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Sr. Quality Management Support-CAPA Clinical Trials

New Haven, CT

Posted: 02/06/2024 Employment Type: Direct Hire Industry: Healthcare Job Number: 11297 Salary / Pay Rate : $95-125K

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

Must reside in CT or nearby for a Hybrid work model (2 days on site per week) 3 days remote
  • 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|KrishaM@jmorrissey.com


Meet Your Recruiter

Krisha Morander, CPC
Vice President, Healthcare & Information Technology

Krisha's journey in the professional world has been nothing short of remarkable. Starting her career after completing her college education, she ventured into the realms of Commercial Art and Marketing, honing her creative and strategic skills. However, her path took a significant turn as she discovered her calling in the field of Recruitment.

Growing up in a close-knit, caring family where everyone played a vital role in supporting each other, including the care of elderly parents, Krisha's deep-rooted passion for healthcare began to flourish. She redirected her focus towards assisting job seekers in finding meaningful careers in healthcare that could make a genuine difference in the lives of others.

With an impressive 31-year career in the Staffing Industry, Krisha's expertise spans various domains. Initially, she dedicated herself to agency firm work, with a primary focus on healthcare and marketing communications. Her journey took a pivotal turn in 2004 when she joined J Morrissey. Here, she embraced Direct Hire Healthcare recruitment as her specialization.

In 2010, Krisha's entrepreneurial spirit led her to create the Information Technology division within the organization. Her dedication and exceptional performance in this role earned her the prestigious title of Vice President. She continues to pursue her passion for recruiting top-tier talent and nurturing new client relationships. Krisha also takes an active role in training and mentoring new staff, instilling in them the best practices and the art of meaningful interviewing.

Krisha's Direct Hire Recruitment Specialties encompass both Healthcare, spanning clinical and non-clinical roles, and Information Technology, from junior-level positions to the highest echelons of C-Suite leadership.

Outside of her illustrious career, Krisha finds solace and inspiration in the world of watercolor painting. Her creative spirit knows no bounds.

In her personal life, Krisha shares a blissful marriage of 36 years, a testament to her commitment and enduring love. Together with her loving partner, she is proud to be the parent of two wonderful children, completing her fulfilling life journey.

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