Job Summary:

The Research Quality Assurance Coordinator ensures compliance with ICH-GCP guidelines, study protocols, and internal quality standards while supporting ongoing inspection readiness across all NEXT Oncology sites.

Essential Duties and Responsibilities:

Essential and other important responsibilities and duties may include but are not limited to the following:

Review and comprehend the research study protocol

Verify that all protocol requirements have been captured on source documents for each study protocol

Assess protocol for discrepancies or questions to ensure accurate creation of source documents

Perform internal audits to evaluate compliance with regulatory guidelines, research study protocols and internal quality standards

Support site preparedness to maintain inspection readiness at all sites

Collaborate with departmental teams to identify, address and resolve quality deficiencies

Other duties as assigned

Knowledge, Skills and Abilities:

Knowledgeable of standard research practices.

Effective communicator.

Knowledge of appropriate software including Microsoft Word, Excel, and Outlook, Microsoft PowerPoint, and Adobe Acrobat

Attention to detail, organized and accurate in work product.

Bilingual in English/Spanish, preferred.

Required Education and Experience:

Bachelors degree in the Sciences. Certification is not required.

Oncology clinical trial experience preferred.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires full range of body motion including handling and lifting, manual and finger dexterity, and eye-hand coordination.

Requires sitting and standing for extensive periods of time.

Occasionally lifts and carries items weighing up to 40 lbs.

Must have vision and hearing that are effectively functional with or without corrective measures.