QA Monitor, Clinical Research

Job Description

A large healthcare provider in Philadelphia, PA is seeking a QA Monitor for their oncology clinical research team. The monitor reviews all clinical trials conducted by the Sidney Kimmel Cancer Center (SKCC) at Jefferson. Extra emphasis is placed on the therapeutic investigator initiated studies being conducted within the SKCC and the SKCC initiated multisite trials. The monitor ensures protocol compliance and data quality internally and at the clinical research sites via remote and on-site monitoring. Essential Functions:

• 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.) and TJU/SKCC policies.
• Maintain knowledge of current GCP standards and FDA regulations.
• Participate in the development or revision of SOPs to support compliance.
• Conduct clinical research training for new hires, existing staff, clinical investigators, and other Jefferson enterprise staff as needed.

Skills and Requirements

• 4+ years of clinical research experience as a Clinical Research Coordinator, Clinical Research Data Manager, Clinical Research Monitor, or related role supporting clinical trials (not solely regulatory experience).
• Strong knowledge of GCP, FDA regulations, and clinical research compliance requirements.
• Experience should entail a blend of patient recruitment, informed consent, study visits, source documentation, and/or data capture using an electronic data capture system.
• Experience reviewing source documentation, study records, and clinical trial data to ensure protocol compliance and data quality.
• Oncology clinical research experience

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].