Skip to Main Content

Clinical Site Manager

Posting Details

Position Information

Working Title Clinical Site Manager
Classification Title Program Manager
Position Number M0203871
Hours Per Week 40.000
Department CCC-KU Cancer Ctr-Admin.
Campus Location Kansas City Metro
Student Position
Position Summary

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors, and other duties as assigned assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, KUCC Policy and Procedure and research protocols.

Required Qualifications

• Bachelor’s degree or equivalent experience in life sciences or related field
• Knowledge of FDA regulations relevant to drugs, devices, biologics
• Attention to detail with excellent analytical and problem-solving skills
• Ability to work effectively under periodic stressful conditions
• Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology
• Ability to manage multiple tasks and set priorities and meet deadlines
• Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment
• Excellent organizational and communication skills
• Computer literate including Microsoft Word, Excel, Access, CTMS, and EDC systems.
• Familiarity with clinical management database systems utilizing tables, queries, etc.
• Travel required to monitor multi-site IITs and attend national meetings.
• Off-site travel is variable, but could be 5% – 20%.

Preferred Qualifications

• Previous working knowledge and experience with the FDA and Pharmaceutical sponsors
• 5 or more years clinical research experience

Environment Office
Physical Requirements Light
Probation Status

Subject to the regulations of the State of Kansas, the Board of Regents and the University of Kansas Medical Center, I understand and agree that I may be subject to a probation period and during the probation period I serve at the pleasure of the Executive Vice Chancellor of KUMC and my employment may be ended at any time during that period.

Hiring Range
EEO Statement

KU Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.

Job Duties

Description of Job Duty

Conduct internal and external, as appropriate, monitoring for all investigator-initiated protocols managed by the Clinical Trials Office. This includes remote and risk-based monitoring.

Description of Job Duty

Conduct high level review of all clinical trials managed by the Clinical Trials Office, including cooperative groups, community sites, and industry-sponsored.

Description of Job Duty

Be knowledgeable, stay current, and act accordingly within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the clinical research industry. Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures as assigned by Director.

Description of Job Duty

Act as a Quality Assurance resource to clients of the Clinical Trials Office, evaluate problems and provide solutions.

Description of Job Duty

Promote a positive work environment that is maintained through open and effective communication.

Description of Job Duty

Establish and foster strong relationships and efficient interactions with KU Cancer Center investigators, KUCC study coordinators, the KUMC community, outside site personnel and sponsors.

Description of Job Duty

Ensure quality of deliverables for projects of assigned investigators/clients.

Description of Job Duty

Identify project issues and suggests possible solutions; manage problem resolution through expedient and corrective means.

Description of Job Duty

Remote and On-Site Monitoring Responsibilities and Assessment of Site Performance
a. Ensure study staff who will conduct the protocol have received proper materials and instructions to safely enter patients into the study
b. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
c. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data. Ensure timely distribution of monitoring visit reports and any supplemental documents/reports to all sites as part of our contribution to the expeditious completion of the study procedures and data collection as well as building and maintaining relationships between sites and KUCC
d. Ensure the resources of the funder and KUCC are spent wisely by performing the required monitoring tasks in an efficient manner according to established SOPs and guidelines
e. When traveling will adhere to all applicable policies and guidelines of KUCC including managing travel expenses in an economical fashion and preparing accurate and timely trip reports

Description of Job Duty

Perform Case Report Form Review
Review case report form, query generation and resolution against established monitoring plan guidelines, with or without direct supervision, on KUCC data management systems.

Description of Job Duty

Assist with Administration of Clinical Research Projects (Multi-Site IITs)
a. Assist in recruitment/review of investigators, collecting investigator documentation and site management
b. Update, track and maintain study-specific trial management tools/systems
c. Generate and track drug shipments and supplies as needed
d. Attend investigator meetings, project team meetings and teleconferences as needed
e. Coordinate slot allocation/randomization of study patients across all sites, providing timely study updates as needed to all applicable site personnel.
f. Develop materials (slides, reports, charts, etc.) for multi-site teleconferences and dose-escalation calls as needed to provide relevant details to all interested parties.
g. Assist with site/study audit preparation and follow up on Corrective Action Plan responses as needed

Description of Job Duty

Provide Coverage for Clinical Contact
a. Assist project team in clinical coverage via telephone, email, or in-person as required for Multi-Site IITs.
b. Perform other duties as assigned by management

Description of Job Duty

Other duties as assigned.

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this posting?
    • KU Medical Center Website
    • KansasWorks
    • Career Builder
    • Monster
    • Indeed
    • NonProfit Connect
    • Higher Ed Jobs
    • LinkedIn
    • Facebook
    • Twitter
    • University Career Services Page
    • Print or online publication ad
    • Job/field-specific organization website
    • Referred by current/former employee
    • PracticeLink
    • Health eCareers
    • Other - please specify below

Documents Needed To Apply

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter