Miami, Florida, United States · On-site
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…
Skills: Clinical Data Extraction, Case Report Forms, Regulatory Compliance, Electronic Medical Records, Data Query Resolution
Miami, Florida, United States · On-site
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Miami, Florida, United States · On-site
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Miami, Florida, United States · On-site
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Miami, Florida, United States · On-site
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Miami, Florida, United States · On-site
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Miami, Florida, United States · On-site
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Miami, Florida, United States · On-site
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…
Skills: Tissue Processing, Sectioning, Immunohistochemistry, Microtomy, Cryotomy
Miami, Florida, United States • On-site
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The specialist is responsible for creating and maintaining research charts and case report forms while ensuring data accuracy and regulatory compliance. They extract clinical data from electronic records and coordinate with study monitors to address queries and close out reports.
A high school diploma or equivalent is required, with no prior experience necessary. Candidates must demonstrate strong organizational skills, attention to detail, and the ability to handle confidential information.
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, please review this tip sheet.
The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Clinical Research Data Specialist to work at the UHealth campus in Miami, Fl.
The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
Manages a workload of studies commensurate to level of experience
Answers data clarifications (i.e. data queries) for each study.
Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
Develops source data worksheets specific to each assigned study.
Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
Maintains logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs.
Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
Assists multidisciplinary team in research activities.
Maintains study binders and filings according to protocol requirements and department policy.
Adheres to all UM and department policies and procedures.
Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
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.
CORE QUALIFICATIONS
Education:
High school diploma or equivalent
Experience:
No experience required
Knowledge, Skills and Attitudes:
Adheres to University and unit-level policies and procedures and safeguards University assets.
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.
Delivering leading-edge patient care by the region’s best doctors, powered by groundbreaking research at The U.
UHealth – University of Miami Health System delivers leading-edge patient care by top-ranked physicians who treat some of the most complex cases. Powered by the Miller School of Medicine’s ground-breaking research and medical education, UHealth is the region’s only academic-based health care system. With a comprehensive network of nearly 40 outpatient facilities, its flagship hospital in the heart of Miami’s Health District, and more than 2,700 physicians and healthcare providers across South Florida, UHealth is a vital component of the community that is leading the next generation of health care. UHealth is home to Bascom Palmer Eye Institute, the No. 1 ranked eye hospital in the nation by U.S. News & World Report, Sylvester Comprehensive Cancer Center, the region’s only NCI-designated cancer center, and Desai Sethi Urology Institute, dedicated to urologic research and discovery, and a neurology and neurosurgery program ranked in the top 25 in the nation. These programs along with 100 other specialties make UHealth a trusted destination for compassionate, research-based care. UHealth is dedicated to continually developing an inclusive and rewarding culture for our talent - including hiring pledges with Military.com, AARP and a growing list of partners. UHealth has been honored on Becker's Healthcare 150 Top Places to Work List, emphasizing our commitment to the well-being and growth of our incredible faculty and staff. We also received the 2024 Platinum Bell Seal Certification by Mental Health America (MHA). The University of Miami was recognized by Forbes as one of the Best Employers for Women in 2023 and 2022. You can learn more about opportunities at UHealth at careers.miami.edu.
Offices: 1400 NW 12th Ave, Miami, Florida 33136, US · 5555 Ponce De Leon Boulevard, Coral Gables, FL 33146, US · 8932 SW 97th Ave, Miami, Florida 33176, US · 8100 SW 10 ST Plantation, Plantation, FL 33324, US · 1150 NW 14th St, Miami, FL 33136, US
