PRN Research Coordinator - Emergency Medicine

University Health

46d•Onsite

About The Position

As a Clinical Research Coordinator I, you’ll play an important role in bringing clinical research studies to life—from study start-up and participant recruitment through study completion. Working alongside research investigators and collaborating with patients, sponsors, Institutional Review Boards (IRBs), and teams across the organization, you’ll help ensure clinical trials are conducted safely, ethically, accurately, and in accordance with applicable regulations and Good Clinical Practice standards. This is an excellent opportunity for a detail-oriented healthcare professional who enjoys coordinating multiple priorities, working independently, and making a meaningful contribution to clinical research.

Requirements

Bachelor’s degree in an allied health, medical, or related field.
Ability to manage multiple projects and priorities while maintaining strict adherence to research protocols, regulations, and organizational policies.
Strong verbal and written communication skills.
Demonstrated analytical skills and exceptional attention to detail.
Ability to work independently with minimal supervision.
Strong organizational, time management, and project management skills.
Intermediate computer skills and the ability to effectively use technology to manage research activities and documentation.

Nice To Haves

One year of clinical research experience.
Clinical Research Coordinator certification through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA).
Knowledge of Good Clinical Practice (GCP) guidelines and applicable U.S. Department of Health and Human Services and U.S. Food and Drug Administration regulations related to human subjects research.
Familiarity with International Council for Harmonisation (ICH) guidelines and HIPAA privacy requirements as they apply to clinical research.

Responsibilities

Coordinate and manage clinical research studies from initiation through completion, including participant screening, recruitment, scheduling, and study visits.
Conduct research activities in accordance with study protocols, Good Clinical Practice guidelines, federal and state regulations, and organizational policies.
Maintain accurate and complete study documentation, including regulatory files, informed consent and privacy authorization forms, IRB approvals, source documentation, case report forms, study communications, and drug or test article accountability records.
Work closely with investigators to prepare research protocols and supporting materials for Institutional Review Board (IRB) submission and approval.
Coordinate ongoing communication with the IRB regarding protocol amendments, informed consent, safety information, adverse events, protocol deviations, and continuing reviews.
Collaborate with investigators and organizational leaders on the financial and administrative aspects of clinical trials.
Assist with research applications, study agreements, confidentiality agreements, and clinical trial agreements.
Collaborate with departments across the organization to prepare for and implement new research protocols.
Support efforts to identify, market, and recruit new clinical trials to the organization.
Promote participant safety by ensuring study-related laboratory testing and other protocol requirements are appropriately completed.
Protect the confidentiality and privacy of research participants in accordance with applicable federal and state regulations and HIPAA requirements.
Maintain current knowledge of clinical research regulations, guidelines, and institutional requirements.
Contribute to quality improvement, patient and staff safety, and a culture of respect and inclusion.