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 University of Miami is currently seeking a Project Manager, Research Support to work at Soffer Clinical Research Center in Miami. The incumbent coordinates and leads efforts in a variety of research activities that are complex and wide in scope. Moreover, the Project Manager, Research Support operates with the goal of ensuring that the collection of data and administration of studies are performed efficiently and in compliance with applicable guidelines.
Core Job Functions
1. Aids in the evaluation of problems with workflow, organization, and planning and develops appropriate analytical approaches.
2. Maintains multiple protocol books and chronicles manuscript preparation.
3. Performs analyses of computerized datasets using standard packages to import, update, and manipulate datasets.
4. Presents studies' results at professional scientific meetings and conferences.
5. Writes manuscripts and journal articles for peer-reviewed medical journals.
6. Ensures that research program objectives are communicated, met, and results are documented.
7. Adheres to University and unit-level policies and procedures and safeguards University assets.
Department Specific Functions
•As Miami site Project Director, manages every aspect of Better Together, a randomized clinical trial testing a collaborative care model with medication for African Americans with Opioid Use Disorder.
•Works in collaboration with the Lead Investigators and the National Project Director of Better together, and with other site Project Directors to devise site-specific procedures (SOPs) for the implementation of the research project in Miami.
•Works under supervision of the Principal Investigator of the trial, Dr Szapocznik, and in collaboration with Dr. Horigian, an Investigator for this study.
•Ensures compliance with the research protocol, Manual of Operations, Safety Monitoring Plan, Local SOP's, Good Clinical Practices, and Federal Research Regulations for behavioral and pharmacological trials.
•Completes/maintains site-specific regulatory documentation and promptly provides regulatory materials to the Lead Regulatory Specialist for Better together; distributes approved regulatory materials to respective parties at the Miami site.
•Develops and implements local operating procedures (SOPs) for the implementation of the clinical trial at Jessie Trice, an affiliated site of the Florida Node Alliance, housed at UM.
•Coordinates recruitment and service efforts across multiple agencies (e.g., Jessie Trice, Circle of Brotherhood, local churches, IDEA exchange program) with the goal of linking study participants to Opiate Use Disorder (OUD) treatment at Jessie Trice. Coordinates with these agencies to connect participants to other services.
•Works in collaboration with community lead advisor, and the advisory board in identifying challenges for implementation and troubleshooting solutions with the Miami site investigator team.
•Oversees community outreach activities to recruit and retain black opioid drug users into opiate abuse treatment in the research study.
•Conducts in-person site visits: to Jessie Trice to oversee research activities and monitor study data/documentation; and to various community partner sites in the Miami area to maintain relationships and coordinate study-related activities.
•Oversees the research coordinator, the recruitment/outreach specialists and recovery guides that work in this study and ensures that they adhere to the protocol and manual of operations guidelines.
•Leads weekly team meetings of Site Principal Investigators, Study Physicians, Research Assistants, Outreach workers and recovery guides to: evaluate progress towards performance targets, troubleshoot solutions to achieve recruitment targets, treatment exposure, and availability of primary outcome; and review safety events to ensure appropriate monitoring, follow-up and reporting.
•Assists site research team in addressing implementation challenges, such as barriers to participant recruitment, and developing corrective action plans to address any performance deficiencies.
•Conducts remote and onsite clinical trial monitoring, tracks findings to resolution, and prepares formal monitoring reports for PI's and Sponsors, ensuring adherence to the study protocol and all applicable federal research regulations.
•Tracks study site performance and prepares and disseminates site performance reports
•Provides mentoring and consultation to the research coordinator and other research team members at the Miami site.
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
Certification and Licensing:
Not Applicable
Experience:
Minimum 3 years of relevant experience
#LI-FA1
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:
r8