drjobs Manager of Clinical Research

Manager of Clinical Research

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1 Vacancy
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Job Location drjobs

Gainesville, FL - USA

Yearly Salary drjobs

$ 92000 - 95000

Vacancy

1 Vacancy

Job Description

Classification Title:

MGR Clinical Research

Classification Minimum Requirements:

Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience.

Job Description:

The Manager of Clinical Research will manage the UF Prader Willi Syndrome Genetic and Hypothalamic Obesity research program. The successful incumbent will oversee the Clinical Trials and Translational Research Activities of the PraderWilli syndrome and early childhood translational research program including implementation of the necessary policies and procedures for program development as required.

The incumbent will work with program director to develop a strategic plan for the program to conduct all intended clinical trials and research initiatives including short term and longterm program goals.

Responsibilities include:

  • Identification and implementation of actions needed to pursue those program goals
  • Supervision and mentoring of all PWSGHOR staff members; management of all financial aspects of the program including accounts receivable accounts payable and the allocation of clinical trial funds and foundation funds for operating costs and expenses the negotiation of clinical trial budgets
  • Providing operational support for all clinical trials conducted in the program to supplement team member workload and staffing changes
  • Development of Standard Operating Procedures for the program
  • Performing internal audits and preparation for hosting of and response to external audits and inspections
  • Communications with all internal and external stakeholders
  • Database development to better manage the operations of the PWS/GO/HO clinical practice and to facilitate potential QI initiatives in the future.
Expected Salary:

$92000 $95000 annually; commensurate with education and experience.

Required Qualifications:

Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience.

Preferred:
EDUCATION & TRAINING: Masters degree in business administration field and/or Clinical ResearchAdministration field; Graduate level certificates in Project Management and/or Regulatory Affairs.
EXPERIENCE: Minimum of five years of experience with research administration sponsored programsoversight and regulatory protocols. Experience as a stakeholder with Federal and State agencies and 10years of experience with IndustrySponsored protocols and PhysicianSponsored protocols with submissions to Food and Drug Administration; directing multisite clinical trials as well asregulatory and fiscal auditing oversight preferred.
KNOWLEDGE: Extensive knowledge of sponsored programs management financial managementregulatory oversight including FDA and GCP/ICH guidelines clinical trial operations and laboratoryregulations as it pertains to the collection and processing of biological materials is expected. Knowledge ofUFIRST PeopleSoft OnCore SharePoint myIRB WCG Connexus UFGO UF RPP PRS I2B2 andEPIC systems are also preferred. Certification through ACRP or SoCRA preferred.
SKILLS: Project management and program oversight personnel management and interpersonal skills area requirement of this position. Some laboratory and strong technical computer skills (Microsoft Word ExcelPowerpoint Outlook Access Teams as well as Zoom WebEx GoogleDocs GoogleSheets variousSFTPs and SQL) are preferred. Problem solving skills are required.
ABILITIES: The ability to communicate with internal and external stakeholders in a manner that best servesthe interest of the program PI and team in a professional manner that appropriately conveys the necessarytone and message. Must be able to advocate for the program and team. The ability to multitask and meetdeadlines. The ability to work independently with little supervision is required. Must have the ability tomanage other personnel. Must be able to learn new electronic systems/platforms quickly.
Special Instructions to Applicants:

In order to be considered you must upload your cover letter and resume.

This is a timelimited position.

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

Health Assessment Required:Yes


Required Experience:

Manager

Employment Type

Full-Time

Company Industry

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