Job Description

About the Role:
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 the regulatory documents and prepare study files for inspections and audits.

• Serves as liaison between government leads and collaborators, sponsor, auditors, and ethical review committee.

• Prepares study documents that serve as source documents for the study.

• Screens subjects for eligibility to participate in research protocols, enroll subjects and obtain 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, SOP, SSPs, Good Clinical Practice (GCP) guidelines, sponsor guidelines and other regulatory requirements as applicable.

• Supervise 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;

• Comply with quality assurance/quality control guidance from the Department's Quality Control Unit and authorized internal/external auditors.

• Assists Clinical Investigators in performing study and other procedures as required.

• Coordinate and support the development of the technology solutions and mapping.

• Assists database management staff in any computer related concerns;

• Ensure quality data entry so as to perform accurate statistical analysis for data distribution and publication;

• Prepare periodic study reports and presentations as required.

• Coordinates the procurement, acquisition, shipment and distribution of supplies and equipment needed on-site

Required Qualifications:

• Bachelor's degree in a relevant field such as clinical research administration, nursing, public health or biology.
• Certified Clinical Research Coordinator
• Fluent in English.

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 our clients to accomplish critical missions in challenging environments.
To learn more about Culmen International, please visit www.culmen.com
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.

Skills Required