University of Miami
Clinical Research Data Specialist
– Full Time, Staff, Pay Grade A6 – University of Miami/UHealth Department of SCCC at UHealth medical campus, 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. Manages a workload of studies commensurate to level of experience. Extracts clinical data and research data from electronic medical records and other sources and enters this data into the clinical paper-based or electronic data capture system for each assigned study. Answers data clarifications (data queries) for each study. Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and addresses items 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. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Maintains logs (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. High school diploma or equivalent. No experience required. 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. 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 provides leading‑edge patient care powered by groundbreaking research and medical education at the Miller School of Medicine. Our physicians represent more than 100 specialties and sub‑specialties, and have more than one million patient encounters each year. 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.
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– Full Time, Staff, Pay Grade A6 – University of Miami/UHealth Department of SCCC at UHealth medical campus, 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. Manages a workload of studies commensurate to level of experience. Extracts clinical data and research data from electronic medical records and other sources and enters this data into the clinical paper-based or electronic data capture system for each assigned study. Answers data clarifications (data queries) for each study. Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and addresses items 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. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Maintains logs (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. High school diploma or equivalent. No experience required. 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. 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 provides leading‑edge patient care powered by groundbreaking research and medical education at the Miller School of Medicine. Our physicians represent more than 100 specialties and sub‑specialties, and have more than one million patient encounters each year. 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.
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