Clinical Research Monitor (Part-Time)

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. 
• Review and track regulatory and pharmacy documentation; track subject screening and enrollment.
• 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.
• Familiarity with University of Arizona and Federal policies and procedures for protection of human subjects.
• Adept at Microsoft Products such as Word, Excel, and other Microsoft 365 programs.

FLSANon-ExemptFull Time/Part TimePart TimeNumber of Hours Worked per Week19Job FTE0.475Work CalendarFiscalJob CategoryResearchBenefits EligibleNo BenefitsRate of Pay$28.56 - $35.70Compensation Typehourly rateGrade8Compensation GuidanceThe Rate of Pay Field represents the University of Arizona’s good faith and reasonable estimate of the range of possible compensation at the time of posting. The University considers several factors when extending an offer, including but not limited to, the role and associated responsibilities, a candidate’s work experience, education/training, key skills, and internal equity.

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 and our .

Grade Range Minimum$28.56Grade Range Midpoint$35.70Grade Range Maximum$42.84Career Stream and LevelPC3Job FamilyResearch ComplJob FunctionResearchType of criminal background check required:Name-based criminal background check (non-security sensitive)Number of Vacancies1Target Hire Date5/17/2024Expected End DateContact Information for CandidatesAmy Selegue l aselegue@arizona.eduOpen Date4/18/2024Open Until FilledYesDocuments Needed to ApplyResume and Cover LetterSpecial Instructions to ApplicantApplication: The online application should be completed in its entirety.Diversity StatementAt the University of Arizona, we value our inclusive climate because we know that diversity in experiences and perspectives is vital to advancing innovation, critical thinking, solving complex problems, and creating an inclusive academic community. As a Hispanic-serving institution, we translate these values into action by seeking individuals who have experience and expertise working with diverse students, colleagues, and constituencies. Because we seek a workforce with a wide range of perspectives and experiences, we provide equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or genetic information. As an Employer of National Service, we also welcome alumni of AmeriCorps, Peace Corps, and other national service programs and others who will help us advance our Inclusive Excellence initiative aimed at creating a university that values student, staff and faculty engagement in addressing issues of diversity and inclusiveness.Notice of Availability of the Annual Security and Fire Safety ReportIn compliance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act (Clery Act), each year the University of Arizona releases an for each of the University’s campuses. These reports disclose information including Clery crime statistics for the previous three calendar years and policies, procedures, and programs the University uses to keep students and employees safe, including how to report crimes or other emergencies and resources for crime victims. As a campus with residential housing facilities, the Main Campus ASR also includes a combined Annual Fire Safety report with information on fire statistics and fire safety systems, policies, and procedures.
Paper copies of the Reports can be obtained by contacting the University Compliance Office at