Feasibility Coordinator

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 Sylvester Comprehensive Cancer Center has an exciting opportunity for a Full-time Feasibility Coordinator to work in the UHealth Campus. The Feasibility Coordinator will work closely with the Study Start-Up team to ensure the timely activation of clinical research studies. Feasibility assessment is one of four major review gates that are required to activate studies at Sylvester Comprehensive Cancer Center. Primary Responsibilities: · Managing the entire feasibility process, which includes verification of site (UM) capabilities, communication with sponsor, oversight of execution of sponsor agreements, and close collaboration with the study teams to gather required documents. · Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (i.e. local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required. · Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations. This process will take place from study activation throughout the completion of the study. · Communicate with SDG Managers, Clinical Coordinators and PIs to review clinical trial pipeline, provide updates, and ascertain needs for clinical trials. · Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request. · Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request. This responsibility is sponsor dependent. 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 · High school diploma or equivalent · Minimum 3 years of relevant experience · Ability to maintain effective interpersonal relationships · Ability to communicate effectively in both oral and written form · Skill in collecting, organizing and analyzing data · Proficiency in computer software (i.e. Microsoft Office) Any appropriate combination of relevant education, experience and/or certifications may be considered. #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. Job Status: Full time Employee Type: Staff Pay Grade: c105 The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. Transforming lives With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe. The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.