that the clinical research is conducted in accordance with the stipulations of the ethical standard, Good Clinical Practices (GCPs), regulatory requirements and institutional policies and procedures.
• Works closely with Principal Investigator (PI) to plan, organize, and perform clinical trial activities.
• Manages a caseload of research patients. Provide patients and their relatives with accurate information and assist them with the informed consent process. This will include discussing the concept of clinical trials and randomization, details of treatment options, investigations, and side effects as well as following up for specific clinical trials.
• Perform other relevant duties as assigned by the project leader.

Qualifications and Requirements:

• Bachelor’s degree in Nursing with current Thai licensure and valid Registered Nurse (RN).
• A minimum of 0-2 years of experience in nursing care practice.
• Good knowledge of local regulatory requirements and ICH-GCP.
• Good understanding of and interest in clinical research.
• Excellent organizational and time management skills, with a strong attention to details.
• Proficient in spoken and written English.
• Good spoken and written communication skills, presentation skills, and interpersonal skills.
• Proficient in the use of MS Office and MS Outlook
• Willingness to travel for job related activities if required (less than 10%)