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The SCCC department is seeking a Clinical Research Coordinator 2. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role
assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.

Primary Responsibilities:

 1. Recruit patients for participation in the LEO (Lymphoma Epidemiology and Outcomes) protocol.  Works with principal investigator to determine eligibility.

2. Retrieve required lab and tissue specimens for all participating patients.

3. Works with patients to administer the series of required questionnaires,

4. Works with patients and satellite coordinators to ensure that all eligibility source documents are complete and eligibility checklists are complete.

5. Execute the plan developed for collection of protocol specific subject specimens, i.e.  blood specimen, tissue samples, etc. as per protocol. Works closely with research coordinators and nursing staff to ensure that specimens are collected as required.

6. Participates in weekly LEO conference calls as the responsible representative for the University of Miami.

7. Takes the lead in answering questions from nursing staff, pathology, and lab personnel regarding program requirements and specimen collection, processing, and shipping.  

8. Assists in maintaining /logs progress reports to track both currently enrolled as well as follow-up participants.  Enters logs into Synapse reporting system for evaluation by Mayo.

9. Reviews all medical records related to patient medical history and diagnosis, to include physical exams, labs, imaging results, medical history, treatment records, questionnaires, and enter all data into research specific electronic data capture system.

10. Monitors adherence to protocol.  Takes action to report and correct deviations or other problems.  Assisting with entering RNIs into IRB 7

11. Records and reports AEs, SAEs and UPs in compliance with federal regulations, the protocol and UM policies to the sponsor and/or IRB as directed by the PI.

12. Maintains logs including but not limited to the following: screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs and actively participates in monitoring visits and site audits.

13. Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.

14. Participates in annual LEO conferences with Principal Investigator and other specified staff.

15. Manages data quality assurance projects and data analysis of studies as requested by Principal Investigator.

16. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center and provides coverage for other CRS SDGs as needed. Other duties as assigned.

 Minimum Qualifications (Essential Requirements):

• BS degree in science, health care, or related field; bachelor's degree preferred.  A minimum of two years effective work-related experience in research, clinical settings, hospitals, etc. or study coordination is required. High-level interpersonal skills are required. Excellent English oral and written communication skills and strong computer skills are required. Experience with Medical terminology is preferred.

KSA

Ability to manage multiple tasks simultaneously.

Attention to detail & accuracy.

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.

Ability to work independently and/or in a collaborative environment

Commitment to the University’s core values.

Skill in completing assignments accurately and with attention to detail.

#LI-YC1

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.

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