Core Committees Manager University of Florida, UF Health Cancer Center United States

Core Committees Manager - UF Health Cancer Center


JOB NO:
507243

 

WORK TYPE:
Staff Full-Time

 

LOCATION:
Main Campus (Gainesville, FL)

 

CATEGORIES:
Research/Scientific/Grants

 

DEPARTMENT:
29300500 - MD-CANCER CTR CLINICAL TRIALS

 

Classification Title:

Manager, Clinical Research

 

Job Description:

Directly supervises assigned staff, including but not limited to the Scientific Review and Monitoring Committee (SRMC) Coordinator and a Reporting Coordinator. Ensures success of the unit by monitoring staff productivity, establishing performance goals, and training or coaching staff as needed. Approves bi-weekly time reporting. In conjunction with the Associate Director and Human Resources, participates in the recruitment and onboarding of new staff and in staff performance appraisals.

 

Establishes and manages a written system of standard operating policies, procedures and guidelines for the conduct of research that are in alignment with UFHCC policies and procedures, NCI requirements, external regulatory agencies and central research administration offices. Interprets and ensures proper execution of institutional policies and recommends policy changes as necessary.

 

Serves as a regulatory liaison with institutional, local, state and federal external agencies, communicating directly with agency personnel as necessary.

 

Directs internal audits of all required UHFCC committee functions; manages committee memberships and attends committee meetings as required. Performs evaluations of committee metrics and reports committee performance to UFHCC and CRO leadership on a regular basis.

 

Responsible for overall management of related center or group meetings, as well as meetings of applicable scientific advisory councils.

 

Participates in the evaluation of research industry best practices for research compliance and quality assurance to develop metrics that drive improvement. Serves as research team liaison, providing communication and consultation services as needed. Maintains records, files and data for research regulatory and quality assurance efforts.


Implements continuous process improvement across all trial types. Process improvement initiatives can be related to but are not limited to: trial implementation flow, timing of trial implementation, coordination of staff tasking and workload analysis, streamlined project assignment and delegation procedures, creation of staff accountability and performance evaluation through process improvement. Results of process improvement should be well documented and disseminated to CRO staff and vested institutional stakeholders through standard operating procedures.

 

Clinical research committee coordination responsibilities include creating meeting agendas, developing complex correspondence to Principal Investigators (PIs), conducting follow-up activity on action items in a timely manner, outreaching to PIs and clinical research coordinators for research accrual information, and writing complex meeting minutes for scientific meeting deliberations. The individual must verify the accuracy of clinical trial information in the clinical trial management system, OnCore, and adhere to both institutional policies and National Cancer Institute requirements.

 

Plans study specific DISC audit deadlines, develops action plans for delinquent or inadequate audit responses and archives audit reports generated as part of the DSMB review process. This includes setting up the audits, notifying appropriate personnel of the pending audits, assisting with audits, and reporting the results back to the stakeholders including the IND holder (if applicable), the PI, the study staff and the DSMB Committee.

 

Maintains, records and prepares correspondence relating to major revisions/adverse events/unanticipated problems reviewed by the DISC. Advises the study team as to the DISC Chair's review comments for incorporation into IRB submissions.

 

Clinical research committee coordination responsibilities include creating meeting agendas, developing complex correspondence to Principal Investigators (PIs), conducting follow-up activity on action items in a timely manner, outreaching to PIs and clinical research coordinators for research accrual information, and writing complex meeting minutes for scientific meeting deliberations. Ensures correspondence from DSG meetings has been archived appropriately. The individual must verify the accuracy of clinical trial information in the clinical trial management system, OnCore, and adhere to both institutional policies and National Cancer Institute requirements. Provides monthly performance metrics to the DSGs.

 

Supervises the SRMC Coordinator staff position and provides additional support to the SRMC committee as needed. Responsibilities may include: creating SRMC meeting agendas, developing correspondence to Principal Investigators (PIs), outreach to PIs and clinical research coordinators for research accrual information, and writing complex meeting minutes for scientific meeting deliberations. Responsible for pre-reviews of proposals prior to submission to committee members.

 

This individual must verify the accuracy of clinical trial information in the clinical trial management system, OnCore, and adhere to both institutional policies and National Cancer Institute requirements. Ensures that all initial and recurring reviews of protocols are completed in a timely fashion. Assists committee members with determining whether studies are meeting accrual expectations and criteria for renewal.

 

Serves as a liaison between the CRO and its partnering departments, sites, and other agencies. Maintains regular contact and exchange of information with partners and other external entities in order to fulfill the clinical and research obligations of the CRO. Develops and maintains other relationships as warranted to benefit the CRO. Serves on taskforces for special projects for the CRO.

 

Acts as liaison with members of internal and external advisory councils and reports on progress of the center or group. Available to and/or provides education and awareness of these system processes to stakeholders in and outside the institution as requested by UFHCC leadership.


Accurately and professionally identifies education issues affecting scientific committee operations to ensure that education, inservices and trainings are completed in a timely manner.

 

Advertised Salary:

Annual salary range is $68,000 to $75,000; commensurate with education 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:

Master’s degree

Research certification (ACRP or SoCRA)

Six years of experience in clinical research operations

Experience interacting with DSMB and PRMC committees at an NCI designated center

Experience working with a clinical trials management system

Experience with Excel, PowerPoint, Word and biostatistical principles

Ability to work independently, interact professionally and possess effective writing and organizational skills

Supervisory experience

 

Special Instructions to Applicants:

Applicants must upload a copy of the following documents to be considered for this position:

Cover Letter or Letter of Interest
Curriculum Vitae or Résumé
List of Three References
This is a time limited position.

 

The University of Florida is an equal Opportunity Employer dedicated to building a broadly diverse and inclusive faculty and staff.

 

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

 

Health Assessment Required:

No

 

ADVERTISED:
03 May 2018 Eastern Daylight Time


APPLICATIONS CLOSE:
01 Jun 2018 Eastern Daylight Time


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