TEMPORARY - Research Quality Compliance Coordinator (QC)

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

About Us

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

About Us

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

Role 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.

Title:

TEMPORARY -- Research Quality Compliance Coordinator (QC) (Peoria, Tucson or Chandler, AZ)

Compensation:

$35 per hour

Status:

Full-time, 3-Month Contract (eligible for overtime)

Work Schedule:

Monday-Friday, 8am-5pm, Onsite

Start date:

September 21st

2 openings

Essential Job Functions/duties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• 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 (regulatory coordinator, site manager, Director of Clinical Research).

Knowledge/Skills/Abilities Required

• A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
• Experience developing, managing, and reviewing Standard Operating Procedures (SOPs).
• Understanding of and experience in developing and supporting Corrective and Preventative Action Plans (CAPA).
• Ability to work independently, and in a fast-paced environment
• Attention to detail in all aspects of work
• Excellent collaboration skills
• Ability to work independently as well as in teams
• Excellent verbal and written communication skills
• Demonstrated ability to effectively organize and execute tasks
• Computer proficiency with Microsoft office and understanding of CTMS/EMR software
• High level of critical thinking

Travel Requirements

• No travel required

Education, Credentials, And/or Trainings Required

• Associates or Bachelor's degree in healthcare, clinical research management, or related required
• Training (appropriate to anticipated duties study-specific training, or other as applicable to assigned responsibilities).

Benefits & Perks

• Accrued Sick Time

EEO statement

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.