Onsite Clinical QA Lead – FDA/GCP Trials

Bering-Alaka'ina Holdings, LLC; Silver Spring (MD); Sur place; USD 129 000 - 133 000; Plein temps

Avantages offerts par ce poste

401K with match

Medical insurance

Dental insurance

Disability insurance

Life insurance

Paid time off

11 holidays

Tuition reimbursement

Résumé du poste

Bering-Alaka`ina Holdings, LLC is seeking a Quality Assurance Officer to support onsite clinical trial activities in Silver Spring, Maryland. You will ensure QA/regulatory compliance, conduct audits, and review data and documentation to support sponsors.

The role requires 5+ years in QA for clinical trials, knowledge of ICH/GCP, and development/maintenance of SOPs. Onsite work with potential leadership of staff and cross-team coordination within the Clinical Trials Center.

Qualifications

• Must have an Associate's degree and four plus (4+) years of experience.
• Bachelor's degree is preferred.
• Minimum of five (5) years of experience in quality assurance for clinical trials, with expertise in ICH/GCP compliance.
• Certification in quality management (e.g., ASQ) is preferred.

Responsabilités

• Responsible for Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activities.
• Conduct audits and reviews/analyzes data and documentation, including laboratory audits.
• Develop and ensure SOPs compliance; stay updated on Human Subjects’ Protection, FDA, and current GCP regulations.
• Facilitate quality assurance monitoring by study sponsors.
• Coordinate with CTC team to ensure study-wide compliance across phases.
• Prepare monthly status reports and potentially lead a team.

Connaissances

Quality assurance

Regulatory compliance

Audits

Clinical trials

ICH/GCP

SOPs

Team leadership

Formation

Associate's degree

Bachelor's degree preferred

ASQ certification preferred

Description du poste

Bering-Alaka`ina Holdings, LLC is seeking a Quality Assurance Officer to support onsite clinical trial activities in Silver Spring, Maryland. You will ensure QA/regulatory compliance, conduct audits, and review data and documentation to support sponsors.

The role requires 5+ years in QA for clinical trials, knowledge of ICH/GCP, and development/maintenance of SOPs. Onsite work with potential leadership of staff and cross-team coordination within the Clinical Trials Center.