Program Director, Early Phase

Updated: 2 months ago
Location: Kansas City, KANSAS
Job Type: FullTime

Department:
SOM KC Cancer Center Clinical Trials

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Clinical Research
Position Title:
Program Director, Early Phase
Job Family Group:
Professional Staff
Job Description Summary:
Manages and coordinates a major program or set of programs established to address a key area of specialized need within the University and the community. Provides advanced professional/technical leadership, consultation, and expertise within the program's area of focus, as well as day-to-day administrative and functional management of the program's activities and staff. Sets strategic direction, develops and implements work scope and related operational policies and procedures; establishes funding, and provides operational planning, budgeting, and assessment. Programs/projects managed are of key operational impact, both within and external to the University, and are typically revenue-generating and/or grant-funded from a major funding source or series of funding sources.
Job Description:

This position reports to the Senior Director, Clinical Trials Office and is responsible for the execution and oversight of clinical trial operations and clinical research coordinator conduct for all Early Phase clinical trials from initiation through to closeout. The Program Director ensures that all clinical and departmental operations are conducted according to the mission of the Cancer Center to achieve excellence in clinical activities in the delivery of patient care and services. 

The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Join our clinical trials team where you can make a difference!
The starting salary is between the minimum and midpoint of the salary range listed.




Required Qualifications:

  • Education: Bachelor’s degree in life sciences or related field. Nursing degree (BSN or advanced level degree) associate degree or non-nursing may be considered with significant clinical expertise.

  • Work Experience: Minimum of 5 years clinical trial experience within the pharmaceutical industry or academia. Knowledge of FDA regulations and GCP-ICH guidelines. Experience managing a staff and working with physicians on clinical trials.

  • Skills: Excellent written and oral communication skills. Demonstrated ability to work independently and collaboratively. Must be detail oriented and able to multi-task managing multiple and competing priorities. Possess excellent organizational skills. Have a thorough understanding of Clinical research study start up process. Working knowledge of clinical research databases and software for managing projects and resources.  Proficiency in PC operations and software applications such as MS Outlook, Windows, Excel and Word. Experience with Electronic Medical Record charting.  Exhibit understanding of the impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.  Demonstrate the use of sensitivity, tact and good judgment in communicating with physicians, clinical trials and health system personnel and patients. This position will have daily interaction with clinical research staff, investigators, patients and clinic staff; therefore, candidate must demonstrate strong interpersonal/customer service skills. Must be proficient in medical terminology.  


Preferred Qualifications:

  • Education: Master’s Degree

  • Skills: Research certification preferred such as Socra certification or certification eligible: Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible Collaborative Institutional Training Initiative (CITI) training certification or certification eligible. Ability to read, speak and write Spanish preferred.

    Experience with Clinical Trials Management Systems.

Job Duties Outlined:

  • Perform functional management duties of up to but not limited to 6 direct reports.

  • 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 goal 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. Communicate project findings and priorities.

  • Provide project support and manage cross-functional team members. Prepare agenda, manage and facilitate assigned Disease Working Group (DWG) meetings. Aid 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. Accomplish project goals through effective team leadership.

  • 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.
  • Other duties as assigned.

Required Documents:

  • Resume/CV AND Cover Letter


Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A14
Pay Range:

Minimum

74688

Midpoint

97509

Maximum

119812

Department:
SOM KC Cancer Center Clinical Trials

-----

Clinical Research
Position Title:
Program Director, Early Phase
Job Family Group:
Professional Staff
Job Description Summary:
Manages and coordinates a major program or set of programs established to address a key area of specialized need within the University and the community. Provides advanced professional/technical leadership, consultation, and expertise within the program's area of focus, as well as day-to-day administrative and functional management of the program's activities and staff. Sets strategic direction, develops and implements work scope and related operational policies and procedures; establishes funding, and provides operational planning, budgeting, and assessment. Programs/projects managed are of key operational impact, both within and external to the University, and are typically revenue-generating and/or grant-funded from a major funding source or series of funding sources.
Job Description:

This position reports to the Senior Director, Clinical Trials Office and is responsible for the execution and oversight of clinical trial operations and clinical research coordinator conduct for all Early Phase clinical trials from initiation through to closeout. The Program Director ensures that all clinical and departmental operations are conducted according to the mission of the Cancer Center to achieve excellence in clinical activities in the delivery of patient care and services. 

The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Join our clinical trials team where you can make a difference!
The starting salary is between the minimum and midpoint of the salary range listed.




Required Qualifications:

  • Education: Bachelor’s degree in life sciences or related field. Nursing degree (BSN or advanced level degree) associate degree or non-nursing may be considered with significant clinical expertise.

  • Work Experience: Minimum of 5 years clinical trial experience within the pharmaceutical industry or academia. Knowledge of FDA regulations and GCP-ICH guidelines. Experience managing a staff and working with physicians on clinical trials.

  • Skills: Excellent written and oral communication skills. Demonstrated ability to work independently and collaboratively. Must be detail oriented and able to multi-task managing multiple and competing priorities. Possess excellent organizational skills. Have a thorough understanding of Clinical research study start up process. Working knowledge of clinical research databases and software for managing projects and resources.  Proficiency in PC operations and software applications such as MS Outlook, Windows, Excel and Word. Experience with Electronic Medical Record charting.  Exhibit understanding of the impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.  Demonstrate the use of sensitivity, tact and good judgment in communicating with physicians, clinical trials and health system personnel and patients. This position will have daily interaction with clinical research staff, investigators, patients and clinic staff; therefore, candidate must demonstrate strong interpersonal/customer service skills. Must be proficient in medical terminology.  


Preferred Qualifications:

  • Education: Master’s Degree

  • Skills: Research certification preferred such as Socra certification or certification eligible: Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP) or certification eligible Collaborative Institutional Training Initiative (CITI) training certification or certification eligible. Ability to read, speak and write Spanish preferred.

    Experience with Clinical Trials Management Systems.

Job Duties Outlined:

  • Perform functional management duties of up to but not limited to 6 direct reports.

  • 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 goal 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. Communicate project findings and priorities.

  • Provide project support and manage cross-functional team members. Prepare agenda, manage and facilitate assigned Disease Working Group (DWG) meetings. Aid 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. Accomplish project goals through effective team leadership.

  • 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.
  • Other duties as assigned.

Required Documents:

  • Resume/CV AND Cover Letter


Employee Type:
Regular
Time Type:
Full time
Pay Rate Type:
Salary
Pay Grade:
A14
Pay Range:

Minimum

74688

Midpoint

97509

Maximum

119812
View or Apply

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