Research Study Coordinator I- Dermatology

Henry Ford Health•Detroit, MI

About The Position

Under minimal supervision, the Research Study Coordinator I supports the planning, coordination, and execution of clinical and research studies in accordance with federal regulations, institutional policies, Good Clinical Practice (GCP), and study-specific protocols. This position provides operational, regulatory, and participant-facing support to Principal Investigators and research teams to ensure the successful conduct of research projects. Responsibilities include coordinating study activities, supporting participant recruitment and retention, maintaining regulatory compliance, managing study documentation, and serving as a key liaison among investigators, participants, sponsors, and collaborating departments. Direct interaction with prospective and enrolled research participants is a core component of this role.

Requirements

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

Nice To Haves

Society of Clinical Research Associates (SOCRA) Certification preferred.
Association of Clinical Research Professionals (ACRP) Certification preferred.
International Air Transport Association (IATA) Certification preferred

Responsibilities

Review, understand, and implement study protocols, procedures, timelines, and requirements.
Utilize study-specific systems and databases to track recruitment, participant activities, specimens, supplies, and study metrics.
Coordinate study operations and facilitate site visits, tours, and sponsor interactions as needed.
Establish and maintain study documentation, including regulatory binders, source documents, and study files.
Participate in investigator meetings and project planning activities.
Assist in training research team members on study procedures, protocol requirements, and research-related processes.
Develop and maintain knowledge in assigned clinical and research focus areas.
Support the development of study materials, training resources, recruitment tools, and operational documents.
Collaborate with sponsors and stakeholders to obtain clarification and ensure successful execution of study objectives.
Ensure study activities are conducted in compliance with research protocols, institutional policies, federal regulations, and ethical standards.
Assist in preparing regulatory submissions and study-related documentation.
Contribute to the development and maintenance of informed consent documents and research materials.
Maintain accurate study records and documentation in accordance with standard operating procedures and quality standards.
Document, monitor, and report adverse events, protocol deviations, privacy concerns, and safety incidents under the guidance of the Principal Investigator and study leadership.
Support maintenance of regulatory files and audit readiness.
Assist with recruitment, screening, enrollment, and retention of research participants.
Serve as a primary point of contact for study participants throughout the research lifecycle.
Coordinate participant scheduling, study visits, follow-up activities, and engagement efforts.
Implement recruitment strategies and outreach initiatives in collaboration with investigators and clinical partners.
Coordinate recruitment activities and assist with management of recruitment team schedules.
Support specimen collection activities and participant education regarding study procedures.
Track and manage participant incentives and study-related reimbursements when applicable.
Develop a thorough understanding of study objectives, eligibility criteria, timelines, and procedures.
Communicate protocol requirements and study updates to research team members and collaborators.
Support participant enrollment and coordinate study activities under investigator supervision.
Provide technical and operational support to Principal Investigators and research teams.
Collaborate with clinical departments to coordinate collection and submission of research-related materials, including laboratory, pathology, radiology, and other clinical data.
Advocate for participants by facilitating timely communication and coordination of research-related services.
Assist with the assessment, documentation, and reporting of study outcomes, adverse events, and participant status.
Complete case report forms and study documentation within required timelines.
Maintain communication between sponsors, investigators, and study teams to ensure successful study execution.
Coordinate sponsor, regulatory, and internal audits and support corrective action planning when needed.
Maintain and update research databases and departmental tracking systems.
Provide training and support to research staff regarding database functions and study processes.
Stay current on evolving research regulations, industry standards, and best practices in clinical research.