Job location: Deerfield Beach, FL Employment Type: Full-time Posted data: 2019-10-24 Req: R100035931 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.
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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 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.
RESPONSIBILITIES: 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.
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 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.
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Job Status: Full time Employee Type: Staff Pay Grade: r4