Research Study Assistant II- Gastro Procedure - Main

Henry Ford Health•Detroit, MI

7d•Onsite

About The Position

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.

Requirements

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.
Associate's Degree in a healthcare, science, research, or related field.
One (1) year of research and/or healthcare experience.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.