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Sr. Quality Management Support-CAPA Clinical Trials

J. Morrissey

Posted on: 12 Mar 2024

Job Location: New Haven, US

Job Description:

Sr. Quality Management Support-CAPA Clinical Trials

Provides ongoing support to quality management during external audits
Works with the Quality Assurance & Monitoring teams on regulatory authorities such as the FDA and EMA inspection preparedness for human subject clinical trials
Reviews and audits data captured in ONCORE, RAVE, EPIC, REDCAP and other Clinical research software associated with the clinical trial
Draft and implements policies, SOPs, and other educational material to support quality improvement initiatives
Collaborates with data team to ensure systems and software tools are user friendly to the study and associated research team. Makes recommendations on improvements within the data usage
High level of communication with management teams, leadership, peers and end users of all levels during corrective action and education sessions. Ensure's the end user translates corrective action as learning vs discipline. Ensure the education briefings are communicated effectively and clear.
Conducts and creates various reports that will include deficiencies, trends identified in quality review audit.
Participates in workforce orientation, clinical research monitoring and quality reviews, integrity, compliance and privacy initiatives, incident response and documentation, and providing support for policy and procedure development

Requirements:
Must reside in CT or nearby for a Hybrid work model (2 days on site per week) 3 days remote
Experience:

Senior Level Clinical Research experience with Human Subject studies
Senior Level Audit and CAPA experience including corrective and preventive action planning and roll out
7 years' experience with clinical research review, approval & monitoring processes from start-up to close-out
Bachelor's degree in science field. Masters preferred
Clinical Trial Certification such as SOCRA or GCP or obtain within one year after hire
Advanced in software and related technology: ONCORE, RAVE, EPIC, REDCAP or similar. Also, MS suite; Word, Excel
Related Therapeutic studies: Cancer, Oncology, Neuro, respiratory, diabetes or similar encouraged to apply

Full time Direct Hire Salaried Position with highly competitive Benefits including PTO, tuition reimbursement. (May be eligible for sign on bonus if relocation is required)
$95-125K depending on experience level

Attn: Krisha Morander|[email protected]

INDI

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