Clinical Research Coordinator - Women's Health Department

University Health

3d•Onsite

About The Position

We’re looking for a Clinical Research Coordinator to join our team and help bring innovative clinical studies from concept to completion. In this role, you’ll play a key part in the coordination and management of clinical research studies, partnering closely with investigators, patients, sponsors, and internal teams. You’ll use your clinical knowledge, organizational skills, sound judgment, and attention to detail to ensure studies are conducted safely, efficiently, ethically, and in accordance with research protocols, Good Clinical Practice (GCP), federal and state regulations, and institutional requirements. From screening and recruiting participants to coordinating study visits, maintaining regulatory documentation, and supporting study closeout, you’ll help ensure every aspect of the research process runs smoothly. You’ll also serve as an important liaison between investigators, research participants, sponsors, institutional departments, and regulatory bodies, including the Institutional Review Board (IRB) and Privacy Board.

Requirements

Bachelor’s degree in an allied health, medical, or related field.
Clinical Research Coordinator certification through either the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA).
Three years of clinical research experience.
Working knowledge of: Good Clinical Practice (GCP) standards, U.S. Department of Health and Human Services regulations for the protection of human subjects, U.S. Food and Drug Administration (FDA) regulations, International Council for Harmonisation (ICH) guidelines, HIPAA Privacy Rule as it applies to clinical research.
Ability to manage multiple studies, projects, and priorities simultaneously while maintaining strict adherence to study protocols, regulations, and organizational policies.
Strong verbal and written communication skills, with the ability to effectively collaborate with patients, investigators, sponsors, regulatory partners, and multidisciplinary teams.
Strong analytical, organizational, time-management, and project-management skills.
Exceptional attention to detail and the ability to work independently with minimal supervision.
A commitment to research excellence, patient safety, ethical practices, collaboration, and advancing healthcare through clinical research.

Responsibilities

Coordinate clinical studies from initial start-up through study completion, ensuring all activities are conducted according to approved protocols, GCP standards, regulations, and institutional policies.
Manage study screening, participant recruitment, enrollment, scheduling, and study visits while creating a positive and supportive experience for research participants.
Partner with investigators and multidisciplinary teams to plan and implement study requirements and prepare the site for new study initiation.
Serve as a key point of contact and liaison among investigators, participants, sponsors, institutional departments, and regulatory organizations.
Help identify and evaluate opportunities to bring new clinical trials to the organization and support study marketing and participant recruitment efforts.
Help ensure the safety, privacy, and well-being of every research participant throughout the study.
Ensure study-related laboratory testing and other protocol-required procedures are appropriately ordered and completed.
Maintain accurate accountability and documentation for investigational products and test articles.
Protect participant confidentiality and ensure compliance with applicable federal and state privacy requirements, including HIPAA.
Conduct all research activities within an ethical framework and in accordance with applicable regulations, GCP standards, institutional policies, and approved study protocols.
Maintain complete, accurate, and audit-ready study records, including regulatory documents, informed consent and privacy authorization forms, IRB approvals, source documentation, investigational product records, delegation logs, case report forms, and study correspondence.
Collaborate with investigators to prepare and submit research protocols and required documentation to the appropriate IRB and regulatory committees.
Manage ongoing communication with the IRB, including protocol amendments, informed consent updates, safety information, adverse events, protocol deviations, and continuing reviews.
Assist with administrative and regulatory submissions and facilitate the completion of study agreements, including confidentiality agreements and clinical trial agreements.
Stay current on applicable research regulations, guidelines, institutional policies, and industry standards to ensure ongoing compliance.
Partner with investigators and department leadership to manage the financial aspects of clinical trials.
Monitor study revenue and resources to help ensure adequate financial support for study activities and research staffing.
Assist with the development of research protocols, project plans, and business plans.
Contribute to scientific publications, research presentations, and the organization’s annual research reporting.
Participate in the development and continuous improvement of research policies, procedures, and workflows.
Serve as a resource and mentor to fellow research coordinators and research staff.
Provide education, training, and in-service instruction to research team members.
Assist colleagues throughout the organization with research-related questions, processes, and best practices.
Provide supervision and performance support for other research staff when needed.
Promote a culture of collaboration, continuous learning, quality improvement, patient safety, and professional growth.
Provide compassionate, respectful, and age-appropriate service to patients and research participants, recognizing and responding to their physical, psychosocial, educational, and safety needs.
Maintain a welcoming, professional, and helpful demeanor with patients, families, visitors, physicians, colleagues, and all others representing or interacting with the organization.
Champion cultural diversity, inclusion, quality improvement, and safety through everyday interactions and department operations.
Demonstrate professionalism and accountability while representing the organization and its commitment to excellence in patient care and clinical research.
Maintain current knowledge of applicable federal and state statutes, regulations, GCP standards, research guidelines, and institutional requirements.
Comply with the organization’s Code of Conduct, Corporate Compliance Plan, and Compliance Policies and Procedures, including all required training.
Participate in compliance and quality activities as directed by department leadership and the Corporate Compliance Officer.
Pursue ongoing professional development to remain current in clinical research practices, regulations, and industry standards.