Senior Investigator Support Assistant
Location: Bangalore, India
Department: Global Investigator Support (GIS) / Lab Operations
Employment Type: Full-Time
Position Overview
The Senior Investigator Support Assistant (SISA) serves as a critical operational support resource within the Global Investigator Support (GIS) function, ensuring seamless communication and coordination between investigator sites, sponsors, laboratories, and internal stakeholders involved in clinical trials.
This role is responsible for managing investigator communications, specimen logistics support, query resolution, portal administration, accession hold management, reporting activities, and operational workflow support while maintaining the highest standards of patient safety, regulatory compliance, and service quality.
The ideal candidate possesses strong organizational, communication, and problem-solving skills with the ability to manage multiple priorities in a fast-paced, global clinical research environment.
Key Responsibilities
Investigator Site Support & Communication
Act as a primary support resource for investigator sites and study teams.
Coordinate timely communication with investigator sites via:
Telephone
Investigator Portals
Approved communication platforms
Respond to site inquiries and operational requests.
Escalate complex issues to appropriate Global Coordinators or management teams.
Support implementation of new policies, procedures, and study-related communications.
Operational & Administrative Support
Provide day-to-day administrative support to Global Investigator Support Coordinators.
Maintain and manage shared mailboxes according to established workflows and service standards.
Prepare and distribute operational documents and communications.
Support internal reporting requirements and workflow tracking activities.
Maintain accurate records and documentation within applicable systems.
Specimen Logistics & Shipping Coordination
Prepare airway bills and shipping documentation for investigator sites.
Coordinate shipping requests and specimen transportation activities.
Monitor and resolve delivery-related issues in collaboration with logistics partners and internal departments.
Communicate Specimen Pending Arrival Reports (SPARs) to investigator sites.
Ensure timely resolution of specimen shipment discrepancies.
Investigator & Sponsor Portal Support
Assist investigator sites with:
Portal registration
User account setup
Login and access issues
Technical support requests
Coordinate resolution of portal-related issues with appropriate support teams.
Maintain access records and support documentation.
Query Resolution & Data Management
Investigate and resolve project-related operational inquiries.
Update databases and systems with follow-up information received from investigator sites.
Monitor and address system-generated holds and workflow exceptions.
Escalate unresolved issues to designated coordinators and project stakeholders.
Maintain accurate and timely data entry across operational systems.
Accession Hold Management
Monitor accession hold reports and identify pending issues.
Investigate causes of accession delays and processing exceptions.
Coordinate resolution activities with laboratory and operational teams.
Notify Supervisors and Project Managers of critical delays or escalations.
Ensure timely closure of accession-related issues.
Safety Alerts & Critical Notifications
Support patient safety activities by managing:
Critical laboratory alerts
Panic value notifications
Test cancellation communications
Exclusion flag notifications
Notify investigator sites, sponsors, and affiliates in accordance with study requirements and Statements of Work (SOWs).
Escalate safety concerns immediately according to established procedures.
Compliance & Quality Management
Ensure compliance with:
Standard Operating Procedures (SOPs)
Departmental Guidelines
Quality Standards
Regulatory Requirements
Document service failures, deviations, and operational issues.
Collaborate with global teams to identify root causes and implement corrective actions.
Support audit readiness and quality improvement initiatives.
Reporting & Process Improvement
Generate and maintain operational reports and workflow metrics.
Monitor service levels, turnaround times, and key performance indicators.
Assist management with reporting requests and operational analysis.
Support implementation of process improvements and global operational initiatives.
Contribute to continuous improvement efforts aimed at enhancing efficiency and customer satisfaction.
Documentation & Training Support
Maintain training records and documentation.
Complete assigned SOP reviews and mandatory training requirements within established timelines.
Participate in onboarding, process training, and system enhancement activities.
Support knowledge-sharing initiatives across the team.
Office & Operational Support
Operate and maintain office equipment including:
Printers
Fax Machines
Copiers
Scanning Equipment
Print and distribute:
Laboratory Reports
Data Revisions
Failed Fax Notifications
NPAT Documentation
Support administrative and operational functions as required.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Healthcare Administration
Business Administration
Related Discipline
OR
Equivalent combination of education and relevant work experience.
Preferred Education
Master's Degree in Life Sciences, Clinical Research, Healthcare Management, or related field.
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