Clinical Research Data Specialist 2

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Data Specialist 2 to work at the UHealth campus in Miami Fl.

CORE SUMMARY

The Clinical Research Data Specialist 2 independently creates updates and maintains research charts and case report forms including regulatoryrelated documentation in accordance with department standard operating procedures with limited supervision from the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist 2 is responsible for accurate and timely data compilation registration and submission ongoing monitoring of protocol compliance adherence to SOPs and all applicable regulations and guidelines.

CORE JOB FUNCTIONS

• Reviews and independently abstracts medical records for research participants across multiple assigned studies with moderate complexity.

• Extracts validates and enters clinical and research data from electronic medical records and source documents into paperbased or electronic data capture systems.

• Ensures data accuracy completeness and timeliness in accordance with protocol requirements and study timelines.

• Resolves and responds to data clarifications (i.e. data queries) independently escalating complex issues as needed.

• Coordinates and supports routine monitoring visits by preparing participant cases documentation and source data and by addressing postvisit followup items.

• Addresses and closes clinical and data discrepancies identified in monitoring reports prior to subsequent monitoring visits.

• Develops and maintains studyspecific source documentation and worksheets aligned with protocol and sponsor requirements.

• Maintains proactive communication with information services providers and research staff to support ongoing data collection and issue resolution.

• Documents and tracks studyspecific activities including monitoring visits enrollments protocol amendments and safety reports within the clinical trial management system in real time.

• Ensures all study documentation meets internal external sponsor and regulatory requirements in accordance with protocol guidelines.

• Maintains and audits studyrelated logs and tracking tools to support compliance and inspection readiness.

• Participates in site initiation visits monitoring visits and PI oversight or study team meetings contributing datarelated insight as appropriate.

• Supports and collaborates with multidisciplinary research teams to facilitate study execution and data integrity.

• Maintains organized auditready study binders and regulatory files and contributes to an efficient compliant and collaborative research environment.

• 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/relevant experience certification or license

Experience:
Minimum 2 years of relevant experience required

Knowledge Skills and Abilities:

- Learning Agility: Ability to learn new procedures technologies and protocols and adapt to changing priorities and work demands.

- Teamwork: Ability to work collaboratively with others and contribute to a team environment.

- Technical Proficiency: Skilled in using office software technology and relevant computer applications.

- Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

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 Floridas 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. Were the challenge youve 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.

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