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You will be updated with latest job alerts via email$ 83000 - 131000
1 Vacancy
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Clinical Trials Clinical Trials OperationsJob Duties Outlined
Perform functional management duties of a clinical program portfolio as assigned by leadership.
Primary contact for all protocol clarifications and logistical project related concerns.
Develop direct reports through initial on-board training regular 1:1 mentoring and coaching career path management leave requests continuing education and delegation of responsibility.
Communicate effectively laterally across the team as well as up and down reporting structures within the Clinical Trials Office (CTO).
Motivate the project team to commit to a common purpose performance goals and approach for which all hold themselves individually and mutually accountable. Manage contractual and organizational client expectations.
Balance workloads ensure tracking systems are up to date assist team members with prioritization problem solving and resourcing. Delegate activities while retaining ownership. Liaise with CTO management to optimize performance of project team members.
Provide project support and manage cross-functional team members. Prepares agenda manages and facilitates assigned Disease Working Group (DWG) meetings. Aids in study budget preparation and resource planning to accomplish study objectives.
Manage team study pipeline and prepare and present prospective trials to the Executive Review Committee (ERC). Actively participate in Project Director Departmental Coordinator Team and Staff meetings.
Support upper management through the use of effective tracking tools to provide consistent and accurate project status. Participate in Ad hoc projects as assigned.
Assist Sponsor with scheduling of monitoring visits: Site Initiation Visit Interim Monitoring Visit and Close Out Visit. Promote project continuity by facilitating the internal kick-off meeting (KOM) and other training as required by protocol updates.
Develop review and update policies procedures process improvement training and evaluations that help support clinic workflows productivity quality improvement and customer service.
Triage and resolve clinical research and data concerns issues. Escalate to senior leaders as appropriate.
Contribute to division program resource planning to accomplish institutional objectives. Interface with Cancer Center finance team for coverage analysis process and financial feasibility for each study.
Collaborate with other directors and managers and health system departments.
Develop or review study management plans as needed. Ensure compliance with study tools training materials as well as institutional standard processes policies and procedures
Maintain proficiency in workflows of clinic Epic/Beacon and any other systems required for scheduling screening and treating new clinical trial patients.
Assist leadership in the development of Standard Operating Procedures and Working Practice Guidelines related to clinical trial referral process.
Document all communication (i.e. telephone and other) with patients per University and Health System policies.
Attend study specific safety calls and provide updates on clinical trial participants.
This job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job not an exhaustive list of all possible job responsibilities tasks duties and assignments. Furthermore job duties responsibilities and activities may change at any time with or without notice
Required Qualifications
Certifications: One of the following:
Certified Clinical Research Coordinator (CCRC).
Certified Clinical Research Professional (CCRP).
Work Experience:
9 years clinical trial experience within the pharmaceutical industry or academia. Education may substitute for experience on a year for year basis.
Experience with FDA regulations and ICH-GCP guidelines.
Prior experience managing a staff and working with physicians on clinical trials.
Experience with study budgets contracts and grant applications.
Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
Experience with medical terminology and investigative scientific methods.
Experience with clinical research databases and software for managing projects and resources.
Experience with Electronic Medical Record charting.
Preferred Qualifications
Education:Bachelors degree.
Work Experience:
Experience with Clinical Trials Management Systems.
Skills
Communication.
Collaboration.
Attention to detail.
Time management.
Organization.
Computer skills.
Interpersonal skills.
If selected as a final candidate for this position you may be required to complete the Association of American of Universities Representations and Warranties document and sign a release of records that will allow the University of Kansas Medical Center to conduct a further background check with former employers. A copy of the Representations and Warranties document can be found here.
Comprehensive Benefits Package:
Coverage begins on day one for health dental and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance long-term disability insurance and various additional voluntary insurance plans are available. Paid time off including vacation and sick begins accruing upon hire plus ten paid holidays. One paid discretionary day is available after six months of employment and paid time off for bereavement jury duty military service and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. Type: Regular Compensation Statement: The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including but not limited to education experience and training qualifications relative to the requirements of the position and funding. At the University of Kansas Medical Center a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range taking into account the combination of factors listed above. Minimum Midpoint MaximumTime Type:
Full timeRate Type:
SalaryPay Range:
$83000.00 - $131000.00
Required Experience:
Director
Full-Time