Manager, Research Support (PRMC)
University of Miami

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The department of SCCC Clinical Research has an exciting opportunity for a full-time Manager, Research Support to work on the UHealth campus. The individual will manage activities pertaining to the Protocol Review and Monitoring Committee (PRMC) which primary goal is to ensure that institutional, industry-sponsors, and externally peer reviewed cancer research studies involving human subject conducted under the auspices of the SCCC are (1) scientifically and statistically sound; (2) appropriately designed; (3) feasible for completion; and (4) if applicable, in compliance with NIH guidelines for clinical trials. This position reports to the Director of Research Support (SCCC Clinical Research). The individual in this position will be expected to collaborate with the staff assigned to the parallel Protocol Review and Monitoring Committees existing at the SCCC.

CORE FUNCTIONS

• Oversees laboratory equipment purchase, use, maintenance, repair, and inventory.
  
• Manages service contracts.
  
• Trains laboratory staff on how to use laboratory equipment, laboratory techniques, and safety procedures.
  
• Prepares laboratories for annual safety inspections.
  
• Coordinates seminars and special activities in relation to research and laboratory safety.
  
• Oversees the management of laboratory animals.
  
• Collaborates with IT to maintain laboratory computers and servers running smoothly.
  
• Assists with arrangement of laboratory guests, speakers, and recruitment visits.
  
• Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
  

CORE QUALIFICATIONS

• Bachelor's Degree required; Degree in Health/Biomedical, BS, MSc or other related scientific degree/qualification preferred
  
• Minimum 3 years of relevant experience required; Experience in project management is preferred.
  
• Proficiency with Microsoft Word, Microsoft Excel and Microsoft Outlook. Must possess excellent communication skills.
  

Knowledge, Skills and Attitudes:

• Knowledge of business and management principles.
  
• Ability to direct, manage, implement, and evaluate department operations.
  
• Ability to establish department goals, and objectives that support the strategic plan.
  
• Ability to effectively plan, delegate and/or supervise the work of others.
  
• Ability to lead, motivate, develop, and train others.
  

Department Specific Functions

• Triage initial protocol submissions for either full review or expedited review with the assistance of the Committee Chair/Co-Chair.
  
• Triage amendment submission for either administrative review/release, expedited review, or full review with the assistance of the Committee Chair/Co-Chair.
  
• Manage the initial protocol/amendment submission process by coordinating with the:
  
• PI, Study Coordinator and/or Regulatory Specialist to obtain all necessary documents required for PRMC review and approval.
  
• Review all submission materials to ensure accurate information and a timely PRMC review requesting changes/clarifications when needed.
  
• Confirm stated changes/modification have been made in all of the appropriate places.
  
• Assign reviewers and assure a quorum for each Committee Meeting.
  
• Assess, translate, and communicate all questions and concerns of the PRMC Committee to the PI/Study Team/Regulatory Specialist/Research Manager in a way that will facilitate accurate and timely responses.
  
• Issue approval letters and coordinate with other ancillary committees when needed.
  
• Communicate with members regarding attendance, quorum, assignments, meeting issues and reviews.
  
• Attend meetings, document attendance/actions, draft minutes/ determinations for review by Chair/Co-Chair/Committee Members.
  
• Develop methods to assess PRMC productively in order to demonstrate accurate and timely review of initial protocol and amendment submissions. Identify adjustments to the process to enhance and/or streamline the review of initial protocol submissions and amendments.
  
• Organize storage of hard copies of committee and protocol files. These files include but are not limited to: determinations (signed), agenda, attendance sheet (signed), minutes, Determination Letters (signed) and any other relevant protocol related correspondence or actions.
  
• Develop data collection tools/databases with IT as needed to facilitate efficient and accurate reporting.
  
• Collaborate with PRMC Chairs and SCCC leaders to assure that the committee is appropriately organized and staffed to complete the responsibilities outline in the CCSG (P30).
  
• Participate in CAPA plans across the Cancer Center aimed to improve communication and decrease protocol deviations/violations if applicable to PRC activities/oversight.
  
• Establish and conduct routine quality assurance reviews of practices.
  
• Train/Supervise existing and/or new staff hired to support the PRC.
  

Any appropriate combination of relevant education, experience and/or certifications may be considered.

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

This job has expired.