Manager, Clinical Research - Pediatrics Research Hub (PoRCH) Division

Location
Main Campus (Gainesville, FL)
Posted
Jan 13, 2021
Employment Type
Full Time
Institution Type
Four-Year Institution

Job no: 515490
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Agriculture/Life Science/Vet Medicine, Research/Scientific/Grants
Department:29090100 - MD-PEDS-ADMINISTRATION

Advertised: 11 Jan 2021 Eastern Standard Time
Applications close: 18 Jan 2021 Eastern Standard Time

Classification Title:

MGR, Clinical Research

Job Description:

The Clinical Research Manager (CRM) for the Pediatric Research Hub (PoRCH) will manage and direct Principal Investigator (PI) initiated studies and clinical trials. These duties will include recruiting, managing the research portfolio, assigning coordinators to studies, negotiating budgets, writing SOPs, coordinating communication for the study team, ensuring deadlines are met for each study, writing and editing IRB protocols, performing data collection and/or analyses, performing study feasibility analyses, developing surveys, creating data collection tools. The CRM will be responsible for the management and operations of projects managed by the PoRCH including data quality, accrual, OnCore quality assurance, coordination of study activities, and communication with the study team. The CRM may also be called upon to facilitate clinical and educational quality improvement and advocacy projects as needed.

The CRM will work closely with the faculty director to develop and manage the research portfolio for PoRCH with a focus on funded projects and clinical trials. The CRM will work closely with the faculty who have been referred to PoRCH to assess feasibility, develop the study budget, prepare compliance and regulatory items as well as consult on study design, recruitment, implementation, program evaluation and publication of research. The CRM may also be asked to work with the faculty to develop novel online and in-person courses relevant to the department’s missions.

Responsibilities to include:

- Manage clinical trials operations in administrative budgetary and fiscal matters in collaboration with the PoRCH leadership and the Office of Clinical Research. Plan and direct research activities for PoRCH including the management of resources to accomplish specified goals/objectives. Provide oversight of studies and teams for long and short-term projects: data entry and management, patient recruitment, IRB and billing compliance, and coordination of communication between study team and participants. Supervise the day-to-day operations of clinical trials including the supervision of the research support staff and research volunteers associated with PoRCH engaged in the delivery of research services and programs. Responsible for the ongoing workload assessment and reassignment of work as needed. Responsible for ensuring the research facilitated by the PoRCH is in compliance with university, state and federal regulations. Responsible for maintaining inclusive work environment that is free from discrimination and harassment.

- Manage clinical trials within the Pediatric Research Hub. Provide research support for faculty engaged in child-centered research. Direct project planning including feasibility, implementation and program evaluation. Encourage collaboration and provide research guidance and navigation.

- Lead team meetings as well as inter-departmental meetings to discuss project management issues; production of presentation materials to encapsulate current research and present options for future research; identify research opportunities relevant to health outcomes, quality improvement and/or health services research. Create and develop materials to support research development.

- Work with faculty to create and develop PI Initiated clinical trials. Develop regulatory tools, standard operating procedures and training materials. Write, edit, and submit IRBs for new projects, perform compliance reviews for current projects and ensure project deadlines are met.

- Completing tasks as assigned to complete clinical trial(s). Satisfying annual competencies as required by the University of Florida and Institutional Review boards. Participating in professional development and continuing education.

Expected Salary:

$75,000 - $85,000 annually; commensurate within this range based on qualifications and experience.

Minimum Requirements:

Master’s degree in appropriate area of specialization; or a bachelor’s degree in appropriate areas of specialization and two years of experience.

Preferred Qualifications:

  • Five years of experience in clinical trials or relevant human subjects research
  • Ph.D. in health related field
  • Clinical Research Professional Certification (CRPC) or able to qualify for CRPC
  • Good Clinical Practice (GCP) and IATA certified
  • Experience using OnCore and Epic
  • Experience working in a clinical setting
  • Experience working within UF’s clinical research system
  • Experience working in REDCap
  • Experience working in Electronic Data Capture (EDC) systems
  • Able to work collaboratively, forward ideas as appropriate and problem solve when needed.
    Multi-media capabilities strongly preferred; proficiency with Microsoft Office such as Word, PowerPoint and Excel.

Special Instructions to Applicants:

To be considered for this position, please upload your cover letter or letter of interest, resume, and a list of professional references.

Work schedule is Monday through Friday, 8:00 AM to 5:00 PM position. Hours may be adjusted to meet goals of the department. This job may require occasional overtime or weekends to meet programmatic needs.

The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

This is a time-limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:

Yes

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