Level II - Clinical Research Coordinator
Soffer Clinical Research Center
Miami, FL
5x8 hrs, Days

The Department of Medicine, Division of Rheumatology has an exciting opportunity for a Full-Time Clinical Research Coordinator 2 to work on the UHealth Campus. 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.
• Assists in the onboarding and training of new coordinators
• Reviews hospital and professional fee bills against study visits and study budgets to assure charges are correct
• Initiates new studies, coordinates, and participates in site initiation visits
• Prepare and submit study documents to IRB in support to launch a new study per sponsor and institution guidelines
• Prepare and submit amendments, continuing review reports, reportable events, case report forms and any other internal form to the IRB within time specified by study protocol, sponsor and institution guidelines
• Maintains velos, study visit binders, regulatory binders, and sponsor databases according to study protocol, institution, sponsors, and other regulatory agencies (e.g., 1572/investigator agreement, financial disclosure, curriculum vitae, IRB/IEC membership, lab-related documents, delegation of authority, site signature log).
• Performs QA on study binders and ensure site is prepared for any study monitor visits or audits by sponsor, regulatory agencies and CRO
• Prepare and submit regulatory documents to study sponsors according to specified guidelines
• Distribution of Sponsor correspondence re: Protocol changes, adverse events reporting and safety information and ensure that study team.
• Prepare and review with Principal Investigator’s clinical agreements/study budgets and informed consent forms for submission to the Clinical Research Initiation Service (CRIS) office for Medicare coverage analyses prior to IRB submission/finalization.
• Prepare and submit JHS CTO application forms for study review and approval for study initiation
• Assist Principal Investigators in the preparation of internal forms acquiring signatures to submit for required approvals from Research Administration/Department of Medicine for finalizing grants/clinical study agreement.
• When required, travel to attend Investigator’s/Coordinator’s Meetings/Steering Committee Meetings or Annual Study meetings
• Maintain up-to-date information regarding Study team/Investigator’s CVs and licenses. Responsible for assuring that Investigator’s and study staff are up to date with required certifications in order to conduct Clinical Research studies (i.e., CITI Course completion, HIPAA, or any other Study related training).
• Maintaining Emergency Stat Kit up to date ~ ordering replacement of any items which will/are out-of-date
• Responsible for maintaining Clinical Research laboratory in compliance with University policies and procedures, and meet requirements of applicable Federal, State and local regulations
• Responsible for setting up servicing/maintenance and calibration of study equipment (centrifuges, refrigerators, and freezers)
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.
MINIMUM QUALIFICATIONS
• Bachelor’s degree in relevant field required.
• Minimum 2 years of relevant experience
• 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.