Senior Clinical Research Coordinator

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Culmen International is hiring a qualified Senior Clinical Research Coordinator in Malaysia to provide scientific and technical services to an international Department of Defense medical contract. The objective of this contract is to provide clinical site management and in-country clinical research operations and scientific laboratory support for surveillance, epidemiology, and intervention studies, sample collection, and laboratory testing in field sites located across Southeast Asia. This effort is a cooperative and collaborative project involving committed partner countries to include the United States.

What You’ll Do In Your New Role

• Assists Clinical Investigators in planning and execution of research studies.
• Manages regulatory documents and prepares study files for inspections and audits.
• Serves as liaison between government leads, collaborators, sponsors, auditors, and ethical review committees.
• Prepares study documents that serve as source documents for the study.
• Screens subjects for eligibility to participate in research protocols, enrolls subjects, and obtains informed consent.
• Assists Clinical Investigators in performing study and other procedures as required.
• Schedules and performs follow‑up visits with study subjects.
• Checks and reviews data for any discrepancies recorded on Case Report Forms and electronic CRFs.
• Ensures that studies are conducted in accordance with approved protocols, institutional regulatory requirements, SOPs, SSPs, Good Clinical Practice (GCP) guidelines, sponsor guidelines and other regulatory requirements as applicable.
• Supervises the development of Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs) to standardize the approach to the conduct of the study by collaborative study personnel.
• Complies with quality assurance / quality control guidance from the Department’s Quality Control Unit and authorized internal / external auditors.
• Coordinates and supports the development of the technology solutions and mapping.
• Assists database management staff with any computer-related concerns.
• Ensures quality data entry to enable accurate statistical analysis for data distribution and publication.
• Prepares periodic study reports and presentations as required.
• Coordinates the procurement, acquisition, shipment and distribution of supplies and equipment needed on site.

Required Qualifications

About The Company

Culmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports its clients to accomplish critical missions in challenging environments.

At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants. Our commitment to these principles is unwavering across all our operations worldwide.

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