Manager, Research Support at University of Miami in Miami, Florida

Posted in Other 9 days ago.





Job Description:


Current Employees:




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Transforming Lives



The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.


With more than 16,000 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.


The Sylvester Comprehensive Cancer Center has an amazing opportunity for a Manager, Research Support. The Manager, Research Support is responsible for direct oversight of all clinical research activities within the Phase 1 Clinical Trial Program of Sylvester Cancer Center. This program is South Florida's only Phase 1 Clinical Trial Program comprising of over 50 active trials across Oncology, Lymphoma, Leukemia and Melanoma. The responsibilities for this role include disease group program development in collaboration with disease site leaders and investigators, Quality, Regulatory, Compliance and Finance teams, diversification of experimental treatment options for patients, and personnel management for employees in the clinical research organization. In support of these activities, the Manager, Research Support is involved in continual process improvement to further the efficiency and effectiveness of the clinical research organization.


The Manager, Research Support is responsible for creating a caring and compassionate patient focused experience and serves as a liaison between investigators and industry partners as well as other stakeholders within the institution.


As someone with experience in leading and managing Chemotherapy, Radiation, Immunotherapy, and Oncolytic Virus trials, the Manager, Research Support will perform,


Site Disease Group Program Development




  • Collaborate with key stakeholders like Quality Management, Regulatory, Pharmacy, In-patient and Infusion Unit, Nursing and Finance team in the development of structure and workflow of research operations.

  • Collaborate with solid and/or liquid tumor disease group leader in defining strategy of disease group development through evaluation of study portfolio, projecting resourcing needs, providing appropriate information/metrics and other support as requested by the disease site leader. Hold regular meetings with the disease site leader for strategic discussions.

  • Communicate organizational information to the disease site leaders and team investigators in a timely manner.

  • Evaluate proposed studies to determine feasibility of conduct and ability to adequately resource in collaboration with disease site leader, study team, feasibility, protocol review monitoring and finance team.

  • Collaborate with key stakeholders to strategize expansion of Phase 1 program including but not limited to Network locations.

  • Work in partnership with investigators, Nurse practitioners, Nurse navigators and Research Coordinators to identify patients for Phase 1 clinical trials.

  • Lead Phase 1 Program meetings on a biweekly basis and attend disease group team meetings on an as needed basis.



Continuous Process Improvement

  • Ongoing evaluation of clinical research processes and procedures for opportunities to improve through efficiency, quality checks or other improvement methods. Information that might be considered includes audit/monitor findings, observed process gaps and other mechanisms.

  • Collaborate with Informatics team to develop tools as necessary for increasing efficiency of research operations.

  • Effectively communicate clinical process improvement opportunities, engage key stakeholders, and solicit feedback/engagement. Ensure appropriate documentation of procedures and training of staff members to new/revised requirements.

  • Assess outcomes of process changes to ensure the highest quality deliverables and most efficient approach.



Personnel Management


  • Identify, hire and on-board high-quality candidates who are committed to furthering the mission of the Sylvester Cancer Center's Clinical Research Unit.

  • Collaborate with Sylvester Cancer Center's Clinical Research Unit and assign mentorship for training of new staff members and staff members who are undergoing re-training, as appropriate.

  • Assess for and provide individualized professional development opportunities as appropriate and available for staff members.

  • Assess equity and appropriateness of compensation as appropriate.

  • Provide performance feedback to staff members on a regular basis that is timely, clear and actionable with documentation of that feedback captured when necessary.

  • Evaluate workload allocation for staff members and groups and redistribute, as appropriate. Provide back-up support for study management activities when necessary.



Fiscal Management


  • Provide disease and program expertise to assist the Finance Group in the development of appropriate study budgets.

  • Perform financial oversight for accuracy in research patient billing, study account health, and assist with trouble-shooting pre-award and post-award activities (invoicing, payments, and any problem situations etc.), as appropriate.

  • Collaborate with disease groups, investigators and the Finance Team to ensure accurate and complete study billing schedules, including ongoing oversight for amendments

  • 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.




Department Specific Qualifications




Education:



Bachelor's Degree in health sciences or other relevant field required



Preferred qualifications:



Master's degree in health sciences or other relevant field



Certification and Licensing:



Clinical research certification (SoCRA, ACRP)



Experience:



Minimum 3 years of relevant experience.



Knowledge, Skills and Attitudes:



  • Knowledge of cancer as a disease process, cancer treatment modalities, and clinical trial processes.

  • Experience working with biological agents and completion of relevant biosafety level 2 training.

  • Knowledge of business and management principles.

  • Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines that govern clinical research.

  • Ability to direct, manage, implement, and evaluate department operations.

  • Ability to establish department goals, and objectives that support the strategic plan.

  • Ability to effectively collaborate, plan, delegate and/or supervise the work of others.

  • Ability to lead, motivate, develop, and train others.



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:

r7
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