Quality Assurance Manager – Clinical Research
Primary Function: The Quality Assurance Manager primary responsibility is to supervise all of the Sidney Kimmel Cancer Center (SKCC) QA monitors. This oversight ensures the quality of the monitoring and data integrity of the research being performed by the SKCC.
Manage and maintain the portfolio of SKCC Standard Operating Procedures (SOPs).
Participate in the development or revision of SOPs to support compliance.
Coordinates the ETCTN audits for the SKCC and the NCTN affiliate audits.
Performs reviews/monitoring of all clinical trials conducted by the SKCC. This includes monitoring of external sites participating in SKCC research.
The monitor is responsible for proactive noncompliance issue identification, escalation, and creation of Corrective and Preventative Actions.
Participate in audit preparation, hosting, and post-audit activities to promote the successful outcome of the audit.
Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH GCP, etc.), protocols and TJU/SKCC policies.
Conduct clinical research training for new hires, existing staff, clinical investigators, and other Jefferson enterprise staff as needed.
Identifies clinical research trends based on the Quality Assurance and Process Improvement Unit (QIU) metrics.
Provides reports as needed from the QIU.
Other Core Functions and Competencies:
Maintain knowledge of current GCP standards and FDA regulations.
Interacts with co-workers and other staff consistent with the core values of Jefferson.
Assists the Quality Assurance and Process Improvement Unit Director with administrative responsibilities.
Performs other duties as assigned.
Bachelor’s Degree required
Master’s Degree preferred
Minimum of 2 years’ experience in Quality Assurance
Minimum of 5 years’ Clinical Research experience
Experience with oncology clinical trials and investigator initiated trials is preferred
Familiarity with medical terminology
Skilled managing multiple projects with competing deadlines
Skilled in written and verbal communication
Interested candidates can apply here
, or send CVs directly to Rebecca Kiner for consideration: Rebecca.Kiner@jefferson.edu