Project Closed

Clinical Quality Expert

Flexible clinical (GCP) quality consulting services for a period of approximately four to six months. Support activities include defined tasks such as those related to SOP development and implementation, and incidental/undefined tasks such as consultation on specific issues or events. Regardless of the specific services, all support and advice will be provided in accordance with Good Clinical Practices (GCP) regulations, guidance and industry best practice standards.

Scope listed in order of priority, will be provided by QRCP Solutions, Inc. The specifics for each service may be determined in conjunction with our management team on a situation-by-situation basis and as agreed upon in writing (via email):

    1. Development, review, approval and implementation of key quality and/or operational Standard Operating Procedures (SOPs).
      1. Development of an SOP Project Plan in conjunction with our management team. This will be a risk and priority based plan with target timelines, resource requirements and will be used to track progress/communicate document status.
      2. The initial focus will be on completion of current SOPs in draft form and will include implementation (training) in conjunction with sponsor GMP Quality Assurance (QA) personnel and/or consultants.
      3. An assessment of risk-based priorities for additional SOPs will be conducted. Creation and implementation of new SOPs will be executed on a priority basis in accordance with the agreed upon SOP Project Plan.
      4. As requested/appropriate, execution of Clinical QA responsibilities as assigned per SOPs.
    2. Strategic support for the Clinical Operations team, including scheduled meetings and incidental support as needed.
      1. Participation in regularly scheduled Clinical Operations meetings as requested for specific agenda topics and/or on a weekly or biweekly basis, as preferred by management.
      2. Timely assessment of issues and events as needed, such as:
        • Answering quality, regulatory compliance, and process development questions as they arise. This would include answering questions by telephone or email and would include telephone or email support during an audit or inspection, if needed.
        • Reviewing quality, regulatory and procedural documents (such as SOPs, audit reports, CAPAs, supplier qualification responses or other quality related documentation) as requested; such documents will be reviewed electronically (i.e., must be provided in a format that allows electronic comments).
        • Researching regulations and providing informal feedback to assist with compliance questions.
        • Written compliance summaries and/or reports to be included in a trial master file or other documentation dossiers required or intended for regulatory filing or regulatory inspection purposes
        • Assisting with the investigation of regulatory compliance concerns, quality issues, client complaints, audit and/or inspection findings by phone or email. – Preparing materials for, and/or providing training on GCP related topics.
    3. Vendor and/or study site assessments and/or audits as needed.
      1. If needed, remote (desktop) assessments and/or audits may be performed using questionnaires, Physical (onsite) audits may also be conducted on a risk basis