Clinical Research Data Specialist PT Temp
Clinical Research Data Specialist PT Temp
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Job Description
Current Employees:
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The Department of Surgery has an exciting opportunity for a (PT Temp) Clinical Research Data Specialist position. 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
Performs chart review/prescreening 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 paperbased 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 unitlevel policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be allinclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
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).
No experience required
DEPARTMENT ADDENDUM
Department 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 unitlevel policies and procedures and safeguards University assets.
Department Specific Qualifications
Education:
High school diploma or equivalent. Some college level courses.
Certification and Licensing:
CITI Program: Human Subject Research Group 1: Biomedical Researchers (HSR) good Clinical Practice (GCP) and Conflict of Interest (COI).
Experience:
No experience required
#LIGD1
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealthUniversity of Miami Health System South Floridas only universitybased health system provides leadingedge 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 subspecialties 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 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:
TemporaryPay Grade:
A6Required Experience:
Unclear Seniority
Employment Type
Part-Time
