Sr. Manager, Research Support
Job location: Miami, FL
Employment Type: Full-time
Posted data: 2021-01-20
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The Individual will be responsible for the day to day management of Clinical Research Services (CRS) clinical research staff who are assigned to multiple site disease groups (SDGs). Management would include the oversight of over 125 clinical research protocols, which have resulted in the accrual of over 250 patients in the last year. Subsequently, the CRS clinical research manager will manage approximately 700 ongoing clinical research patients. The Sr. Manager will be managing the portfolio of studies for neuro-oncology, sarcoma, and pediatrics. They will manage a staff of clinical research coordinators and data managers. The candidate will communicate with sponsors and Investigators during the entire process from study offering to close out.
DUTIES AND RESPONSIBILITIES:
- Manage multiple CRS clinical research staff assigned to Site Disease Groups (SDGs).
- Individual will be responsible for clinical research team recruitment, screening, interviewing, hiring, performance evaluations, counseling, etc.
- Manage the initiation of continuing educational programs for CRS clinical research staff, including the facilitation of the clinical research staff licensing, certifications, training, Continuing Education Units (CEUs) through the use of in-services, guest lectures, workshops and other in-house seminars. Ensure clinical research staff participate in outside educational conferences and workshops as warranted.
- Perform all necessary clinical research staff training to ensure compliance with the protocol, CRS Standard Operating Procedures (SOPs), sponsor requirements, the federal regulations, Good Clinical Practice guidelines and UM policies and procedures.
- Work with the Regulatory Manager and Financial Manager in the development and maintenance of the CRS SOPs. Create clinical research staff orientation manuals, implement necessary systems, processes, and procedures for the support of clinical trials research. This includes overseeing the creation and maintenance of policies and procedures as they relate to regulatory affairs, quality assurance, financial affairs, and all affiliate networks.
- Performs all CRS clinical research staff training. Ensures the implementation of training is implemented into daily research procedures. Assess and monitor the implementation of the training and identify noncompliance. Performs follow-up training as required.
- Review all new studies and manage the creation of the clinical protocol design, the protocol’s development, and its preparation for implementation. Working with Quality Assurance staff, ensure all required systems and processes are in place prior to a new protocol’s implementation.
- Ensure all clinical research duties/tasks performed by clinical research staff are implemented/performed as per the requirements of the protocol, sponsor requirements and guidelines, the federal regulations and Good Clinical Practice guidelines and UM policies and procedures.
- Independently responds to any variance and implements corrective actions. Manages all audits. Manages all communication with the sponsor and outside agencies as required.
- Perform and manage the assignment of workload to clinical research staff.
- Perform quality review of clinical research staff performance. Reviews will need to be performed as needed and as required per UM policy to ensure patient safety and adequate monitoring of protocols.
EDUCATION & EXPERIENCE:
- B.S. degree in Nursing, Healthcare or another related field required. Master’s preferred.
- More than five years of work-related experience, including supervisory experience and three years’ experience in the site management of clinical trials. Experience conducting quality assurance reviews and data analysis preferred.
- Must have obtained one of the following certifications: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), Certified Clinical Research Professional (CCRP), and/or Oncology Research Nurse Certification. Must have excellent knowledge of the Code of Federal Regulations and Good Clinical Practice.
- Must have excellent skills in general computer applications (e.g., word, Outlook, Excel, Adobe, various electronic data capture (EDC) systems).
- Must have the ability to be trained in specialized database and statistical programs. Excellent English skills (both verbal and written) required
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 timeEmployee Type:StaffPay Grade:r8