Clinical Research Coordinator 2 at University of Miami in Miami, Florida

Job Description:

Current Employees:



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The SCCC CRC 2 (Quality Control coordinator) is responsible for ensuring all data collected is reviewed for quality control (QC) and is compliant with study and non-study regulations, including, but not limited to the study protocol, HIPAA, GCP, GDP, CFR, ICH Guidelines and site Standard Operating Procedures (SOPs). Responsible for the timeliness, quality, and accuracy of all work and ensured that issues identified through our QC processes are reported to the supervisory team and addressed in a timely manner.



CORE JOB FUNCTIONS

1. Assists in participant recruitment and retention activities and assists in screening potential study
participants for eligibility.
2. Performs study procedures, routine tests, data collection/recording, and daily operations of moderate
risk clinical research protocols.
3. Collects, processes, packs, and ships specimens according to protocol, applicable standards and
regulations.
4. Maintains study binders and filings according to protocol requirements, UM and department policy.
5. Distributes study drug materials according to practice standards and clinical credentials as delegated by
the Principal Investigator.
6. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol
deviations.
7. Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
8. Assists with study orientation and protocol related in-services to research team and clinical staff.
9. Monitors protocol implementation and study progress; keeps investigators fully apprised of study
progress; submits progress reports according to established schedule.
10. Learns the research team and assists with communications/interactions with sponsor, data coordinating
centers, compliance monitors, collaborators, investigators' academic administrative personnel, and
departments.
11. Assists in administrative tasks of study personnel including orientation, documenting core competencies,
certification mandates, safety/responsible conduct of research education, and performance reviews.
12. Adheres to cultural competency guidelines; implements strategies to meet study participants' needs for
language translation, health literacy, etc.
13. Follows the appropriate fundamental requirements of all international, national, and local regulatory
bodies.
14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research,
continuing education, and research competencies.
15. 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:
Bachelor's degree in relevant field


Experience:
Minimum 2 years of relevant experience


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.


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:

Full time



Employee Type:

Staff



Pay Grade:

A9