Research Study Assistant II- Gastro Procedure - Main

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 your contributions directly impact the health and well-being of those we serve. 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. General Summary Under limited supervision, the Research Study Assistant II supports the coordination and execution of clinical and research studies in compliance with institutional policies, regulatory requirements, and applicable federal regulations. This role serves as a key resource for study operations, participant engagement, regulatory compliance, and data management. The Research Study Assistant II works closely with principal investigators, study teams, clinical staff, sponsors, and research participants to ensure studies are conducted accurately, efficiently, and safely. Direct interaction with research participants is a core responsibility of this position. Research Operations & Regulatory Compliance Supports the implementation and conduct of research studies in accordance with study protocols, institutional policies, Good Clinical Practice (GCP), and applicable federal regulations. Maintains accurate and complete study records, regulatory documentation, and research data. Assists with monitoring, documenting, and reporting adverse events, protocol deviations, and participant safety concerns under the direction of the Principal Investigator (PI) or project leadership. Ensures research activities comply with established quality standards and standard operating procedures. Participates in audit preparation and regulatory reviews as needed. Participant Recruitment & Engagement Assists with the recruitment, screening, enrollment, and retention of research participants. Conducts participant outreach and coordinates study-related communications throughout the research lifecycle. Evaluates participant eligibility and supports the informed consent process according to protocol requirements. Schedules study visits, procedures, and follow-up activities while maintaining compliance with study timelines. Serves as a point of contact for participants and responds to study-related questions and concerns. Demonstrates empathy, professionalism, and cultural sensitivity when interacting with diverse patient populations. Clinical Research Support Completes and maintains study-related documentation, surveys, case report forms, and source documents. Collects, processes, and tracks biological specimens such as blood, urine, and other research samples according to protocol requirements. Assists investigators and study teams with study implementation and participant monitoring. Supports collection, abstraction, and entry of clinical and research data into study databases and electronic data capture systems. Coordinates with clinical departments, laboratories, and research teams to facilitate study activities and ensure timely completion of project deliverables. Project Coordination & Administration Organizes and maintains study files, regulatory binders, participant records, and study materials. Utilizes study-specific databases and tracking systems to monitor participant activity, specimen management, and study progress. Assists with investigator meetings, sponsor communications, and project-related administrative activities. Supports training and onboarding of new research staff on study procedures and research operations. Collaborates with cross-functional teams to ensure effective study execution and compliance with protocol requirements. Data Management & Quality Assurance Maintains accurate research databases and study records. Reviews data for completeness and quality, identifying and resolving discrepancies when appropriate. Assists with generation of reports and tracking metrics related to study performance and participant enrollment. Remains current on research regulations, industry standards, and best practices in clinical research. Qualifications Option 1 High School Diploma or G.E.D. Three (3) years of professional work experience, including at least two (2) years of research and/or healthcare experience. Option 2 Associate's Degree in a healthcare, science, research, or related field. One (1) year of research and/or healthcare experience. Preferred Qualifications Experience coordinating clinical or human subject research studies. Knowledge of research regulations, GCP, HIPAA, and informed consent requirements. Experience collecting and processing biological specimens. Familiarity with electronic data capture (EDC) systems and research databases. Healthcare, hospital, emergency department, or academic research experience. Strong organizational, communication, and problem-solving skills. Ability to manage multiple priorities while maintaining a high level of accuracy and attention to detail. Experience working collaboratively with multidisciplinary teams and diverse patient populations. Additional Information 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 in a supportive and innovative environment. #J-18808-Ljbffr Henry Ford Health Care