University of Miami
Clinical Research Data Specialist
University of Miami - Miami, Florida, us, 33222
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Clinical Research Data Specialist
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Clinical Research Data Specialist
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University of Miami Get AI-powered advice on this job and more exclusive features. 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. 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.
The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Hybrid Clinical Research Data Specialist to work at the UHealth Medical Campus in Miami, Fl
Core Summary
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.
Core Job Functions:
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.
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.
Core Qualifications
Education:
High school diploma or equivalent
Experience:
No Experience Required
Knowledge, Skills and Attitudes:
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
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 for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A6 Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Clinical Research Data Specialist
role at
University of Miami Join to apply for the
Clinical Research Data Specialist
role at
University of Miami Get AI-powered advice on this job and more exclusive features. 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. 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.
The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Hybrid Clinical Research Data Specialist to work at the UHealth Medical Campus in Miami, Fl
Core Summary
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.
Core Job Functions:
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.
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.
Core Qualifications
Education:
High school diploma or equivalent
Experience:
No Experience Required
Knowledge, Skills and Attitudes:
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
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 for additional information.
Job Status:
Full time
Employee Type:
Staff
Pay Grade:
A6 Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Health Care Provider Industries Higher Education Referrals increase your chances of interviewing at University of Miami by 2x Get notified about new Clinical Fellow jobs in
Miami, FL . Clinical Research Participant Specialist (A)
Research Fellow, MCVI Research, FT, 8A-4:30P
Coral Gables, FL $44,200.73-$57,460.95 1 day ago Research Fellow, MCVI Research, FT, 8A-4:30P
Research Associate 3, GI Surgical Oncology MCI, FT, 8:00A - 4:30P
Clinical Research Associate RN (Oncology)
Clinical Research Associate - Registered Nurse
Oncology Research Specialist II - FT - Days - MRH- Clinical Research
Internal/General Medicine Physician Needed for Examination Panel
Medicine- Medical Oncology, Assistant Professor
Clinical Research Associate RN (Oncology)
Staff Fellow - Medicine, Cardiovascular Advanced Imaging
Staff Fellow - Neurology (Neuro-Oncology)
Assistant Professor of Clinical - Medicine, Medical Oncology
Assistant Professor of Clinical - Medicine, Infectious Disease
Assistant Professor of Clinical - Medicine, Hospital Medicine
Clinical Specialist Pharmacy - Internal Medicine - FT - Days - $7,500 Sign on Bonus - MHM
Assistant Professor of Clinical - Medicine, Hospital Medicine
INTERNAL MEDICINE, PRIMARY CARE PHYSICIAN
Medicine Medical Oncology- Assistant Professor
Assistant Professor of Clinical - Medicine, Gastroenterology
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr