Research Study Coordinator I

About the Role

As a Research Study Coordinator I, you will play a vital role in coordinating research projects within regulatory compliance guidelines. You will provide technical support to Principal Investigators, oversee recruitment, and manage day-to-day study operations. Your work ensures the smooth execution of research studies, directly impacting patient care and scientific advancement.

Key Responsibilities

Project Coordination

• Reviews, interprets, and maintains knowledge of study protocols, procedures, timelines, and project requirements.
• Utilizes and maintains study-specific databases and tracking systems, including participant recruitment, specimen management, and study supply inventories.
• Organizes and maintains study files, regulatory binders, source documentation, and research records.
• Coordinates research-related site visits, sponsor tours, and study meetings while demonstrating compliance with regulatory and institutional standards.
• Participates in investigator and project oversight meetings and communicates study updates to key stakeholders.
• Provides training, guidance, and operational support to research staff and study team members.
• Assists in developing training materials, study tools, workflow processes, recruitment plans, and participant engagement resources.
• Maintains expertise in assigned research areas and stays current on emerging research practices and regulations.
• Communicates with study sponsors and external partners to clarify protocol requirements and support study execution.

Regulatory Compliance

• Ensures study activities are conducted in accordance with research protocols, Good Clinical Practice (GCP), institutional policies, and federal regulations.
• Assists with the preparation and maintenance of regulatory submissions, study amendments, continuing reviews, and informed consent documents.
• Maintains accurate and complete study records in compliance with regulatory requirements.
• Monitors, documents, and reports adverse events, protocol deviations, participant safety concerns, and privacy incidents under the direction of the Principal Investigator.
• Conducts quality reviews to ensure data integrity, protocol compliance, and accurate study documentation.
• Maintains regulatory binders and study documentation to support audits and inspections.

Participant Recruitment and Study Oversight

• Coordinates participant recruitment, screening, enrollment, retention, and follow-up activities.
• Serves as the primary contact for study participants and provides ongoing communication and support throughout the research process.
• Develops and implements recruitment strategies in collaboration with investigators, clinical staff, and research leadership.
• Coordinates recruitment team schedules and study coverage to support enrollment goals.
• Assesses participant eligibility and supports informed consent activities in accordance with study protocols.
• Assists with specimen collection activities and ensures proper handling, tracking, and documentation of research samples.
• Monitors participant engagement, retention, and study compliance while prioritizing patient safety and participant experience.
• Manages and tracks study-related participant incentives and documentation.

Clinical Research Coordination

• Maintains comprehensive knowledge of research protocols, inclusion and exclusion criteria, study procedures, and study timelines.
• Supports participant enrollment and study implementation under the supervision of the Principal Investigator.
• Provides technical and methodological support to investigators and study teams.
• Coordinates research activities across multiple departments, including clinical, laboratory, radiology, pathology, and other support services.
• Serves as a liaison between investigators, sponsors, regulatory agencies, and research participants.
• Facilitates communication among study stakeholders and ensures timely resolution of study-related issues.
• Reviews and abstracts clinical research data into study databases and case report forms within required timelines.
• Assists with monitoring participant outcomes, adverse events, and protocol adherence.
• Supports study audits, sponsor monitoring visits, regulatory inspections, and corrective action planning.

Data Management and Quality Assurance

• Maintains research databases and study records to ensure complete, accurate, and timely data collection.
• Reviews data quality and resolves discrepancies in collaboration with study personnel.
• Generates reports and tracks study metrics, enrollment performance, and operational outcomes.
• Trains research staff on database functionality, study systems, and data management processes.
• Supports the development and maintenance of departmental databases and operational tracking systems.

Qualifications

Required Qualifications

• Bachelor's degree in a scientific discipline, Psychology, Sociology, Anthropology, Public Health, Healthcare Administration, or a related field.

Strongly Preferred Qualifications

• Experience interacting directly with patients in clinical, research, or healthcare settings.
• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
• Experience maintaining study documentation, source documents, regulatory binders, and case report forms.
• Knowledge of and experience working with human subjects research, including informed consent and research compliance requirements.
• Phlebotomy experience, including blood specimen collection, processing, and handling.

Preferred Qualifications

• Phlebotomy Experience or Certification
• SOCRA or ACRP certification preferred.
• IATA certification preferred.

Additional Information

Join a team where you can grow your career, collaborate with experts, and contribute to mission-driven work. We provide opportunities for continuous learning and professional development in a supportive and innovative environment.