Site Readiness and Regulatory Senior Specialist

at  Fortrea

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
At Fortrea, we believe in empowering individuals who are passionate about making a difference in the field of clinical research. We offer a dynamic and collaborative environment where your expertise can flourish. Join our team as a Senior Site Readiness and Regulatory Specialist and play a pivotal role in driving the success of our clinical trials. If you’re ready to take your career to the next level and contribute to groundbreaking medical advancements, we invite you to apply and become part of our innovative journey.

Job Summary:

• 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 sites.
• Is the escalation point for negotiations with SUPM/SUCM’s on behalf of less senior colleagues.

Essential Job Duties:

General Tasks

• 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
• Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable]

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

Experience:

Minimum Required:

• More than 4 years of experience in clinical development or regulatory process.
• In depth experience of applying strong knowledge of ICH, RA, IRB/IEC and other applicable regulations/guidelines. Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.
• In depth experience of issue escalation and resolution.
• Credible role model in effective communication and problem solving.
• Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.

Education/Qualifications:

• 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 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
• Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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General Tasks

• 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
• Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable

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 bur