Kansas Works Veterans Jobs

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13133331

r

rClinical Research Monitor - Research Administration

r

r

Department:

RI Office of Clinical Trials Administration (OCTA)

-----

OCTA Investigator Support Program

Position Title:

Clinical Research Monitor - Research Administration

Job Family Group:

Professional Staff

Job Description Summary:

Responsible for study site monitoring including routine monitoring visits, pre-study and site-initiation visits and study close-out for clinical research at KUMC.

The position requires an individual with exceptional communication skills to work collegially with members of the research community to ensure compliance.

Job Description:

Key Roles and Responsibilities:

• Conduct monitoring visits, internal and external, for KUMC investigator-initiated trials. This includes onsite and remote monitoring of single and multi-site studies.
• Collaborate with Principal Investigator/Sponsor in development of study monitoring plan.
• Work with study teams prior to study activation to develop and/or review core study documents such as Case Report Forms (CRFs)
• Ensure study sites receive proper materials, instructions, and training to conduct the study.
• Ensure study is conducted, recorded, and reported in accordance with the protocol, applicable SOPs, Good Clinical Practices, and the applicable regulatory requirements. This includes verifying the informed consent process and protocol requirements are met for study participants.
• Source verify data collected on data collection tools or case report forms (CRFs), generate queries as necessary and confirm resolution.

Multi-Site Study Management

• Support the maintenance of the trial master file by collecting appropriate regulatory documents from all sites Attend study meetings and teleconferences.
• Assist project team in study coverage via telephone or email for multi-site IITs.
• Travel to attend national meetings, host external audits, perform external monitoring, etc.

Required Qualifications:

Education

• Bachelor\'s degree in a healthcare discipline, biological sciences, or related field or an equivalent combination of education and relevant work experience on a year for year basis.

Work Experience

• Two (2) or more years of related work experience
• Experience with federal regulations governing human subjects\' research.
• Working knowledge of basic scientific methods, biological principles and medical terminology.
• High-level of organizational and analytical skills and demonstrated ability to work collegially in a complex process-oriented environment.
• Proficiency in computer software, systems, and programs.
• Excellent written and verbal communication skills as evidenced by application materials.
• Ability to manage multiple tasks and set priorities and meet deadlines.
• Familiarity with clinical management database systems utilizing tables, queries, etc.

Preferred Qualifications:

Work Experience

• Experience in clinical research monitoring including multi-site studies.
• Prior research experience in an academic setting.

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 Documents:

Resume/CV

Cover Le ter

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. https://www.kumc.edu/human-resources/benefits.html{rel="noopener noreferrer" target="_blank"}

Employee Type:

Regular

Time Type:

Full time

Rate Type:

Salary

Compensation Statement:

The pay range listed for this pos