Clinical Research Coordinator 1

University of Miami•Miami, FL

3d•Onsite

About The Position

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

Requirements

Bachelor’s degree in relevant field
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.
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.

Nice To Haves

Bilingual in English and Spanish is preferred but not required.

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.
Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
Collects, processes, and ships specimens according to protocol and regulations.
Maintains study binders and filings according to protocol requirements, UM, and department policy.
Distribute study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
Assists with study orientation and protocol-related in-services to the research team and clinical staff.
Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
Learns the research team and assists with communications/interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic, administrative personnel, and departments.
Assists in administrative tasks of study personnel, including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.
Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
Travel might be required in the local area.