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Operational Compliance Specialist

Operational Compliance Specialist

  • Anywhere

SUMMARY

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The primary responsibility of the Operational Compliance Specialist is to assist Operational Compliance Management in executing day-to-day tasks associated with managing, maintaining, and continually improving Imaging Endpoints’ Operational Compliance processes.  The Operational Compliance Specialist interfaces with Compliance and Regulatory Affairs and Imaging Operations teams at all levels, with support activities provided in areas including, but not limited to, document change control, proposal, and document review, administering of training, inspection readiness assessments, and nonconformance file (CAPA and Deviation) management.

The Operational Compliance Specialist is a compliance and solutions oriented individual, facilitating timely management quality decision making.  This individual is key in achieving business and stakeholder needs with respect to quality assurance principles and practices.

RESPONSIBILITIES

  • Provide quality system management assistance within the regulations of investigational products and quality standards, specifically: 21 CFR Part 312, 21 CFR Part 211, ICH E6 and ISO standards.
  • Provide direct QA support related to Imaging Endpoints’ training programs and nonconformance management (deviation program and CAPA program).
  • QA responsibilities include, but are not limited to, documentation creation, editing and/or review for procedures related to operations, QMS, etc.
  • Assist in document control responsibilities for study related documents.
  • Assist in proposal review.
  • Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional and organizational relationships to drive compliance to specified program objectives.
  • Interface with Compliance and Regulatory Affairs Management to implement quality system strategies and plans, relevant to the defined role, which then facilitate continuous QMS improvement.
  • Interface with other areas of the organization to provide sound QA decision-making in operational processes.
  • Assist in responding to operational issues to prevent deviation and CAPA occurrence.
  • Assist in the management, maintenance, and reporting of IE’s CAPA and Deviation systems, including discrepancy investigation, reporting, and tracking and trending activities.
  • Assist Compliance and Regulatory Affairs Management during Study Audits, Internal Audits, Sponsor Audits, or Regulatory Inspections, including the effective preparation of related documentation, training of staff, providing accurate information and tracking of audit responses.
  • Assist Operational Compliance Management in managing Inspection Readiness Assessment and/or audit activities.
  • Evaluate the state of compliance regarding study set-up and close out activities including remediation and reconciliation of TMF documentation.
  • Assist the Compliance and Regulatory Affairs Management in establishing and reporting quality metrics.
  • Ensure proper control, retention, and archival of documentation.
  • Assist in implementing and maintaining QA procedures and controls to ensure the IE QMS is compliant to current industry requirements.
  • Perform other duties as assigned by Compliance and Regulatory Affairs Management.
  • Act in a supporting role to other Compliance and Regulatory Affairs Specialist positions.

EDUCATION AND EXPERIENCE

  • Bachelor’s degree in pharmaceutical sciences or other related scientific disciplines.
  • Minimum five (5) years of experience in a regulated industry with at least three (3) years of experience in pharmaceuticals, clinical research, and/or medical device.
  • Prior experience of development and maintenance of a QMS system and operational experience.
  • Prior experience in Imaging Core Lab and/or Contract Research Organization preferred.
  • Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, ISO standards, and Good Clinical Practices (ICH E6 GCP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMPs).
  • Good working knowledge of CAPA/deviation processes, investigational methodologies and procedures.
  • Proficiency in MS Office and internet applications.
  • Prior experience with training, deviation and CAPA document administration.

SKILLS

  • Work precisely and in compliance with all procedures, rules and regulations.
  • Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
  • Excellent interpersonal, organizational and communication skills, including oral and written.
  • Self-motivated and able to grasp new concepts and learn quickly.
  • Ability to motivate others and facilitate a positive work environment.
  • Ability to manage projects and deliverables with a high level of accuracy and completeness.
  • Ability to work independently with minimal supervision.
  • Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel, and Power Point.

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

  • Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
  • Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
  • Commitment and caring for our fellow team members, their families, and the communities IE serves – see more information about Caring Endpoints at https://imagingendpoints.com/caring-endpoints/
  • Integrity and high ethical standards; we always do the right thing
  • High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
  • Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
  • Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
  • High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: Estimated up to 10% travel (domestic and international)

To apply for this job email your details to tmagee@imagingendpoints.com

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