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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work in the UHealth Medical campus in Miami, FL.

CORE JOB 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

+ 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

Certification and Licensing:

Clinical Research Coordinator certification preferred

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 Specific Functions

Bilingual in English and Spanish required. Assist the study investigators and work collaboratively in the preparation of IRB, NIH and other organization regulatory compliance reports. Supervise a team of undergraduate and graduate research assistants in the support of study activities Perform study-related tasks including participant recruitment and scheduling, administration of all measures, screening tools, intervention operationalization, and lead retention efforts. Be responsible for providing training and retraining to other team members as needed on all of these activities. Maintain and expand collaborative relationships with cancer clinics, physicians, and nurses and Sylvester Comprehensive Cancer Clinic. Support data management efforts, including QA/QC and data quality reporting, and maintenance of databases. Providing research support to Principal Investigators assisting with maintenance of databases, coordinating weekly research meetings, assisting with literature reviews/searches and manuscript preparation. Facilitate sample collection, processing and storage. Oversee CITI-training in the Protection of Human Participants and OSHA-mandated training related to the handling of physiological specimens. Other duties as assigned.

Knowledge, Skills and Attitudes:

+ Excellent and professional communication skills, including communicating within a team, with clinical care providers, with patients, and in all forms (verbal, written)

+ Proactive and creative problem solving, and able to adapt quickly to evolving challenges and dynamic work environments

+ Familiarity with community-based research as well as clinic-based research.

#LI-YC1

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