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Sr. Clinical Research Coordinator

4 months ago

Miami, United States The University of Miami Full time
Current Employees:

If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

The Department of Physical Medicine and Rehabilitation is currently seeking a full time Sr. Clinical Research Coordinator to work in Miami. The Senior Clinical Research Coordinator oversees the compilation, registration, and submission of research data and monitors study compliance with research protocols. Further, the Senior Clinical Research Coordinator assists in coordinating research studies, developing protocols, and maintaining reporting needs per applicable rules and regulations.

CORE JOB FUNCTIONS
  • Reviews and administers informed consent forms to study participants.
  • Schedules patients for research related visits and contacts patients for clinical follow-up requirements.
  • Coordinates activities between departments to accomplish study goals.
  • Retains records of payments to study participants.
  • Completes patients' data forms and reviews medical charts for patients' vital signs and other medical data to complete case report forms.
  • Maintains records of study results and study participants.
  • Keeps active pool of study candidates to ensure availability.
  • Adheres to University and unit-level policies and procedures and safeguards University assets.

Department Specific Functions
  • Liaison with IRB and department researchers to clarify regulatory items - no actual submission responsibilities, unless assigned as the lead coordinator/nurse manager.
  • Submission of initial feasibility request with UM leadership
  • Route CDA/NDA/Other sponsored items with ORA/RIM
  • Advise resident physicians with completing regulatory (IRB) submissions
  • Assesses, troubleshoots, and reports problems with data collection to appropriate managing staff.
  • Identifies desired research outcomes and evaluates and monitors subjects' responses.
  • Initiates all regulatory items required for the study
  • Works with pre-award offices to route submissions for approval
  • Works with post-award office to submit billing invoices and track payments
  • Conducts initiation visits and registers patients in clinical studies.
  • Performs study data collection and entry using charts, correspondence, medical records, and relevant communications.
  • Identifies and procures equipment and supplies needed to fulfill project requirements.
  • Educates staff and subjects about protocols, treatment, possible side effects, and complications.
  • Prepares and processes new research proposals and amendments and continually monitors applications and adverse events.
  • Assists with study completion, data lock, study closeout, and archiving of study files to ensure completeness and continuity of all study data.
  • Completes ongoing checks of clinical data that has been entered on the case report forms to ensure accuracy, and corrects any inaccurate data.
  • Ensures expenditures for clinical studies are properly processed, including participant payments, procurement items, hospital charges, etc
  • 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 5 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:
A10