Clinical Research Coordinator 2

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The Miami Transplant Institute is currently seeking a Full-Time Clinical Research Coordinator 2 to work onsite in Miami. 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 RESPONSIBILITIES:

• 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 required.

Experience:

• Three years of relevant work experience in clinical trials management or research experience in clinical trial setting.

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:

• Ability to work evenings, nights, and weekends.

• Coordinates the implementation of multiple complex clinical research protocols.

• Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.

• Coordinates monitoring visits

• Assists during FDA or internal audits.

• Operates sponsor devices such as perfusion machines.

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. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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