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Sr. Clinical Research Coordinator (Phase 1)

Employer
University of Miami
Location
Miami, FL

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Faculty Jobs
Arts & Humanities
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Academic Affairs, Research Staff & Technicians
Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details

Job location: Miami, FL


Employment Type: Full-time
Posted data: 2019-02-27
Req: R100028418
Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here 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.

Where Excellence Meets Purpose

The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.

With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful purpose 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.

The University has been named on Forbes's Best Employers list for two consecutive years, and is the only university in Florida to receive this honor.

The Sr. Clinical Research Coordinator will also conduct all aspects of the clinical trial, with the exception of issues assigned to regulatory personnel, under the supervision of the Clinical Manager or Director.  The Sr. Clinical Research Coordinator manages an assigned set of patients accrued to multiple research protocols to assure efficiency and compliance.  The Sr. Clinical Research Coordinator is responsible for screening and enrolling research subjects.DUTIES & RESPONSIBILITIES:

  •  Assist Principal Investigator and Sr. Manager with assessing feasibility.
  • Organizes and participates in Study Initiation Visits (SIV) in collaboration with the Study Team.
  • Attends site disease group tumor board meetings and site disease group collaborative meetings.
  • Works directly and communicates with SDG Leader and Sr.  Managers to meet SDG goals; maintains SDG protocol portfolio with assistance from CRS leadership and tracks accruals for SDG.
  • Participates in the orientation, mentoring, and coaching including Jr. Clinical Research Coordinator and Data Coordinator.  Identifies educational opportunities for members of disease cluster and ensures coverage for attendance when necessary.     
  • Provide patient and staff education (in-services) regarding all Site Disease Group (SDG) specific protocols. Assist the PI in providing the patient and his/her family with a thorough description of the treatment and possible side effects related to study treatments. 
  • Review patient data with the PI to determine patient eligibility for protocol enrollment. Ensure all eligibility forms are completed and submitted for appropriate review.
  • Assists PI in obtaining informed consent and document the informed consent process. Enter required information in Velos.
  • Ensure study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents.  Obtain relevant medical information from patient clinic charts/medical records.  Maintain logs/progress reports to track both currently enrolled as well as follow-up participants.  Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.
  • Participates in quarterly peer-review, quality control program.
  • Determine data to be collected and develop forms for collecting/summarizing data.  Work with the Data Coordinator to enter data onto case report forms and/or into computer database as appropriate.  Complete corrections/queries required at audits/monitor visits.  Ensure data integrity and consistency in computer database and written records.
  • Execute the plan developed for procurement of protocol specific subject specimens, i.e. pharmacokinetics, tissue procurement as necessary and ensures it is successfully completed.
  • Assists the Study Team that protocol lab kits and study specific supplies are obtained as required.
  • Ensure protocol specific data is entered into Velos.
  • Take action to report and correct deviations or other problems.  Verify accuracy of research data and monitor data quality control.  Record serious adverse events, etc. in compliance with applicable regulations and report to IRB/Sponsor.  Actively participates in monitoring visits/site audits, etc.
  • Promptly reports side effects of treatment to the Investigator and ensures Regulatory is provided accurate information to report to IRB. In turn, ensures appropriate patient follow up is performed and follow up safety reports are completed and provided to Regulatory as required per HSRO policies, protocol specific requirements, GCP, and the federal regulations.
  • Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
  • Ensure that randomization and registration of patients entered onto Cancer Center sponsored clinical trials are performed in compliance with CRS and UM policies, the protocol, GCP, and the federal regulations.
  • Establish/maintain contact with patients/participants, health care providers, community agencies, study sponsors.  Update appropriate agencies (such as sponsors, regulatory, etc.) regarding current status of research projects. 
  • Ensures work environment is organized and functions efficiently.  Participates in a collaborative, empowered work environment as demonstrated through teamwork.  Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center. Provide coverage for other CRS SDGs as needed
  • Engage in continuing education of research policies/guidelines. Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure, and/or keep abreast of latest trends in field of expertise.
  • Other duties as assigned.

Minimum Qualifications:
 

Education:Bachelor’s Degree in relevant field requiredMinimum 5 years of relevant experienceSkill 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.

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 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.



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:

r7

Organization

The University of Miami is one of America's top research universities located in one of the most dynamic and multicultural cities in the world.

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 mission of the University of Miami is to transform lives through education, research, innovation, and service

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.

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. With more than $413 million in research and sponsored program expenditures annually, the University of Miami is a member of the prestigious Association of American Universities (AAU). Only 3 percent of four-year institutions in the nation are invited to join the AAU, which recognizes breadth and quality of research and scholarship. While the majority of this work is housed at the Miller School of Medicine, investigators conduct hundreds of studies in other areas, including marine science, engineering, education, and psychology.

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.

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