Clinical Research Operations Coordinator

The Clinical Research Operations Coordinator will manage hands-on clinical sample collection, processing, and logistics within BIIEs research partnerships with hospitals and research centers in low
- and middle-income countries (LMICs). The Clinical Research Operations Coordinator will be an integral part of the BIIE Clinical Core Facility, working closely with the BIIE Faculty Labs and Flagship Programs.
This operational role focuses on implementing standardized SOPs, maintaining sample integrity and chain of custody, and coordinating directly with clinical teams, laboratory staff, and logistics partners. The specialist will ensure strict protocol compliance, quality control, data privacy, and regulatory adherence while troubleshooting operational challenges and maintaining international standards for sample handling.
Tasks
Sample Operations & SOP Management
- Coordinate sample collection activities according to established protocols and SOPs
- Implement and enforce standardized procedures for collection, processing, storage, and transport of clinical samples
- Conduct training sessions on SOP adherence and monitor compliance through site visits
- Oversee sample processing, quality control measures, and cold chain management
- Document deviations and implement corrective actions as needed

Logistics & Documentation
- Maintain chain of custody documentation and track shipments
- Manage sample inventory, labeling, and database entry
- Prepare operational reports on collection metrics and compliance
- Maintain regulatory files and study documentation

Site Coordination & Support
- Serve as primary operational contact for clinical sites on sample activities
- Conduct regular site visits for monitoring and hands-on support
- Coordinate equipment procurement, maintenance, and supply management
- Facilitate communication between sites, laboratories, and coordination teams
- Resolve operational challenges and implement process improvements

Regulatory Compliance & Agreements
- Ensure sample activities comply with applicable regulatory requirements including GDPR standards
- Coordinate Material Transfer Agreements (MTAs) and Data Transfer Agreements to ensure compliance with international regulations
- Manage agreement documentation and ensure proper execution of transfer protocols

**Requirements**:
Required Qualifications
Education & Experience
- Bachelor's degree in life sciences, medical technology, nursing, or related field
- Minimum 3 years hands-on experience in clinical sample collection/processing or laboratory operations
- 2+ years experience with clinical research protocols and SOPs
- Experience in healthcare or research settings

Technical Skills
- Knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and General Data Protection Regulation (GDPR) guidelines
- Understanding of Material Transfer Agreements (MTAs) and Data Transfer Agreements for international collaborations
- Understanding of sample collection techniques, processing, and storage requirements
- Familiarity with regulatory requirements for clinical samples, biological specimens, and cross-border data transfers

Skills and attributes
- Exceptional attention to detail and accuracy in documentation
- Strong organizational and time management skills
- Excellent communication skills in English (additional languages preferred)
- Cross-cultural communication skills
- Ability to work independently and manage multiple concurrent activities
- Proactiveness and problem-solving in a dynamic environment
- Willingness to travel internationally (20-30% of time)

Preferred Qualifications
- Clinical Research Coordinator certification (CCRP, CCRC)
- Experience with specific sample types (blood, tissue, etc.) and biobanking
- Background in immunology, oncology, or infectious disease research
- Experience living/working in LMIC settings
- Knowledge of international shipping regulations for biological specimens

This position offers the opportunity to directly impact global health research by ensuring the highest quality standards in clinical sample coordination while advancing medical research in underserved communities.