Clinical Research Coordinator 2 - University of Miami
Coral Gables, FL
About the Job
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 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.
The Clinical Research Coordinator 2 will oversee recruitment, retention, data management and sponsor-reporting responsibilities in the Child and Adolescent Mood and Anxiety Treatment Program (CAMAT; www.miami.edu/childanxiety). Reporting to the CAMAT Clinical Director (Dr. Niza Tonarely-Busto) and Program Director (Dr. Jill Ehrenreich-May), the Clinical Research Coordinator 2 is anticipated that this person will oversee staff, graduate students, practicum students, and undergraduate volunteers in the recruitment of children and families with anxiety and related concerns at our Coral Gables location and satellite locations (in Miami Lakes and Homestead). Based out of the Department of Psychology on the Coral Gables campus, the Clinical Research Coordinator 2 will manage phone screening, intake assessments, scheduling of group and individual psychotherapy sessions, management of clinician assignments, participant surveys, participant waitlist, IRB protocol management, billing issues, outreach activities, and accrual of participant enrollment information for sponsor and donor sources to CAMAT. Spanish-language skills, extremely strong interpersonal and organizational skills, and experience with community-directed clinical trials or youth-directed research are strongly preferred. Some independent travel to outreach activities or satellite locations for data collection may be required.
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.
Department Specific Functions
+ Manages all screening, intake, and participant retention procedures in the Child and Adolescent Mood and Anxiety Treatment Program.
+ Manages participant accrual information to report to Program sponsors and donors.
+ Manages volunteer, practicum, and student engagement with participants enrolled in programs at the Child and Adolescent Mood and Anxiety Treatment Program.
MINIMUM QUALIFICATIONS
Education:
Bachelor’s degree in relevant field
Experience:
Minimum 2 years of relevant experience
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:
r6
The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.
The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride.
The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.
Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.
The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.
Transforming lives
With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.
The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.
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 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.
The Clinical Research Coordinator 2 will oversee recruitment, retention, data management and sponsor-reporting responsibilities in the Child and Adolescent Mood and Anxiety Treatment Program (CAMAT; www.miami.edu/childanxiety). Reporting to the CAMAT Clinical Director (Dr. Niza Tonarely-Busto) and Program Director (Dr. Jill Ehrenreich-May), the Clinical Research Coordinator 2 is anticipated that this person will oversee staff, graduate students, practicum students, and undergraduate volunteers in the recruitment of children and families with anxiety and related concerns at our Coral Gables location and satellite locations (in Miami Lakes and Homestead). Based out of the Department of Psychology on the Coral Gables campus, the Clinical Research Coordinator 2 will manage phone screening, intake assessments, scheduling of group and individual psychotherapy sessions, management of clinician assignments, participant surveys, participant waitlist, IRB protocol management, billing issues, outreach activities, and accrual of participant enrollment information for sponsor and donor sources to CAMAT. Spanish-language skills, extremely strong interpersonal and organizational skills, and experience with community-directed clinical trials or youth-directed research are strongly preferred. Some independent travel to outreach activities or satellite locations for data collection may be required.
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.
Department Specific Functions
+ Manages all screening, intake, and participant retention procedures in the Child and Adolescent Mood and Anxiety Treatment Program.
+ Manages participant accrual information to report to Program sponsors and donors.
+ Manages volunteer, practicum, and student engagement with participants enrolled in programs at the Child and Adolescent Mood and Anxiety Treatment Program.
MINIMUM QUALIFICATIONS
Education:
Bachelor’s degree in relevant field
Experience:
Minimum 2 years of relevant experience
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:
r6
The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation.
The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride.
The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings.
Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019.
The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022.
Transforming lives
With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.
The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.
Source : University of Miami