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The Department of Surgery has an exciting opportunity for a part time Clinical Research Data Specialist. The incumbent assists in enrolling subjects along with 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
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
- Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
- Maintains enrollment procedures according to the protocol.
- 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 issues from monitoring reports are addressed and closed out before 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. Study Database, 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.
Certification and Licensing:
- High school diploma or equivalent required. Some college level courses.
CITI Program: Human Subject Research, Group 1: Biomedical Researchers (HSR), good Clinical Practice (GCP) and Conflict of Interest (COI).Experience:
No experience requiredDEPARTMENT ADDENDUMDepartment Specific Functions
Adheres to all UM and department policies and procedures. Assists multidisciplinary team in research activities. 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.
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.
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.
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. Click here for additional information.Job Status:
Part timeEmployee Type: