DOCM Senior Auditor - Contract - Philadelphia PA
Proclinical is seeking a Senior Auditor to support our clinical research mission.
Primary Responsibilities:
The ACC clinical research portfolio comprises hundreds of studies with many being conducted across the US and in other countries. The Sr. Auditor is responsible for scheduling, coordinating and conducting monitoring and/or auditing of oncology studies across the Cancer Center.
NOTE: Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite multiple days a week in Philadelphia and working locally off-site. Applicants must live within a reasonable commute to downtown Philadelphia. Fully remote work options are not available.
Skills & Requirements:
- Bachelor's degree or BSN
- 5-7 years of clinical research experience
- 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.
- 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.
- PREFERENCE WILL BE GIVEN TO RN/BSN APPLICANTS.
- Ability to work independently, multi-task, and prioritize in a diverse setting.
- Discretion in handling confidential matters.
- Willingness to travel between offices and entities.
- Must live within a reasonable commute to downtown Philadelphia.
The DOCM Sr Auditor's responsibilities will be:
- 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 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.
- Produced 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.
If you are having difficulty in applying or if you have any questions, please contact Natalie Magola at n.magola@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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