Sr. Clinical Research Coordinator
Job location: Miami, FL
Employment Type: Full-time
Posted data: 2019-09-11
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The Sylvester Comprehensive Cancer Center is actively seeking a Sr. Clinical Research Coordinator. The Sr. Clinical Research Coordinator (CRC) will assist the Principal Investigator in the conduct all aspects of the clinical trial, including regulatory tasks, under the direct supervision of the Principal Investigator, and Clinical Research Manager. The CRC provides operational and administrative support in the management of patients accrued to multiple research protocols to assure subjects’ safety and regulatory compliance. The CRC is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, Standard Operating Procedures and all applicable regulations and guidelines and ensuring effective data flow associated with research protocols.
- Reviews and administers informed consent forms to study participants.
- Coordinates the recruitment, randomization, and follow-up of study participants in clinical research trials.
- Conducts regular quality assurance and checks across assigned studies and trials.
- Confirms subject records are well organized, secured, and labeled correctly.
- Prepares, submits, and monitors the flow of IRB documents, DSMB reports, and other reports.
- Notifies the IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations.
- Ensures that study personnel qualification and certifications, and training (e.g. CITI) documents are current.
- Ensures compliance with the protocol and in accordance with ICH-GCP during study visits, assessments, tests, therapy, interventions, accurate labeling of all tests, etc.
- Provides in-service education to staff and patients/participants about research protocols, research assessments, and other study related activities.
- Coordinates activities between departments to accomplish study goals under the direction from Principal Investigator and/or Project Manager. 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.
- Bachelor’s degree in relevant field
- Minimum 5 years of relevant experience
Knowledge, Skills and Attitudes:
- Skill in completing assignments accurately and with attention to detail.
- Skill in excellent written and verbal communications.
- Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
- Ability to process and handle confidential information with discretion.
- Ability to exercise sound judgment in making decisions and escalating matters when appropriate.
- Ability to work evenings, nights, and weekends as necessary.
- Ability to work independently and/or in a collaborative environment.
- Previous experience working with psychiatric/psychological protocols preferred.
- Commitment to the University’s core values.
Any appropriate combination of relevant education, experience and/or certifications may be considered.
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.
University of Miami offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. https://www.hr.miami.edu/careers/employment-laws-eo/index.html
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami 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 timeEmployee Type:StaffPay Grade:r7