The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 1 for the UHealth medical campus in Miami, FL.
The Clinical Research Coordinator 1 (A) 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.
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.
Assist Principal Investigator and Sr. Manager with assessing feasibility.
Organizes and participates in Study Initiation Visits (SIV) in collaboration with the
Study Team.
Attends site disease group tumor board meetings and site disease group collaborative meetings.
Works directly and communicates with SDG Leader and Sr. Managers to meet SDG goals; maintains SDG protocol portfolio with assistance from CRS leadership and tracks accruals for SDG.
Participates in the orientation, mentoring, and coaching including Jr. Clinical Research Coordinator and Data Coordinator. Identifies educational opportunities for members of disease cluster and ensures coverage for attendance when necessary.
Provide patient and staff education (in-services) regarding all Site Disease Group (SDG) specific protocols. Assist the PI in providing the patient and his/her family with a thorough description of the treatment and possible side effects related to study treatments.
Review patient data with the PI to determine patient eligibility for protocol enrollment. Ensure all eligibility forms are completed and submitted for appropriate review.
Assists PI in obtaining informed consent and document the informed consent process. Enter required information in Velos.
Ensure study protocol adherence, including completion of protocol specific procedures and 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.
Participates in quarterly peer-review, quality control program.
Determine data to be collected and develop forms for collecting/summarizing data. Work with the Data Coordinator to 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.
Execute the plan developed for procurement of protocol specific subject specimens, i.e. pharmacokinetics, tissue procurement as necessary and ensures it is successfully completed.
Assists the Study Team that protocol lab kits and study specific supplies are obtained as required.
Ensure protocol specific data is entered into Velos.
Take action to report and correct deviations or other problems. Verify accuracy of research data and monitor data quality control. Record serious adverse events, etc. in compliance with applicable regulations and report to IRB/Sponsor. Actively participates in monitoring visits/site audits, etc.
Promptly reports side effects of treatment to the Investigator and ensures Regulatory is provided accurate information to report to IRB. In turn, ensures appropriate patient follow up is performed and follow up safety reports are completed and provided to Regulatory as required per HSRO policies, protocol specific requirements, GCP, and the federal regulations.
Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
Ensure that randomization and registration of patients entered onto Cancer Center sponsored clinical trials are performed in compliance with CRS and UM policies, the protocol, GCP, and the federal regulations.
Establish/maintain contact with patients/participants, health care providers, community agencies, study sponsors. Update appropriate agencies (such as sponsors, regulatory, etc.) regarding current status of research projects.
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. Provide coverage for other CRS SDGs as needed.
Engage in continuing education of research policies/guidelines. Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure, and/or keep abreast of latest trends in field of expertise.
Other duties as assigned.
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.
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