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Research Quality Control Associate

2 months ago

Indianapolis, United States Indiana Hemophilia & Thrombosis Center, Inc. Full time
Job DescriptionJob Description

About IHTC

At the Indiana Hemophilia & Thrombosis Center (IHTC), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.

What You Will Do

As Research Quality Control Associate, you will be responsible for clinical monitoring activities involving Quality Control (QC) and compliance including applicable regulatory requirements and reviewing existing research projects under the direction of Research leadership.

The Opportunity

  • Conduct internal quality control activities, as an internal monitor, to ensure protocol compliance, data accuracy, and patient safety, in compliance with Sponsor protocols, Good Clinical Practices (GCPs), standard operating procedures (SOPs), and applicable agency regulations
  • Report findings to QC and Research leadership and coordinate approved action items for process improvement
  • Collaborate with cross-functional teams to ensure timely completion of study milestones and deliverables
  • Contribute to the preparation of Quality reports and presentations for internal stakeholders
  • Assist the research staff in preparation of sponsors’ audits and Food and Drug Administration inspections
  • May assist with Corrective and Preventive Action (CAPA) plan resolutions as needed
  • Stay current with developments in clinical research regulations, guidelines, and industry best practices
  • Perform other related duties as assigned

This position is designed to be a hybrid role, splitting time between our Indianapolis location and remote work with flexibility provided as needed to accommodate business requirements.

This position may require travel to applicable conferences or on-site meetings, as needed.

Requirements

Requirements

  • Bachelor’s degree in life sciences or related field required
  • Minimum 3 years of progressive experience in research management, monitoring, and/or quality required
  • Certification in clinical research (e.g. ACRP or SOCRA) is preferred
  • Valid driver’s license and insured automobile required
  • Additional knowledge and skills:
    • Knowledge of research methods and procedures sufficient to compile data and prepare reports
    • Knowledge of confidentiality requirements related to patient information
    • Knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements
    • Ability to learn and proficiently utilize diverse eCRF systems, electronic regulatory management systems, Electronic Medical Record systems (EMR).
    • Readiness to adapt new technology
    • Willingness to travel on-site as needed

Benefits

Why join our team?

The IHTC is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package.

The IHTC is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics.

The IHTC is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.

The IHTC participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHTC research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more.

Innovative Hematology, Inc. and the Indiana Hemophilia and Thrombosis Center is an Equal Opportunity Employer.