Research Study Coordinator I- Center for Individual & Genomic Medicine

Company Description

Henry Ford Health partners with millions of people on their health journey, across Michigan and around the world. We offer a full continuum of services from primary and preventative care to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other health care retail. With former Ascension southeast Michigan and Flint region locations now part of our team, Henry Ford's care is available in 13 hospitals and hundreds of ambulatory care locations. Based in Detroit, Henry Ford is one of the nation's most respected academic medical centers and is leading the Future of Health: Detroit, a $3 billion investment anchored by a reimagined Henry Ford academic healthcare campus.

Job Description

About the Department

Join Henry Ford Medical Group, one of Michigan's largest physician organizations, dedicated to delivering coordinated care across primary and specialty practices throughout the region. Our team thrives on collaborative teamwork, access to leading clinical resources, and the opportunity to build lasting relationships with patients and communities. Be part of a dynamic environment where innovation and patient-centered care are at the forefront of everything we do.

Why Henry Ford Health

At Henry Ford Health, we are relentless advocates for exceptional care for our patients, communities, and each other. We come to do meaningful work and grow our careers, and we stay for the connection, support, and shared pride in making the impossible, possible.

Role Overview

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.

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

What We Offer

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.

Join Our Team

Ready to make a difference? Apply now to become a Research Study Coordinator I at Henry Ford Health!