Clinical Research Monitor

2 weeks ago

Tucson, United States University of Arizona Full time

**Posting Number**
- req19319**Department**
- Cancer Center Division**Department Website Link**

**Cancer Center Division**

**Location**
- University of Arizona Health Sciences**Address**
- 1515 N. Campbell Ave, Tucson, AZ 85724 USA**Position Highlights**

The University of Arizona Cancer Center Cancer Prevention Clinical Research Program (UACC CPre) is seeking a highly-motivated individual to provide dedicated monitoring support for clinical trials conducted by the UACC CPre and our affiliate organizations as per the CPre's oversight requirements as directed by the National Cancer Institute's (NCI) Cancer Prevention Clinical Trials Network (CP-CTNet). This position requires regular contact with investigators, regulatory staff, operations staff, and administrative staff. This individual will work as part of our team coordinating, maintaining, and performing clinical research monitoring and quality assurance duties. It is expected that the successful applicant will have knowledge regarding clinical research monitoring practices.

The University of Arizona has been recognized for our innovative work-life programs.

**Duties & Responsibilities**
- Conduct routine and end-of-study clinical site monitoring, ensuring compliance with the protocol, the NCI's Cancer Prevention Clinical Trials Network (CP-CTNet) guidelines, the Code of Federal Regulations/International Conference of Harmonisation/Good Clinical Practices (CFR/ICH/GCP) guidelines, local regulations and applicable Standard Operating Procedures (SOPs).
- Perform Quality Assurance (QA) duties on study materials such as source documents, patient-facing materials, checklists, and regulatory submissions.
- Identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting, and protocol deviations or violations.
- Maintain a thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
- Conduct routine internal monitoring of Lead Academic Organization (LAO) CP-CTNet trial activities.
- Review source documents and case report forms for clarity, consistency and accuracy.
- Prepare and/or modify monitoring documents.
- Maintain open, effective communication with study staff, Principal Investigator (PI), and leadership at UA as well as staff at Affiliate Organizations (AO), CP-CTNet, and sponsor-designated data coordinating center.
- Communicate with site staff to ensure adherence to protocol and regulatory guidelines and resolve problems in a timely manner.
- Actively participate in team meetings.
- Attend and participate in site initiation visits for CPre CP-CTNet trials.
- Provide support to AO staff preparing for external audits, as needed.
- Other duties as assigned.

Knowledge, Skills, and Abilities:

- Demonstrated strong interpersonal and communication skills.
- Excellent technical writing skills.
- Adept at learning new software programs/databases.
- Excellent time management and organizational skills.
- High-level of attention to detail.
- Strong problem-solving skills.
- Ability to manage multiple priorities, projects, and tasks.
- A strong work ethic and a high degree of reliability and ability to meet deadlines.
- Ability to resolve issues independently.

**Minimum Qualifications**
- Bachelor's degree or equivalent advanced learning attained through professional level experience required.
- Minimum of 5 years of relevant work experience in clinical trials monitoring required, or equivalent combination of education and work experience.

**Preferred Qualifications**
- Experience in clinical trial quality assurance, workflows, monitoring processes and procedures.
- Previous experience with national cooperative group and private industry cancer clinical research.
- Knowledge of medical oncology terminology and treatment concepts.
- Adept at Microsoft Products such as Word, Excel, and other Microsoft 365 programs.

**FLSA**
- Non-Exempt**Full Time/Part Time**
- Part Time**Number of Hours Worked per Week**
- 19**Job FTE**
- 0.475**Work Calendar**
- Fiscal**Job Category**
- Research**Benefits Eligible**
- No Benefits**Rate of Pay**
- $28.56 - $35.70**Compensation Type**
- hourly rate**Grade**
- 8**Compensation Guidance**
- The **Grade Range Minimum, Midpoint, and Maximum Fields** listed below represent a full range of career compensation growth over time in this position and grade. Each unit typically sets starting pay between minimum and midpoint upon hire. The university offers compensation growth opportunities within its career architecture. To learn more about compensation, please review our Applicant Compensation Guide and our Total Rewards Calculator.**Grade Range Minimum**
- $28.56**Grade Range Midpoint**
- $35.70**Grade Range Maximum**
- $42.84**Career Stream and Level**
- PC3**Job Family**
- Research Compl**Job Function**
- Research**Type of criminal background check required**:

- Name-based criminal background check (non-

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