The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common purpose of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making UM a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 13,400 faculty and staff from all over the world. The Research Associate 1, under the supervision of the Principal Investigator and Clinical Manager, will assist in creating, updating, and maintaining the research charts and case report forms, including regulatory related issues, in accordance with the Clinical Research Services Department Standard Operating procedures (SOP’s). The incumbent will assist the PI in obtaining informed consent and document the informed consent process as required. He or she is also responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, Standard Operating Procedures, and all applicable regulations and guidelines. This position is responsible for ensuring that effective data flow associated with research protocols are in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines.JOB DUTIES & RESPONSIBLITIES:1. Assists the Monitors, Clinical research Coordinators and PIs in the organization and preparation of Site Initiation Visits (SIV).2. Attend site disease group tumor board meetings and site disease group collaborative meetings usually composed of PIs, sub-PIs, CRCs, IT, and Regulatory Staff. 3. Assist the Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.4. Assists PI in obtaining informed consent and documents the informed consent process as required. Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment. 5. Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures. Complete sand submits to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.6. Assist in the completion of protocol specific documents. Obtain relevant medical information from patient clinic charts/medical records. Maintain logs/progress reports to track both currently enrolled as well as follow-up participants. Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.7. Under the supervision of the Principal Investigator. Determine data to be collected and develop forms for collecting/summarizing data. Enter data onto case report forms and/or into computer database as appropriate. Complete corrections/queries required at audits/monitor visits. Ensure data integrity and consistency in computer database and written records.8. Assist the Clinical Study Coordinator for the entry of and maintenance of the patient calendar. Ensure protocol specific data is entered into Velos.9. Enters data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.10. Query data inconsistencies and revise case report forms in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines.11. Actively participates in monitoring visits/site audits, etc. Seek review and approval of the Principal Investigator.12. Assist the Clinical Study Coordinator to maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.13. Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.14. Provides support with study related procedures as required, i.e., EKG, laboratory and tumor assessment studies.15. Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center. 16. Engage in continuing education of research policies/guidelines. Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in field of expertise.17. Other duties as assigned.
BS degree in science, health care, or related field required. Must be able to work independently and collaborate with a team, must have experience in clinical settings, hospitals, etc. or prior experience in research. Excellent organizational skills and attention to detail required. Computer skills required. Microsoft Office skills (Outlook email, Word, Excel, Power Point) required. Excellent skills in English (both verbal and written) required. Any appropriate combination of relevant education, experience and/or certifications may be considered.
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 offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. The University of Miami is an Equal Opportunity/Affirmative Action-Veteran/Disability Employer. Come join us!
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University of Miami School of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.