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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Clinical Research Coordinator 1 to work at UHealth in Miami, Florida.
CORE JOB SUMMARY
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
1. Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
2. Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
3. Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
4. Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
5. Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
6. Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
7. Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
8. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
9. Knows the contents and maintenance of study-specific clinical research regulatory binders.
10. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
11. Adheres to University and unit-level policies and procedures and safeguards University assets.
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
Education: Bachelor’s degree in relevant field required
Experience: 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.
Department Specific Functions
- The coordinator will maintain and expand collaborative relationships with healthcare clinics, physicians, and nurses within our community.
- The coordinator will also assist the investigators and work collaboratively in the preparation of IRB, NIH and regulatory compliance reports.
- The coordinator will travel regularly to Sylvester clinics and to community partner sites, including Federally Qualified Health Center (FQHC) clinics across Miami-Dade County, to identify, recruit, screen, and consent study participants in person. Local travel between clinic sites is required.
- The coordinator will conduct the informed consent process in person and remotely, ensuring participants understand study aims, procedures, risks, and benefits, and will document consent in REDCap.
- The coordinator will build and manage study records in REDCap, including record creation, survey distribution and completion, tracking reports, and participant communication tools, and will monitor study email accounts daily for new referrals and undelivered survey notifications.
- The coordinator will schedule, track, and complete participant assessment timepoints and follow-up contacts, and will implement retention strategies to minimize loss to follow-up.
- The coordinator will work with clinic champions, providers, nurses, medical assistants, and site administrators to secure clinic space, equipment, and workflows for study activities, such as the delivery of survivorship care plans to patients.
- The coordinator will communicate with participants’ clinical care teams regarding appointment adherence, care plan referrals, and changes in patient status, as specified by the protocol.
- The coordinator will attend and prepare for recurring study meetings, including stakeholder meetings, coordinator check-ins, and working group sessions, and will keep the study Program Manager informed of progress and barriers between meetings.
- The coordinator will prepare regular reports on screening, enrollment, retention, and data completeness for the PI and Program Manager, and will perform routine quality assurance checks on study data.
- The coordinator will prepare and manage study materials and supplies across sites, maintain source documents and participant binders according to good documentation practices, and support monitoring visits and audits.
- The coordinator will request and obtain relevant medical records from participants’ oncology care teams, review the records for study-related information, and ensure participant records in REDCap are updated accurately and in a timely manner.
Experience:
Research Experience in Community Settings
Recruiting and assessing cancer survivors
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 timeEmployee Type:
Staff