Clinical Research Coordinator 2
University of Miami

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The department of Medicine, division of Hepatology, has an exciting opportunity for a full-time Clinical Research Coordinator to work onsite on the UHealth campus. Candidate will work within the Division of Digestive Health and Liver Diseases, but will be responsible for working with Investigators in other divisions on collaborative sponsored research studies.

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.

DEPARTMENT SPECIFIC FUNCTIONS

• Support multiple liver disease research studies by performing a variety of duties.
• Maintains study files according to protocol requirements, UM and department policy.
• Recruit and screen participants, obtain informed consent, and follow participants according to study calendar.
• Assist with the startup of new studies within the Goldberg lab.
• Assists in onboarding and training of new study team members.
• Oversee junior research coordinators.
• Performs QA on study binders in preparation of study monitor visits.
• Ensure study medication is kept secure and under the appropriate temperature condition and maintain accurate study drug accountability.
• Ability to work independently and/or in a collaborative environment.
• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
• Prepares IRB submissions including continuing reporting, reportable events, amendments and follow ups to IRB.
• Help process patient specimens (e.g., blood) to be stored and shipped to the central research laboratory.
• Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
• Responsible for ordering and maintaining stock of necessary supplies and participant incentives (submit payments in Workday, petty cash fund and/or gift card accounts).
• Assists with study orientation and protocol related in-services to research team and clinical staff.
• Review medical records of patients at the University of Miami and the Veteran Health Administration (VHA) for other clinical research studies.
• Enter abstracted data from the medical record into RedCap or other electronic data capture system.
• Participate in outreach events.
• Bilingual (English and Spanish) preferred.
• Perform other duties as assigned by the PI.

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

• Bachelor's degree in relevant field
• 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.

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 for additional information.

Job Status:
Full time

Employee Type:
Staff

Pay Grade:
A9

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