Job Title
Research Study Assistant II
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.
About the Department
Join the 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 group that is committed to excellence in healthcare and making a meaningful impact on the lives of those we serve.
Position Summary
Under limited supervision, supports the coordination and conduct of research studies in accordance with study protocols, Good Clinical Practice (GCP), institutional policies, and applicable federal regulations. Assists with participant recruitment, study implementation, data collection, regulatory compliance, and day-to-day research operations. Works closely with investigators, clinical staff, study participants, and research teams to ensure studies are conducted safely, accurately, and efficiently. Maintains regular contact with study participants and contributes to the successful execution of research projects.
Regulatory Compliance & Documentation
- Maintains an understanding of research protocols, regulatory requirements, and study procedures to ensure compliance and data accuracy.
- Documents research activities, participant interactions, and study data according to established policies, procedures, and quality standards.
- Assists with monitoring, documenting, and reporting adverse events, protocol deviations, and privacy or safety incidents under investigator supervision.
- Ensures study records and regulatory documentation are complete, accurate, and audit-ready.
Participant Recruitment & Retention
- Assists with recruitment, screening, enrollment, and retention of research participants.
- Coordinates participant interactions throughout the study lifecycle, including scheduling visits, obtaining informed consent, collecting data, and maintaining participant engagement.
- Supports implementation of study protocols within clinical and research settings.
- Assists with recruitment outreach and participant tracking activities to support enrollment goals.
- Determines participant eligibility according to protocol requirements and ensures appropriate consent documentation is obtained.
Clinical Research Operations
- Completes study-related documents, surveys, questionnaires, and case report forms in accordance with protocol requirements.
- Collects, processes, and manages biological and environmental specimens, including blood, urine, and other study-required samples.
- Collaborates with investigators and research staff to ensure participant safety and adherence to study procedures.
- May serve as a point of contact for research participants and study-related inquiries.
Project Coordination
- Maintains study files, regulatory binders, source documentation, and project records.
- Utilizes study-specific databases and tracking systems to manage participant information, specimens, supplies, and study activities.
- Participates in investigator and study team meetings.
- Assists with onboarding and training of new research staff on study procedures and protocols.
Research Support
- Develops and maintains knowledge of study protocols, timelines, inclusion/exclusion criteria, and research procedures.
- Supports participant enrollment activities under Principal Investigator supervision.
- Provides operational and technical support to investigators and research teams.
- Coordinates activities with clinical departments and ancillary services to support study requirements.
- Assists with data abstraction, entry, and quality review to ensure timely and accurate reporting.
- Serves as a liaison between research staff, investigators, and study stakeholders as appropriate.
- Supports audit preparation and regulatory inspections.
- Maintains current knowledge of clinical research regulations, policies, and best practices.
Education
Option 1
- High School Diploma or GED.
- Three (3) years of work experience, including at least two (2) years of research and/or healthcare experience.
Option 2
- Associate degree in a research, healthcare, science, or related field.
- One (1) year of research and/or healthcare experience.
Preferred Qualifications
- Experience supporting clinical, translational, public health, or observational research studies.
- Knowledge of Good Clinical Practice (GCP), human subject protections, and research compliance requirements.
- Experience with participant recruitment, informed consent, specimen collection, and research data management.
- Strong organizational, communication, and customer service skills.
- Ability to work effectively with diverse patient populations, investigators, and interdisciplinary teams.
- Experience using electronic data capture systems, research databases, and Microsoft Office applications.
- Experience with regulatory compliance in research settings.
- Strong organizational and communication skills.
****MUST be able to work Wednesdays****
What We Offer
Join a team where you can grow your career, collaborate with dedicated professionals, and engage in mission-driven work that makes a difference. We provide opportunities for continuous learning and development, empowering you to reach your full potential in a supportive and innovative environment.
Join Our Team
Ready to make an impact? Apply now and be part of our mission to advance healthcare through research and exceptional care.
