Clinical Research Coordinator 1

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The Clinical Translational Research Site is currently seeking a full time Clinical Research Coordinator 1 to work in Miami.

CORE JOB SUMMARY: The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.

CORE RESPONSIBILITIES: • Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol. • Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation. • Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision. • Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur. • Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants. • Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. • Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences. • Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies. • Knows the contents and maintenance of study-specific clinical research regulatory binders. • Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. • Adheres to University and unit-level policies and procedures and safeguards University assets.

CORE QUALIFICATIONS:

Education: Bachelor’s degree in relevant field

Experience: Minimum 1 year of relevant experience

Knowledge, Skills and Attitudes: • Skill in completing assignments accurately and with attention to detail. • Ability to analyze, organize and prioritize work under pressure while meeting deadlines. • Ability to process and handle confidential information with discretion. • Ability to work evenings, nights, and weekends as necessary. • Commitment to the University’s core values. • Ability to work independently and/or in a collaborative environment.

Department Specific Functions 1. Conducts or supports the informed consent process only after training, competency validation, and delegation; ensures current IRB-approved documents are used and filed. 2. Collects, enters, verifies, and maintains study data in approved systems; completes source documents and CRFs/eCRFs and responds to routine queries. 3. Communicates routine study updates, scheduling needs, missing documentation, and risks to the PI, supervisor, and study team. 4. Prepares and routes routine IRB submissions, amendments, continuing reviews, closures, and supporting documents under supervision. 5. Collects and maintains CVs, licenses, training certificates, financial disclosures, delegation records, credentialing materials, safety reports, and other essential documents. 6. Assists with sponsor/CRO document requests, site qualification, activation, monitoring visits, audits, and close-out activities. 7. Performs routine quality-control checks of source documents, data, consent records, and regulatory files; corrects deficiencies using approved processes. CTRS Department Specific Core JD Addendum 8. Maintains inspection-ready records for assigned tasks and completes remediation before independent performance when competency has not been demonstrated 9. Demonstrates learning agility, reliability, professional communication, teamwork, time management, and responsiveness to coaching. 10. Participates in onboarding, shadowing, direct observation, mock exercises, and competency reassessment; seeks assistance before acting outside training or delegation. 11. Travel across different locations if necessary

Department Specific Qualifications

Experience: Bilingual in English and Spanish is preferred but not required. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status: Full time Employee Type: Staff