Research Study Coordinator I- Center for Individual & Genomic Medicine

Henry Ford Health•Detroit, MI

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.