Job description

The Stephenson Cancer Center at the University of Oklahoma is the Oklahoma's only National Cancer Institute-Designated Cancer Center, the highest national accreditation for outstanding patient care and research. The Stephenson Cancer Center is the largest oncology practice in the state, with more than 70 board-certified oncology physicians and a large team of advanced providers and supportive care specialists delivering the highest standard of patient-centered, multidisciplinary care for every type of cancer. The Stephenson Cancer Center currently ranks number one among all cancer centers in the nation for the number of patients participating in NCI-sponsored treatment trials, and it is one of only 30 lead centers in the NCI’s National Clinical Trials Network.

The Stephenson Cancer Center is Oklahoma’s leading cancer research organization, with 120 research scientists working to eliminate cancer through conducting innovative basic, clinical and population-based research. These researchers are supported by more than $60 million in annual grant funding from the National Institutes of Health and other sponsors. With a legislatively mandated mission to provide statewide leadership in addressing Oklahoma’s cancer burden, the Stephenson Cancer Center supports numerous outreach, education and screening programs in partnership with the Oklahoma Tobacco Settlement Endowment Trust, the American Cancer Society, the Susan G. Komen Foundation and Oklahoma’s Tribal Nations among many other aligned organizations.

At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The Clinical Trials Compliance Specialist, under direct supervision, performs auditing of site-specific and affiliate clinical trials and investigator-initiated studies and monitors protocol compliance.

Responsibilities:

• Performs routine auditing of site‐specific and affiliate clinical trials in compliance with federal, sponsor, and internal guidelines.
• Monitors for protocol compliance to include but not limited to dosing, study procedures, assessment entries, and study patient documents to identify protocol non‐compliance.
• Advises supervisor of any protocol deviations.
• Performs auditing of investigator‐initiated studies to determine if the study is in compliance with the Code of Federal Regulations (CFR) guidelines and internal standard operating policies and procedures.
• Performs routine and systematic internal audits of studies in preparation for the enhancement of data quality and in preparation of an external audit.
• May assist with training and preparing staff for National Cancer Institute (NCI) and Food and Drug Administration (FDA) audits.
• Assists with compiling data and preparing study‐specific reports of audit findings.
• Performs related duties as assigned to successfully fulfill the functions of the position.

Required Education: High School Diploma

Required Experience: 12 months working in a clinic or with clinical trials experience

Skills:

• Basic knowledge of CFR guidelines and standard operating policies and procedures
• Must be able to develop and maintain constructive and cooperative working relationships with staff and outside entities
• Proficiency with Microsoft Office Suite, particularly Word and Outlook
• Ability to recognize protocol problems and discuss with supervisor
• Abilitity to work as a team player
• Ability to communicate verbally and in writing

Working Conditions:

Physical: Must be able to sit for prolonged periods of time. Reaching, bending, and speaking.
Manual dexterity.

Environmental: Standard office environment

For more information, visit our website at www.jobs.ou.edu. If you would like to apply, the application must be completed on OUHSC’s job site. The listing for this position is job number 222321 – Clinical Trials Compliance Specialist

The University if an equal opportunity institution. www.ou.edu/eoo

Job Type: Full-time

Pay: $34,400.00 - $43,800.00 per year

Benefits:

• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Oklahoma City, OK 73104: Reliably commute or planning to relocate before starting work (Required)

Education:

• High school or equivalent (Required)

Experience:

• working in a clinic or with clinical trials: 1 year (Required)

Work Location: One location

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