Clinical Research Coordinator 1

University of Miami•Miami, FL

1d•Onsite

About The Position

The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work onsite on the UHealth campus. This full-time position, Clinical Research Coordinator 1 (hereafter, "Coordinator"), will support two ongoing research programs within the University of Miami Division of Infectious Diseases: the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort and the ADELANTE clinical research study. Both projects are conducted within an HIV clinical care setting and involve direct interaction with adults living with HIV. The Coordinator will perform a variety of patient-facing clinical research activities while working closely with investigators, clinicians, research staff, and community partners to ensure successful study implementation and participant retention.

Requirements

Bachelor’s degree in relevant field required
Minimum 1 year of relevant experience
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.
Commitment to the University’s core values.
Ability to work independently and/or in a collaborative environment.

Nice To Haves

Bilingual proficiency in English and Spanish is highly desirable, as a significant proportion of study participants are Spanish speaking
Ability to work evenings, nights, and weekends as necessary.

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.
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.
Coordinates study visits by scheduling participant appointments and collaborating 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.
Performs 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.
Assists with the collection, labeling, processing, storage, and shipment of clinical specimens according to protocol and institutional procedures.
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.
Assists with reporting adverse events, protocol deviations, and other study-related issues to the Principal Investigator and research leadership, following applicable regulatory requirements.
Participates in study team meetings, trainings, and quality improvement activities.
Supports research activities within the HIV clinic while providing professional, culturally sensitive, and participant-centered interactions.
Assists with 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.