Temp On-Site Research Quality & Compliance Coordinator

Arizona Liver Health; Tucson (AZ); On-site; USD 48,000 - 55,000; Full time

Benefits offered by this job

Accrued Sick Time

Job summary

Arizona Liver Health (ALH) is seeking an experienced TEMPORARY - Research Quality Compliance Coordinator (QC) in Peoria, Tucson or Chandler, AZ with a background in Clinical Research, Quality Compliance, and / or Regulatory Operations. As a key member of our team, you will play a crucial role in ensuring the highest standards of scientific excellence. Start date September 21st.

$35 per hour. Full-time, 3-Month Contract (eligible for overtime). Onsite schedule, Mon-Fri 8am-5pm.

Qualifications

• Associates or Bachelor's degree in healthcare, clinical research management, or related required.
• Experience with GCP, SOPs, CAPA and regulatory processes.
• Ability to work independently in a fast-paced environment with attention to detail.

Responsibilities

• Ensure high integrity of data and patient safety at the research site through quality assurance review and management of the conduct of clinical research activities.
• Conduct routine data quality assurance checks.
• Review data for deviations, errors, omissions, or inconsistencies.
• Ensure studies are being conducted according to the applicable site SOPs.
• Work with the research staff and Principal Investigator to ensure identified issues are addressed in a timely and appropriate manner.
• Complete and review CAPAs as needed. Review CAPAs implementation as needed.
• Work with clinic staff to address any audit findings from outside auditors (sponsor, CRO, IRB or FDA inspection findings).
• Ensure all required documentation is complete and appropriately filed.
• Liaison with study sponsors to resolve questions and/or concerns as needed.
• Work with CRC to ensure understanding or required consistencies between source and EDC.
• Help in training research staff regarding QC (as designated).
• Meet with CRA at monitoring visits regarding findings. Engage other research staff as needed.

Skills

GCP knowledge

SOP development

CAPA experience

Regulatory compliance

Data integrity

CTMS/EMR

Detail oriented

Team collaboration

Education

Associates or Bachelor's degree in healthcare, clinical research management, or related

Tools

Microsoft Office

CTMS/EMR software

Job description

Arizona Liver Health (ALH) is seeking an experienced TEMPORARY - Research Quality Compliance Coordinator (QC) in Peoria, Tucson or Chandler, AZ with a background in Clinical Research, Quality Compliance, and / or Regulatory Operations. As a key member of our team, you will play a crucial role in ensuring the highest standards of scientific excellence. Start date September 21st.

$35 per hour. Full-time, 3-Month Contract (eligible for overtime). Onsite schedule, Mon-Fri 8am-5pm.