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The Public Health Sciences Department at the University of Miami has an exciting opportunity for a

Clinical Research Coordinator 2 .

SUMMARY

The Clinical Research Coordinator 2 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

1. Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.2. Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.3. Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.4. Maintains study binders and filings according to protocol requirements, UM and department policy.5. Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.6. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.7. Assists in implementing protocol amendments under direct supervision of the Principal Investigator.8. Assists with study orientation and protocol related in-services to research team and clinical staff.9. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.10. Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.11. Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.12. Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.15. 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.

Certification and Licensing:Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates is optional.

Experience: Minimum 2 years of relevant experience

Previous experience working with oncology patients and recruiting in clinical care settings is desirable.

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 ADDENDUM

Department Specific FunctionsClinical Research Coordinator 2 will work coordinating a large, multi-site R01/R37 study funded by the National Cancer Institute. The goal of this study is to prospectively characterize symptomatic toxicities and health-related quality of life (HRQoL) among 416 diverse individuals with metastatic cancer who are initiating immune checkpoint inhibitors and identify multilevel predictors and clinical endpoints of toxicities and HRQoL over a 2 year follow-up period. This research will generate crucial knowledge to inform future intervention efforts to improve the safety and tolerability of checkpoint inhibitors and prevent and mitigate toxicities. Specific functions include:

1. Contribute to applied research activities by recruiting, collecting and analyzing data, maintaining databases, etc. 2. Understand and interpret research protocols and procedures for the project 3. Assist with developing, maintaining, and implementing standard operating procedures for the project 4. Carry out research activities in accordance with research protocols 5. Assist/coordinate day-to-day and large-scale study management 6. Assist/coordinate meetings among research team (internal and external) and prepare agenda for meetings 7. Assist with study start-up/preparing research materials (i.e., data collection instruments/study documents) 8. Assist with REDCap setup and managing REDCap data 9. Assist with coordinating and scheduling on-site visits with organizations 10. Assist with (and in some cases lead) on-site data collection: field observation notes/jottings, formal and informal interviews, reviewing strategy workflows/SOPs 11. Assist with data collection debriefs with PI and delegate of PI 12. Assist with qualitative data analyses and data integration (directed by PI and delegate of PI) 13. Assist with and conduct literature reviews 14. Coordinate and facilitate interviews and focus groups 15. Assist/coordinate recruitment efforts for implementers and organizations16. Assist with NIH progress reports and UM sponsored award reports 17. Collaborate with PI, collaborators, and other staff to publish findings in refereed journals 18. Complete weekly individual meetings with supervisor and prepare detailed agendas for meetings (as needed) 19. Lead or supervise extraction of clinical data from the EHR/EMR20. Advance knowledge related to job duties through continued education, training and/or research, as assigned by supervisor

The list of duties and responsibilities is not intended to be all-inclusive and may be expanded to other duties and responsibilities as necessary.

Note that this position may require occasional travel to San Antonio, Texas (1-2x per year) for site visits at UT Health San Antonio.

Department Specific Qualifications

Experience:Previous experience working with oncology patients and recruiting in clinical care settings is desirable.

Any appropriate combination of relevant education, experience and/or certifications may be considered.

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