Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work Hybrid at the UHealth Medical campus in Miami, FL. CORE JOB SUMMARY The Clinical Research Coordinator 2 (A) serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel. CORE JOB FUNCTIONS + Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility. + Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols. + Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations. + Maintains study binders and filings according to protocol requirements, UM and department policy. + Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator. + Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations. + Assists in implementing protocol amendments under direct supervision of the Principal Investigator. + Assists with study orientation and protocol related in-services to research team and clinical staff. + Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule. + Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments. + Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews. + Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc. + Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies. + 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. 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 Experience: Minimum 2 years of relevant experience Knowledge, Skills and Attitudes: + Skill in completing assignments accurately and with attention to detail. + Ability to analyze, organize and prioritize work under pressure while meeting deadlines. + Ability to process and handle confidential information with discretion. + Ability to work evenings, nights, and weekends as necessary. + Commitment to the University’s core values. + Ability to work independently and/or in a collaborative environment. Department Specifics: DUTIES & RESPONSIBILITIES: + 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. 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 (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information. Job Status: Full time Employee Type: Staff Pay Grade: A9