Clinical Research Data Specialist (A)

University of Miami; United States; On-site; USD 42,000 - 68,000; Full time

Job summary

University of Miami is seeking a Clinical Research Data Specialist to support data capture, regulatory compliance, and study coordination within the research portfolio. The role emphasizes accurate data entry from EMR sources, timely issue resolution, and maintenance of study logs and filings.

The position requires strong attention to detail, data analysis, and the ability to work both independently and with a team.

Qualifications

• Education: High school diploma or equivalent.
• Experience: no experience required.

Responsibilities

• Extracts clinical data from EMR and other sources into data capture systems.
• Manage workload commensurate to experience for assigned studies.
• Respond to data clarifications (queries) for each study.
• Coordinate with monitors; prepare patient cases for visits.
• Develop source data worksheets for each study.
• Address issues from monitoring reports and close out before next visit.
• Ensure study requirements meet protocol and regulatory standards.
• Maintain logs (e.g., TAS submissions, Velos) per SOPs.
• Participate in site initiation visits and monitoring visits; attend SDG/PI meetings.
• Assist multidisciplinary team in research activities.
• Maintain study binders and filings per protocol requirements.
• Adhere to UM and department policies and procedures.
• Compile patient data for Investigator review to determine eligibility.
• Maintain logs for screening, enrollment, adverse events, deviations, etc.
• Foster a collaborative, professional work environment and effective teamwork.
• The duties may expand to include other responsibilities as needed.

Skills

Attention to detail

Data analysis

Prioritization

Confidential information handling

Flexible schedule

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

Job Status: Full time Employee Type: Staff

The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.