University of Miami
Clinical Research Coordinator 2
University of Miami, Miami, Florida, us, 33222
Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER_eRecruiting_ApplyforaJob.pdf) .
The University of Miami Health System, "UHealth", Department of Medicine has an exciting opportunity for a Full -time Clinical Research Coordinator 2 to work at UHealth Medical Campus in Miami, FL.
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. This is a full-time regular position. Flexible hours may be needed to accommodate the needs of the clients - Some evenings and weekends. Local traveling involved. Travel to national meetings and trainings will also be required .
Core Responsibilities:
Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
P erforms 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 monito rs, 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:
In conjunction with research manager implements policies and procedures to accomplish project goals
Established and oversees research study personal and research flow procedures
Assists the PI and senior staff in preparing materials for submission to granting agencies and foundations.
Leads training and supervision of staff and research assistants.
Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule
In conjunction with project faculty develop policies, standard operating protocols and verifies and implements procedures to accomplish project goals and maintain research standards
Facilitates in the scheduling of appointments for participants and actively monitors recruitment staff schedules for opportunities to schedule appointments
Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants
Oversee procedures for collecting, processing and shipping bio-specimens to the designated bio-bank .
Maintenance and calibrations of study equipment (scales, centrifuges)
Verifies accuracy of research data and monitors data quality control
Helps prepares patient invoices for payments, repairs, trials, warranties etc.
Ensures data integrity and consistency
Helps develop forms for collections/summarizing data.
Maintains consent forms and sponsor correspondences.
Maintains required, records, and reports for administrative, quality assurance, safety and control purposes.
Manages all compliance issues related to the grants and contracts providing information on the requirements and deadlines for deliverables and work performed
Developed, manages and evaluations research reports for submission to research funding agencies as required by the project deliverables.
Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
Notifies IRB of protocol amendments, safety reports and serious adverse event etc. in compliance with applicable regulations.
Creates P.O's and orders all necessary items needed for the operational functionality
Conducts meetings with research staff and ensures functions are coordinated in a timely and accurate manner according to established guidelines.
Providing assistance with IRB processes (e.g., abiding by requirement for reporting safety or study deviations, initiating modifications to study procedures
As needed, assists and serves as a back up in study related procedures such as informed consent, obtaining survey data an d study related procedures
Participate in ongoing UM and research related trainings
Performs other related duties as assigned
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 required
Minimum 2 years of relevant experience. Bilingual (English and Spanish) preferred.
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.
Any relevant education, certifications and/or work experience 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
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER_eRecruiting_ApplyforaJob.pdf) .
The University of Miami Health System, "UHealth", Department of Medicine has an exciting opportunity for a Full -time Clinical Research Coordinator 2 to work at UHealth Medical Campus in Miami, FL.
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. This is a full-time regular position. Flexible hours may be needed to accommodate the needs of the clients - Some evenings and weekends. Local traveling involved. Travel to national meetings and trainings will also be required .
Core Responsibilities:
Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
P erforms 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 monito rs, 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:
In conjunction with research manager implements policies and procedures to accomplish project goals
Established and oversees research study personal and research flow procedures
Assists the PI and senior staff in preparing materials for submission to granting agencies and foundations.
Leads training and supervision of staff and research assistants.
Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule
In conjunction with project faculty develop policies, standard operating protocols and verifies and implements procedures to accomplish project goals and maintain research standards
Facilitates in the scheduling of appointments for participants and actively monitors recruitment staff schedules for opportunities to schedule appointments
Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants
Oversee procedures for collecting, processing and shipping bio-specimens to the designated bio-bank .
Maintenance and calibrations of study equipment (scales, centrifuges)
Verifies accuracy of research data and monitors data quality control
Helps prepares patient invoices for payments, repairs, trials, warranties etc.
Ensures data integrity and consistency
Helps develop forms for collections/summarizing data.
Maintains consent forms and sponsor correspondences.
Maintains required, records, and reports for administrative, quality assurance, safety and control purposes.
Manages all compliance issues related to the grants and contracts providing information on the requirements and deadlines for deliverables and work performed
Developed, manages and evaluations research reports for submission to research funding agencies as required by the project deliverables.
Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
Notifies IRB of protocol amendments, safety reports and serious adverse event etc. in compliance with applicable regulations.
Creates P.O's and orders all necessary items needed for the operational functionality
Conducts meetings with research staff and ensures functions are coordinated in a timely and accurate manner according to established guidelines.
Providing assistance with IRB processes (e.g., abiding by requirement for reporting safety or study deviations, initiating modifications to study procedures
As needed, assists and serves as a back up in study related procedures such as informed consent, obtaining survey data an d study related procedures
Participate in ongoing UM and research related trainings
Performs other related duties as assigned
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 required
Minimum 2 years of relevant experience. Bilingual (English and Spanish) preferred.
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.
Any relevant education, certifications and/or work experience 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