University of Miami este o universitate privată de cercetare din Coral Gables, Florida, care oferă programe de licență, studii postuniversitare și programe profesionale într-o gamă largă de discipline. Comunitatea sa academică include școli și colegii axate pe arhitectură, arte și științe, afaceri, medicină și alte domenii. Universitatea este recunoscută în special pentru cercetarea în științele marine și atmosferice, realizată prin Rosenstiel School, precum și pentru activitatea din domeniul sănătății prin Miller School of Medicine. Cu un corp studențesc divers, o viață sportivă activă și un angajament puternic față de implicarea în comunitate, University of Miami oferă un mediu incluziv pentru educație, cercetare și activitate profesională.
Clinical Research Coordinator I
Support clinical studies across the University of Miami’s academic health system. Coordinate participant screening, study data, regulatory records, and protocol compliance.
Descriere
- Review charts and pre-screen participants for study eligibility.
- Coordinate straightforward clinical research protocols and enrollment processes.
- Manage routine study operations, including data collection, timelines, appointments, visits, meetings, and project evaluations.
- Conduct moderate to complex research tests and experiments under supervision.
- Operate clinical research equipment and troubleshoot problems.
- Monitor and report adverse events to the PI or supervisor, and respond according to protocol.
- Identify, report, and help resolve protocol deviations and unexpected events.
- Comply with international, national, and local regulations.
- Maintain regulatory binders for assigned studies.
- Complete required safety, equality, responsible conduct of research, continuing education, and competency training.
- Collect, enter, verify, and maintain study data in approved systems; complete source documents and CRFs/eCRFs and handle routine queries.
- Update the PI, supervisor, and study team on study progress, scheduling, missing documents, and risks.
- Prepare and route routine IRB submissions, amendments, continuing reviews, closures, and related documents under supervision.
- Keep essential records current, including CVs, licenses, training certificates, financial disclosures, delegation records, credentialing materials, and safety reports.
- Support sponsor and CRO document requests, site qualification and activation, monitoring visits, audits, and study close-out.
- Conduct routine quality checks and correct deficiencies through approved processes.
- Keep records ready for inspection and complete remediation before working independently when competency has not been demonstrated.
- Take part in onboarding, shadowing, direct observation, mock exercises, and competency reassessment.
- Ask for guidance before undertaking work beyond assigned training or delegation.
Cerințe
- Bachelor’s degree in a relevant field.
- At least one year of relevant experience.
- Accuracy and attention to detail when completing assignments.
- Ability to analyze, organize, and prioritize work under pressure and meet deadlines.
- Discretion when handling confidential information.
- Availability to work evenings, nights, and weekends as needed.
- Ability to work independently and collaboratively.
- Completion of training, competency validation, and delegation before conducting or supporting informed consent.
- English and Spanish bilingual ability preferred, but not required.
- Ability to travel between locations as needed.
Beneficii
- Competitive salary.
- Medical benefits.
- Dental benefits.
- Tuition remission.