Manager, Clinical Research Quality

St. Luke’s University Health Network•Allentown, PA

About The Position

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Manager of Clinical Research Quality is responsible for the oversight, development, and implementation of the clinical research quality management system across a community hospital system conducting both oncology and non-oncology clinical trials

Requirements

Bachelor’s degree in a health science, life science, nursing, or related field required.
Minimum of 5 years of experience in clinical research in a monitoring role or at a research site, with at least 2 years in a quality management, regulatory, or compliance role.
Subject Matter Expert in ICH-GCP, FDA regulations (including, 21 CFR Parts 11, 50, 54, 56, 312, and 812), and HHS regulations (45 CFR 46).
In-depth knowledge of Microsoft Office Programs: Word, Excel, PowerPoint, Outlook; Internet Functions required.
Experience with both oncology and non-oncology clinical trials.
Previous experience in a hospital-based or health system clinical research environment.
Strong organizational and communication skills.
Excellent analytical and problem-solving skills.
Proficiency in electronic regulatory systems, clinical trial management systems, and other research focused systems.

Nice To Haves

Master’s degree preferred.
Clinical Research Certification (e.g., CCRC, CCRP, CCRA) preferred.

Responsibilities

Oversees the clinical research Quality Management System and its compliance with federal, state, and local, regulations, Good Clinical Practice (GCP), as well as institutional policies and procedures, including IRB and Network Compliance.
Chair the department Quality Management Committee, setting agendas, reviewing quality metrics, and guiding process improvement and training efforts.
Develop, maintain, and implement department Standard Operating Procedures (SOPs) that are compliant with all applicable regulations, policies, and Good Clinical Practices (GCP).
Lead recurring SOP review cycles with document authors, process owners, and subject matter experts, and coordinate ad-hoc updates in response to changes in regulations, GCP, and/or internal policies and processes.
Serve as the point person for monitoring for and interpreting new regulations affecting the clinical research process and quality management system and disseminating impact to staff and investigators.
Oversees and facilitates the Clinical Trials Office training and education program, delivering role-specific instruction per training matrix on SOPs and research processes, including knowledge assessment and competency checks, to ensure consistent knowledge and compliant research conduct across all study teams, investigators, and supporting departments.
Oversee and enhance research readiness process for new investigators and clinical research staff including overall training profiles, initial onboarding, and ongoing compliance with institutional general and role-specific procedural qualifications and training.
Responsible for tracking and managing training records for researchers, ensuring documentation of completed training, work with department leaders in identifying retraining needs, and overseeing the delivery and documentation of all retraining activities.
Collaborate with organization training departments to enhance technology and training records and compliance documentation.
Oversee and manage a risk-based internal quality review program for sponsored and investigator-initiated clinical trials and research, including but not limited to conducting quality reviews of study documentation, regulatory binders, informed consent processes, source documentation, and case report form data.