As part of our continued commitment to providing a safe and healthy workplace, Phoenix Children’s is officially a mandatory COVID-19 vaccination organization, effective October 1, 2021. All new employees must be fully vaccinated prior to starting employment at Phoenix Children’s. Having a vaccinated workforce is an important step in supporting our mission to provide hope, healing and the best healthcare for the children in our community.

Position Details

Department: RSRCH-GRNT | Clinical Research Admin
Category: Research
Location: Phoenix
Posting #: 713598
Date Posted: 12/9/2022
Employee Type: Regular

Position Summary

This position is responsible for conducting comprehensive research audits and monitoring of clinical trials to ensure faculty, staff, employees and students engaged in research activities are compliant with all aspects of federal, state and local policies and regulations governing clinical research. This position reviews internal regulatory documentation, protocols, amendments, correspondence, case report forms, study data, research billing reports, and adverse event reports. This position also determines overall protocol compliance which includes review of the consent process and eligibility criteria. Medical records, laboratory data, and other source documentation is utilized to examine study data accuracy and completeness. This position prepares audit and monitoring reports based on findings, works with research management to create corrective and preventative action plans, and assists in the development of education and training with respect to the conduct of clinical trials. The Clinical Trials Compliance Analyst is an integral member of the Office of Research. Under the direction of the Director, Research Operations, the Clinical Trials Compliance Analyst promotes and facilitates a culture of compliance through audit activities designed to identify risk and support adherence with Federal, State, and Local Regulations and Guidelines. This includes but is not limited to providing educational programming and tools to facilitate compliant research, conduct quality assurance reviews of data to support reporting and working with the research community to establish standards. The Clinical Trials Compliance Analyst works closely with the Manager of Clinical Research to develop quality/compliance training programs and assists with the delivery of training programs.

PCH Values

  • Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
  • Excellence in clinical care, service and communication
  • Collaborative within our institution and with others who share our mission and goals
  • Leadership that set the standard for pediatric health care today and innovations of the future
  • Accountability to our patients, community and each other for providing the best in the most cost-effective way.

Position Duties

  1. Under the direction of the Director, Research Operations, schedules, prepares and conducts audits and assessments of clinical research studies.
    • a. Audits and monitors clinical research studies from inception through closure. Interprets regulations and guidance documents governing FDA, OHRP, ICH/GCP and applies the interpretation to daily work.
    • b. Provides timely feedback by means of the audit report and ensures timely completion of all audit related activities.
    • c. Ensures that all human subject or clinical trial audit reports are accurate and of the highest professional quality.
  2. Develops, executes and maintains audit schedules according to the needs of the department.
    • a. Participates in selection of protocols based on risk matrix.
    • b. Evaluates the potential risk of compliance deficiencies related to audit outcomes.
  3. Assists in the development of corrective and preventative action plans and in the review of completed action plans.
    • a. Works with research management to develop plans based on audit/monitoring findings.
    • b. Tracks, collects and reports responses to action plans. Monitors for completion.
  4. Works closely with the Manager of Clinical Research to develop quality/compliance training programs and assists with the delivery of training programs.
  5. Performs miscellaneous job related duties as requested.

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Position Qualifications

Please review the following qualifications and specify whether you meet each of the requirements listed.
Do you meet this requirement?
1. Bachelor's Degree in a related field Required
2. Masters Degree in a related field Preferred
Do you meet this requirement?
1. Five (5) or more years of clinical research experience Required
2. Two (2) or more years of clinical trials auditing/monitoring experience Required
Do you meet this requirement?
1. Industry-recognized certification (i.e., CCRC, CCRA, CCRP) Required
2. GCP and human subjects protection training Required
Do you meet this requirement?
Special Skills
1. Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines Required
2. Knowledge of IRB and federal regulations as they pertain to human subject research and the ability to interpret and apply laws and regulations to ensure the overall protection of human participants Required
3. Project management skills, including the ability to identify needs, develop action plans, and manage projects to completion. Ability to multitask and to work efficiently and independently Required
4. Proven ability to communicate effectively within an interdisciplinary team to ensure safe, efficient, quality patient care Required
Physical Requirements & Occupational Exposure/Risk Potential
1. Physical Requirement - Feeling (sensing textures and temperatures) Occasionally
2. Physical Requirement - Fine Motor Skills (pinching, gripping, etc) Frequently
3. Physical Requirement - Hearing Constantly
4. Physical Requirement - Pushing/pulling Occasionally
5. Physical Requirement - Reaching Occasionally
6. Physical Requirement - Sitting Frequently
7. Physical Requirement - Standing Occasionally
8. Physical Requirement - Stooping/crouching/kneeling/crawling Occasionally
9. Physical Requirement - Talking Frequently
10. Physical Requirement - Walking Frequently
11. Physical Requirement - Near Vision Frequently
12. Physical Requirement - Far Vision Frequently
13. Physical Requirement - Color Discrimination Frequently
14. Physical Requirement - Use of keyboard, mouse and/or computer equipment Frequently
15. Physical Requirement - Lift up to 35 pounds without assistance Occasionally
16. Occupational Exposure/Risk Potential - Inside office environment Applicable
17. Occupational Exposure/Risk Potential - Confined areas Applicable
18. Occupational Exposure/Risk Potential - Airborne communicable diseases Applicable
19. Occupational Exposure/Risk Potential - Bloodborne pathogens or bodily fluid Applicable
20. Occupational Exposure/Risk Potential - Fumes or airborne particles Applicable
21. Occupational Exposure/Risk Potential - Hazardous materials exposure Applicable
22. Occupational Exposure/Risk Potential - Radiation exposure Applicable
23. Occupational Exposure/Risk Potential - Toxic or caustic chemicals Applicable
I have reviewed the qualifications, physical requirements and occupational exposure/risk potential for this position and wish to apply