Clinical Research Coordinator 1

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.
• Captures routine activities of clinical studies including data collection and maintenance, planning study timelines, scheduling 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.
• Affirms adverse events, including those reported by study participants.
• 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.

Department Specific Functions

• Conducts participant recruitment and screening activities within the HIV clinic and through telephone outreach to identify potentially eligible participants.
• Explains research studies to prospective participants, obtains informed consent, and answers participant questions while maintaining ethical standards and participant confidentiality.
• Schedules participant appointments and collaborates with clinic providers and research staff to facilitate research activities.
• Collects research data through interviews, questionnaires, electronic patient-reported outcomes, and other study-specific assessments.
• Conducts chart review and medical record abstraction to support participant eligibility, study documentation, and data collection.
• Maintains accurate and timely study documentation, case report forms, source documents, enrollment logs, and regulatory records in accordance with study protocols and institutional requirements.
• Enters research data into electronic databases and assists with data quality assurance activities.
• Coordinates participant reimbursement and maintains documentation related to participant payments.
• Contacts participants by telephone, text message, email, or other approved methods to schedule visits, complete follow-up assessments, and promote participant retention.
• Works closely with investigators, clinic personnel, and collaborating research teams to ensure timely completion of study activities and protocol requirements.
• Affirms adverse events, protocol deviations, and other study-related issues to the Principal Investigator and research leadership, following applicable regulatory requirements.
• Supports research activities within the HIV clinic while providing professional, culturally sensitive, and participant-centered interactions.
• Affords additional clinical research activities as assigned in support of the CNICS cohort, the ADELANTE study, and other related research initiatives within the Miami CFAR Behavioral & Social Sciences Community Outreach Core.

Core Requirements

• Bachelor’s degree in relevant field required.
• Minimum 1 year of relevant experience.
• Bilingual proficiency in English and Spanish is highly desirable, as a significant proportion of study participants are Spanish speaking.

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.

Pay

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

Schedule

The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work onsite on the UHealth campus.