Clinical Research Data Specialist

University of Miami•Miami, FL

1d•Onsite

About The Position

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. The Clinical Research Data Specialist will manage the data functions and the conduct of research protocols under occasional guidance. Ensures the integrity and quality of research is maintained. Prepare documents and participate in internal and/or external compliance monitor review/audit by reviewing and reporting on findings as relates to protocol/data compliance. Collaborate with Principal Investigators and coordinators to document and report study enrollment, including protocol adherence, adverse events, and meeting enrollment goals. Collaborate with Principal Investigators and coordinators to ensure the quality and completeness of clinical data entry. Work with Principal Investigators and coordinators to discuss and clarify data ambiguities and inconsistencies. Collaborate with Investigators, study teams, Velos team and SCCC IT/Data team in coordinating logistics for tracking data collection, recordkeeping of participant demographic information, data entry and maintenance of databases. Review and approve responses to queries, supports complex queries, and works with Principal Investigators and coordinators on data issues. Work alongside Population Science Members to generate reports on current studies in the SDG portfolio. Work with the Population Science Members to identify studies in pipeline and assist Principal Investigator with identifying study requirements in accordance with protocol guidelines. Perform other related duties and participate in special projects as assigned.

Requirements

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.
Ability to work independently and/or in a collaborative environment.

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.
Prepare documents and participate in internal and/or external compliance monitor review/audit by reviewing and reporting on findings as relates to protocol/data compliance.
Collaborate with Principal Investigators and coordinators to document and report study enrollment, including protocol adherence, adverse events, and meeting enrollment goals.
Collaborate with Principal Investigators and coordinators to ensure the quality and completeness of clinical data entry.
Work with Principal Investigators and coordinators to discuss and clarify data ambiguities and inconsistencies.
Collaborate with Investigators, study teams, Velos team and SCCC IT/Data team in coordinating logistics for tracking data collection, recordkeeping of participant demographic information, data entry and maintenance of databases.
Review and approve responses to queries, supports complex queries, and works with Principal Investigators and coordinators on data issues.
Work alongside Population Science Members to generate reports on current studies in the SDG portfolio.
Work with the Population Science Members to identify studies in pipeline and assist Principal Investigator with identifying study requirements in accordance with protocol guidelines.
Perform other related duties and participate in special projects as assigned.