Clinical Research Monitor - Tucson, United States - University of Arizona

University of Arizona

Verified Company

Tucson, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Part time

Description

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 endofstudy 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, patientfacing materials, checklists, and regulatory submissions.
Identify and address any studyrelated 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 sponsordesignated 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.
Highlevel of attention to detail.
Strong problemsolving 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

- $ $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