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Clinical Research Coordinator - $53K-75K per year

Company: University of Miami
Location: Homestead
Posted on: March 18, 2023

Job Description:

University of Miami is seeking a Clinical Research Coordinator for a job in Miami, Florida.Job Description & Requirements

  • Specialty: Clinical Research Coordinator
  • Discipline: Allied Health Professional
  • Start Date: ASAP
  • Duration: Ongoing
  • 40 hours per week
  • Shift: 8 hours, days
  • Employment Type: PermanentSoffer Clinical Research CenterThe Department of Obstetrics and Gynecology has an exciting opportunity for a Full-Time Clinical Research Coordinator 3 to work on the UHealth Campus. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies' daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study's integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.Coordinates the implementation of multiple complex clinical research protocols.Develops SOPs and templates with guidance from the PI/Clinical Research Manager.Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.Assist PIs and study team with regulatory IRB submissions, continuing reports, and modifications of protocols, including maintaining delegation of authority logs, deviation logs, adverse event logs for all studies.Assists PIs and study team with screening, recruitment, including informed consent of participants per protocol guidelines.Assists PIs and study team with scheduling and contacting study participants for appointments as needed.Assists PIs and study team with data collection, data entry and completing standard operating procedures for quality assurance reviews of data as needed.Assists PIs and study team with monitoring and tracking of study visits per protocol guidelines.Maintains required CITI Research Certifications and RSQA education for research support staff as mandated by the University and Supervisor.Assists PIs and study team with essential documentation including maintenance of study binders, shadow records, and record reviews for study specific data collection per protocols.Assists in the pre-award process for feasibility assessment, budget, and study start up as needed.Develops, verifies, and implements procedures to accomplish research goals.Implements research protocol and monitors participant adherence to protocol.Maintains database of department, providing research training and support, ensuring CITI certification and relevant trainings are up to date.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 requiredMinimum 4 years of relevant experience required, FDA experience highly desired/preferredCurrent Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 monthsSkill in collecting, organizing and analyzing data.Ability to recognize, analyze, and solve a variety of problems.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work independently and/or in a collaborative environment.Any appropriate combination of relevant education, experience and/or certifications may be considered.#Li-TF1The 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.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.University of Miami Job ID #R100057926.About University of MiamiThe University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common mission of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making the University a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 16,000 faculty and staff from all over the world.Benefits
    • Holiday Pay
    • 403b retirement plan
    • Sick pay
    • Wellness and fitness programs
    • Employee assistance programs
    • Medical benefits
    • Dental benefits
    • Vision benefits
    • Benefits start day 1
    • Continuing Education

Keywords: University of Miami, Homestead , Clinical Research Coordinator - $53K-75K per year, Healthcare , Homestead, Florida

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