"Clinical Research Monitoring and Auditing Specialist (Abramson Cancer Center)"

The Abramson Cancer Center (ACC) Department of Operations, Compliance and Monitoring (DOCM) is seeking a Clinical Research Quality Specialist, Sr. to support our clinical research mission. The ACC clinical research portfolio comprises hundreds of studies with many being conducted across the US and in other countries. The Quality Specialist, Sr. is responsible for scheduling, coordinating and conducting monitoring and/or auditing of oncology studies across the Abramson Cancer Center which includes 12 schools, HUP, PPMC, PAH, CCG, ABBCI@LGH, PMPH, CHOP, all ACC network and affiliates as well external sites participating in ACC initiated clinical research.

Job Responsibilities:

• Perform monitoring and auditing visits of all ACC studies as assigned.
• Conduct visit close-out meetings with study teams and investigators.
• Prepare formal reports of audit findings following NCI/CTEP quality and compliance standards.
• Assist with the development and implementation of corrective and preventative action plans and training related to research compliance, quality control and quality assurance to ensure compliance with federal regulations and NIH and NCI mandates.
• Play a vital role in performing quality reviews of pharmacovigilance data that are evaluated and acted on by the ACC Data and Safety Monitoring Committee.
• Strictly adhere to all ACC DOCM policies and procedures as well as have a thorough understanding of federal and local policies and guidance for the conduct of clinical research.
• Ensure data entered into case report form is accurate, complete and verifiable.
• Confirm documentation pertaining to investigational product administration and chain of custody for applicable studies.
• Confirm documentation pertaining to biospecimen collection, storage and chain of custody for applicable studies.
• Complete visit reports and follow up letters per standard operating procedures.
• Create and conduct training of investigators, sponsors and clinical research staff in areas related to clinical research.
• Provide preparation support for inspections by external bodies such as the FDA, EMA, the NCI and CTEP.
• Produce deliverables and take actions following strict deadlines for all tasks to ensure compliance with NCI requirements.
• Mentor junior compliance team staff members and work collaboratively with other DOCM functional teams.
• Perform additional duties as assigned.

Qualification:

Bachelor's degree or BSN and 5-7 years of clinical research experience with a minimum of 5 years of experience as a clinical research nurse or research coordinator and at least 3 of those years directly monitoring/auditing or preparing for and fully supporting monitoring/auditing visits of oncology trials or equivalent combination of education and experience is required. PREFERENCE WILL BE GIVEN TO RN/BSN APPLICANTS. Candidates must have an advanced working knowledge of oncology, NCTN cooperative groups, RECIST, CTCAE and NCI requirements for the conduct of research in cancer centers. Additional experience in clinical research i.e., Data Management, Project Management, Drug Safety are a strong plus.

The appropriate candidate will possess a thorough knowledge of federal regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality Assurance; understand the application of federal, local and institutional regulations as they apply to the conduct of human subjects research. Must have a working knowledge of the operations and organization of clinical care of patients, medical records/patient charts organization and terminology, have experience navigating Electronic Medical Record systems such as Epic. Exceptional technical writing skills are essential to the success of the candidate. The candidate is expected to be detail oriented; have excellent organizational and time management skills in a very diverse setting; be able to exercise discretion in working with highly confidential and sensitive matters; must be able to work independently, multi-task and prioritize; and must be able to work under pressure while exercising mature judgment, resourcefulness and initiative.

This job is not only about your technical skills; it's about how you lend your positivity and presence, combined with your skill set to an energized environment and highly collaborative team. This job description is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. Some work-related responsibilities may occur outside of regular business hours. Work requires travel between offices and entities. Position is contingent upon continued funding.