Manager of Clinical Research
Apply NowCompany: University of Florida
Location: Gainesville, FL 32608
Description:
Manager of Clinical Research
Job no: 535569
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration, Health Care Administration/Support
Department:29090900 - MD-PEDS-ENDOCRINOLOGY
Classification Title:
MGR, Clinical Research
Classification 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.
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 Prader-Willi 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 long-term program goals.
Responsibilities include:
Expected Salary:
$92,000 - $95,000 annually; commensurate with education and experience.
Required Qualifications:
Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.
Preferred:
EDUCATION & TRAINING: Master's degree in business administration field and/or Clinical Research Administration field; Graduate level certificates in Project Management and/or Regulatory Affairs.
EXPERIENCE: Minimum of five years of experience with research administration, sponsored programs oversight and regulatory protocols. Experience as a stakeholder with Federal and State agencies, and 10 years of experience with Industry-Sponsored protocols and Physician-Sponsored protocols, preferred. Experience with submissions to Food and Drug Administration; directing multi-site clinical trials, as well as regulatory and fiscal auditing oversight preferred.
KNOWLEDGE: Extensive knowledge of sponsored programs management, financial management, regulatory oversight, including FDA and GCP/ICH guidelines, clinical trial operations, and laboratory regulations as it pertains to the collection and processing of biological materials is expected. Knowledge of UFIRST, PeopleSoft, OnCore, SharePoint, myIRB, WCG Connexus, UFGO, UF RPP, PRS, I2B2, and EPIC systems are also preferred. Certification through ACRP or SoCRA preferred.
SKILLS: Project management and program oversight, personnel management, and interpersonal skills are a requirement of this position. Some laboratory and strong technical computer skills (Microsoft Word, Excel, Powerpoint, Outlook, Access, Teams, as well as Zoom, WebEx, GoogleDocs, GoogleSheets, various SFTPs, and SQL) are preferred. Problem solving skills are required.
ABILITIES: The ability to communicate with internal and external stakeholders in a manner that best serves the interest of the program, PI and team, in a professional manner that appropriately conveys the necessary tone and message. Must be able to advocate for the program and team. The ability to multitask and meet deadlines. The ability to work independently with little supervision is required. Must have the ability to manage 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 time-limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:Yes
Advertised: 17 Apr 2025 Eastern Daylight Time
Applications close: 23 Apr 2025 Eastern Daylight Time
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Job no: 535569
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Grant or Research Administration, Health Care Administration/Support
Department:29090900 - MD-PEDS-ENDOCRINOLOGY
Classification Title:
MGR, Clinical Research
Classification 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.
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 Prader-Willi 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 long-term 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:
$92,000 - $95,000 annually; commensurate with education and experience.
Required Qualifications:
Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.
Preferred:
EDUCATION & TRAINING: Master's degree in business administration field and/or Clinical Research Administration field; Graduate level certificates in Project Management and/or Regulatory Affairs.
EXPERIENCE: Minimum of five years of experience with research administration, sponsored programs oversight and regulatory protocols. Experience as a stakeholder with Federal and State agencies, and 10 years of experience with Industry-Sponsored protocols and Physician-Sponsored protocols, preferred. Experience with submissions to Food and Drug Administration; directing multi-site clinical trials, as well as regulatory and fiscal auditing oversight preferred.
KNOWLEDGE: Extensive knowledge of sponsored programs management, financial management, regulatory oversight, including FDA and GCP/ICH guidelines, clinical trial operations, and laboratory regulations as it pertains to the collection and processing of biological materials is expected. Knowledge of UFIRST, PeopleSoft, OnCore, SharePoint, myIRB, WCG Connexus, UFGO, UF RPP, PRS, I2B2, and EPIC systems are also preferred. Certification through ACRP or SoCRA preferred.
SKILLS: Project management and program oversight, personnel management, and interpersonal skills are a requirement of this position. Some laboratory and strong technical computer skills (Microsoft Word, Excel, Powerpoint, Outlook, Access, Teams, as well as Zoom, WebEx, GoogleDocs, GoogleSheets, various SFTPs, and SQL) are preferred. Problem solving skills are required.
ABILITIES: The ability to communicate with internal and external stakeholders in a manner that best serves the interest of the program, PI and team, in a professional manner that appropriately conveys the necessary tone and message. Must be able to advocate for the program and team. The ability to multitask and meet deadlines. The ability to work independently with little supervision is required. Must have the ability to manage 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 time-limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:Yes
Advertised: 17 Apr 2025 Eastern Daylight Time
Applications close: 23 Apr 2025 Eastern Daylight Time
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