Job Description
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The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work onsite on the UHealth campus. The Clinical Research Coordinator 1 serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. The incumbent is responsible for simple clinical research protocols and timelines.
CORE JOB FUNCTIONS - 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.
Department Specific Functions - Review medical records of patients at the University of Miami and Jackson Memorial Hospital for clinical research studies.
- Enter abstracted data from the medical record into structured RedCap data form or other electronic data capture system.
- Serve as research coordinator for multiple NIH-sponsored clinical trials.
- Maintains study files according to protocol requirements, UM and department policy.
- Recruit and screen participants, obtain informed consent, and follow participants according to study calendar.
- Ensure study medication is kept secure and under the appropriate temperature condition and maintain accurate study drug accountability.
- Ability to work independently and/or in a collaborative environment.
- Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
- Prepares IRB submissions including continuing reporting, reportable events, amendments and follow ups to IRB.
- Helps obtain patient specimens (e.g., blood) to be stored and shipped to the central research laboratory.
- Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
- Responsible for ordering and maintaining stock of necessary supplies.
- Assists with study orientation and protocol related in-services to research team and clinical staff.
- Support multiple liver disease research studies by performing a variety of duties.
- Bilingual (English and Spanish) preferred.
- Perform other duties as assigned by the PI.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS - Bachelor's degree in relevant field required
- Minimum 1 year of relevant experience required
Knowledge, Skills and Abilities: - Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
- Teamwork: Ability to work collaboratively with others and contribute to a team environment.
- Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
- Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.
Job Status: Full time
Employee Type: Staff
Pay Grade: A8
Job Tags
Full time, Temporary work, Work at office, Local area, Worldwide,