Clinical Trial Coordinator

7 months ago


Thailand Culmen International LLC Full time

Overview:Established in 2004, Culmen International is committed to enhancing international security, strengthening homeland defense, optimizing government operations and providing humanitarian assistance around the world. We provide technical and management expertise, develop innovative technology solutions, and deliver youth care services, logistics, training and language services worldwide. With experience in over 126 countries, Culmen supports our clients to accomplish critical missions in challenging environments.
Roles & Responsibilities:Culmen International is hiring a **Regional Clinical Inspector** to lead the research for bacterial and parasitic disease research. The overall mission is to study and develop countermeasures and products to prevent, detect, and treat infectious parasitic and bacterial diseases, through the execution of research, and clinical operations in Cambodia and the region.
Roles and responsibilities:

- Develop and coordinate activities with Cambodia partners, scientific, public health, and medical communities to support the department research mission.
- Interface with local health care delivery centers (such as local clinics, Provincial Health Office and/or hospitals) to develop operational plans for malaria and other infectious disease clinical research study execution.
- Provide clinical research regulatory support relating (but not limited) to providing regulatory advice to all stakeholders in a clinical study; verifying that all studies meet institutional, local and federal ethical, regulatory and GCP (Good Clinical Practices) requirements.
- Collaborate with the Cambodian Government in developing and executing medical diplomatic missions through research and training.
- Support and conduct surveillance to detect infectious disease threats and strains to inform research project priorities and geographical risk assessments.
- Serve as the main conduit to local, national, and US Institutional Review Boards (IRBs) of similar authorities.
- Support and train other remote clinical research coordinators.
- Implement and execute studies.
- Manage/facilitate study monitoring auditing.
- Performing quality control and initiating standard operating procedure (SOPs) and study-specific procedures
- Maintain custodian of clinical study database and other relevant documents.
- In coordination with regional offices, provide quality assurance and regulatory compliance to the execution of surveillance activities.
- Provide regulatory and quality assurance support, in compliance with USG and local policies and regulations, to clinical research studies.
- Coordinate timely delivery of all reports.
- Coordinate with key corporate support offices to align efforts for program success.
- Track and review contract deliverables.

Basic Qualifications:

- Medical Degree or equivalent
- 10 years of experience involved or leading the executions of clinical trials in region
- Fluent in both Khmer and English
- Ability to pass background checks and receive authorization to work in Cambodia.
- Active/Unrestricted License to practice medicine in Cambodia
- Exceptional organizational and communication skills
- Travel will be required to support the development and execution of ongoing and new departmental research protocols

Top Tier Benefits Package:

- Exceptional Medical/Dental/Vision coverage with 100% of the premiums paid by the company for all employees and their eligible dependents
- 401k - Vested immediately and 4% match
- Life insurance and disability paid by the company
- AFLAC Available
- Tuition Assistance
- 12 Paid Holidays

At Culmen International we are committed to creating, promoting, and sustaining a culture of diversity, equity, and inclusion. Our commitment to these values is unwavering across all our work around the world. We include and celebrate employees of diverse races, genders, religions, sexual orientations, ethnicities, nationalities, socioeconomic statuses, languages, (dis)abilities, ages, and religious commitments. These differences drive innovative solutions to meet the needs of our employees and clients. Culmen is an equal opportunity employer.

**Job Type**: Contract



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