Clinical Research Data Specialist (A)

University of Miami; Miami (FL); On-site; USD 55,000 - 82,000; Full time

Job summary

University of Miami is seeking a Clinical Research Data Specialist to assist in creating, updating, and maintaining research charts and case report forms in accordance with SOPs. This role supports data compilation, submission, and monitoring for protocol adherence under PI supervision.

The position involves extracting data from EMRs and other sources, managing multiple studies, addressing data queries, and coordinating with monitors.

Qualifications

• High school diploma or equivalent required.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to process and handle confidential information with discretion.
• Willingness to work evenings, nights and weekends as necessary.

Responsibilities

• Extracts clinical data from EMRs and other sources and enters into data capture system.
• Manages workload commensurate to experience across studies.
• Answers data clarifications for each study.
• Schedules and coordinates with study monitors and ensures readiness for visits.
• Develops source data worksheets for assigned studies.
• Ensures data in monitoring reports is addressed and closed out.
• Maintains logs (e.g., TAS submissions, Velos) per SOPs.
• Participates in site initiation visits and monitoring visits as required.
• Assists multidisciplinary team in research activities.
• Maintains study binders and filings per protocol requirements.
• Adheres to UM and department policies and procedures.
• Compiles patient data for investigator review to determine eligibility.

Skills

Attention to detail

Data analysis

Discretion with confidential data

Evenings/nights/weekends flexibility

Independent and collaborative work

Education

High school diploma or equivalent

Job description

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

1. 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.
2. Manages a workload of studies commensurate to level of experience
3. Answers data clarifications (i.e. data queries) for each study.
4. Schedules and meets with study monitors and assure patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
5. Develops source data worksheets specific to each assigned study.
6. Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
7. Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
8. Maintains logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs.
9. Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
10. Assists multidisciplinary team in research activities.
11. Maintains study binders and filings according to protocol requirements and department policy.
12. Adheres to all UM and department policies and procedures.
13. Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
14. Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
15. 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.
16. Adheres to University and unit-level policies and procedures and safeguards University assets.

CORE QUALIFICATIONS

Education: High school diploma or equivalentExperience: no experience requiredKnowledge, 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. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status:Full timeEmployee Type:Staff