Research Study Coordinator I- Infection Disease

Henry Ford Health•Detroit, MI

About The Position

The Research Study Coordinator I is responsible for coordinating and supporting clinical and research studies in compliance with institutional policies, Good Clinical Practice (GCP), and applicable federal regulations. Working under minimal supervision, this role provides technical and operational support to Principal Investigators and research teams while overseeing participant recruitment, study implementation, regulatory compliance, and day-to-day project activities. The Coordinator serves as a key liaison among research participants, investigators, sponsors, regulatory agencies, and clinical teams to ensure study objectives are achieved while maintaining participant safety, data integrity, and compliance with protocol requirements.

Requirements

Bachelor's degree in a scientific discipline, Psychology, Sociology, Anthropology, Public Health, Healthcare Administration, Life Sciences, or a related field.
Research, healthcare, clinical operations, or project coordination experience preferred.
Experience working in clinical research, human subject research, academic research, or healthcare settings is beneficial.

Nice To Haves

Experience coordinating clinical trials or human subjects research studies.
Knowledge of FDA regulations, Good Clinical Practice (GCP), HIPAA, and informed consent requirements.
Experience with participant recruitment, retention, and study coordination.
Familiarity with electronic data capture systems, research databases, and regulatory documentation processes.
Experience interacting with sponsors, investigators, research participants, and regulatory agencies.
Strong organizational, analytical, communication, and project management skills.
Ability to manage multiple priorities while maintaining attention to detail and regulatory compliance.
Demonstrated ability to work effectively both independently and within multidisciplinary teams.

Responsibilities

Reviews, interprets, and maintains a thorough understanding of research protocols, study procedures, timelines, and project requirements.
Utilizes and maintains study-specific databases and tracking systems related to participant recruitment, specimen management, inventory, and study operations.
Organizes and maintains study files, regulatory binders, source documentation, and other essential research records.
Coordinates sponsor visits, site tours, and research-related meetings while demonstrating institutional compliance with research regulations and quality standards.
Participates in investigator oversight meetings and communicates study updates to key stakeholders.
Provides training, guidance, and operational support to research team members as needed.
Assists in the development of study-related training materials, tools, recruitment plans, workflows, and educational resources.
Maintains expertise in assigned research disciplines and stays current on regulatory and industry developments.
Collaborates with sponsors and external stakeholders to clarify protocol requirements and support study execution.
Ensures research activities are conducted in accordance with study protocols, Good Clinical Practice (GCP), institutional policies, and applicable regulations.
Assists with preparation and maintenance of regulatory submissions, continuing reviews, study amendments, and informed consent documentation.
Maintains accurate and complete research records in compliance with regulatory standards.
Documents study activities and data according to established quality assurance procedures and standard operating procedures.
Monitors and reports adverse events, protocol deviations, privacy incidents, and participant safety concerns under the direction of the Principal Investigator.
Maintains regulatory binders and study documentation to support audits, inspections, and compliance reviews.
Coordinates participant recruitment, screening, enrollment, retention, and follow-up activities.
Serves as a primary point of contact for study participants throughout the research lifecycle.
Assists in developing and implementing recruitment and retention strategies to support enrollment goals.
Coordinates recruitment team schedules and study-related participant activities.
Collaborates with clinical staff and research leadership to implement study protocols within clinical and community-based recruitment settings.
Assists with study setup and operational workflows to support successful research implementation.
Supports specimen collection activities and ensures proper documentation and handling of research samples.
Maintains regular communication with study investigators to ensure participant safety and protocol adherence.
Manages and tracks study-related participant incentives and associated documentation.
Interacts professionally and compassionately with diverse participant populations.
Maintains comprehensive knowledge of study protocols, inclusion and exclusion criteria, procedures, timelines, and research objectives.
Communicates protocol requirements and study updates to research team members to ensure consistent implementation.
Supports participant enrollment activities and coordinates research procedures under the supervision of the Principal Investigator.
Provides methodological and technical support to investigators and research teams.
Coordinates activities among clinical departments, laboratories, imaging services, pathology, cardiology, and other study-related service areas.
Acts as an advocate for participants by facilitating timely communication and coordination of research-related testing and results.
Assists with monitoring participant progress, adverse events, and protocol compliance throughout the study.
Reports serious adverse events and safety concerns in accordance with sponsor and regulatory requirements.
Abstracts and enters clinical research data into case report forms and study databases within required timelines.
Serves as a liaison among investigators, sponsors, study teams, and research sites to facilitate communication and issue resolution.
Coordinates sponsor monitoring visits, audits, regulatory inspections, and corrective action plans when necessary.
Maintains accurate, complete, and timely research databases and study records.
Reviews research data for quality, completeness, and protocol compliance.
Identifies and resolves data discrepancies in collaboration with study personnel.
Supports development and maintenance of departmental databases and operational tracking tools.
Trains research staff on database usage, reporting processes, and study management systems.
Prepares reports and study metrics to support project monitoring and operational performance.
Remains current on evolving clinical research regulations, standards, and best practices.