Clinical Research Coordinator 2
University of Miami

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The Department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work in Miami, FL. 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. This position requires attendance in person. Position will require some longer days, depending on protocols.

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

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.
  

Department Specific Functions

• 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
  
• Meets with monitors
  
• 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)
  
• Responsible for ordering any and all supplies required for conducting clinical studies
  
• Assist Division Administrator with Nephrology budget preparation providing reports of Clinical Research accounts and assist in clearing accounts for Fiscal year close-out
  
• Prepare and present status of study enrollment, of active participants, and of discontinued participants during the nephrology research monthly meeting,
  

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:
r6

This job has expired.