Job Overview:
Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. The job holder, an SME for local/regional regulations, may work with multiple vendors, drives and coordinates activities across a range of stakeholders in support of site start up delivery. This role liaises with the applicable team to ensure compliance, coordinates best practice solutions within region and coaches others in the more complex areas of SU. The Senior Site Readiness and Regulatory Specialist proactively anticipates and mitigates issues that could delay start up across a range of site. Is the escalation point for negotiations with SUPM/SUCM’s on behalf of less senior colleagues.
Summary of Responsibilities:
- Responsible for maintaining awareness of regulatory legislation, guidance and practice, ICH/GCP and relevant Sponsor requirements.
- Take ownership in the preparation (collection, organization and compilation) of routine submissions filed to IRB/EC/Third body/Regulatory Authorities (e.g., INDs/CTAs) including but not limited to the preparation of study documentation such as review/summarize scientific/research documents, country application form and cover letter for sponsor review as applicable.
- Complete submissions to and liaise with IRB/IEC/Third body/Regulatory Authority as applicable regarding submission/approval issues.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
- Perform a review of final submission documents as applicable.
- Ensure appropriate systems are updated accurately and compliantly, ensuring others follow established processes.
- Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
- Mentor and coach other Site Readiness and Regulatory Operations team members.
- In-Country specific tasks (Global):
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
- Collect and track all the necessary documents required and perform a quality review, formatting and compilation of the final documents for effective and compliant site activation and maintenance without supervision and liaise with stakeholders as applicable in site activation related items.
- When delegated by line manager, oversee and ensure quality data and audit readiness.
- Participate independently and take lead (as applicable) in client meetings to proactively liaise on issues related to site activation and maintenance.
- Develop project specific plans for the Site Activation component of assigned studies.
- Review and approve projections and timelines to study teams, ensuring that they accurately represent the country’s performance and suggests mitigation actions in agreement with line manager.
- Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by line manager.
- Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites.
- Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual.
- May take country lead role for specific projects/tasks with the applicable mentoring and supervision.
- Proactively identifying, preventing and escalating to Submission Leads any risk to meeting deliverables and participate in strategy meetings to mitigate them.
- Notify the Submissions Lead of hours identified as Out-of-Scope or over burn.
- Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):
- Responsible for the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.
- And all other duties as needed or assigned.
Qualifications (Minimum Required):
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 1 year work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
Physical Demands/Work Environment:
- General Office Environment.
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