Start-Up Specialist - FSP

Fortrea•Durham, CA

8d•$50,000 - $70,000•Remote

About The Position

The Start-Up Specialist is the primary contact for investigative sites during study start-up and maintenance. The role is responsible for collecting required investigator and essential documents and ensuring EC/IRB, third body, Regulatory Authority, and other local applications are submitted within agreed timelines and meet applicable regulatory and sponsor requirements. The specialist proactively communicates with these bodies about requirements, stays informed of current regulatory standards, and serves as a local expert in start-up activities for an assigned country or region. The role may also mentor and train new hires and less-experienced colleagues. The specialist coordinates and prepares regulatory submissions, reviews final submission documents, liaises with sites and vendors, and tracks start-up and maintenance work to ensure compliance with client expectations, budgets, applicable laws and guidelines, ICH/GCP, SOPs, and quality standards. The role also supports site activation strategy and informed-consent customization, may assist with site contract and budget negotiations, and identifies and escalates risks or out-of-scope work. Work is performed in an office environment, with frequent travel to client or site locations and occasional domestic and international travel. Varied hours may be required. The target pay range is $50,000–$70,000.

Requirements

At least 2 years of work experience in clinical research, including strong working knowledge of ICH guidelines and Regulatory Authority and IRB/IEC regulations.
At least 2 years of experience in clinical development or start-up/regulatory processes.
Working knowledge of ICH, Regulatory Authority, IRB/IEC, and other applicable regulations and guidelines.
Familiarity with investigator start-up documents and the contract and budget negotiation process.
Experience interacting with operational project teams and investigative sites.
Demonstrated understanding of research protocol requirements and ability to communicate and educate others about them.
Ability to work in a fast-paced environment where protocol deviations are not allowed and missed timelines can create quality issues.
Ability to adapt and reprioritize when priorities change.
Teamwork and people skills.
Comfort working in a technology-based environment where data is collected electronically.
Ability to sit for extended periods and operate a vehicle safely.
Repetitive hand movements and ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Ability to crouch and stoop occasionally, and bend and twist the upper body and neck frequently.
Ability to access and use a variety of in-house and off-the-shelf computer software.
Ability to lift and carry light to moderate objects, including luggage and a laptop, with a maximum lift of 15–20 pounds.
Regular and consistent attendance.
A university or college degree, preferably in life sciences, or certification in a related allied health profession from an appropriate accredited institution, such as nursing certification or medical or laboratory technology. Relevant and equivalent experience may be considered in lieu of education. Alternatively, a high school diploma or equivalent plus at least 2 years of clinical research experience and strong working knowledge of ICH guidelines and Regulatory Authority and IRB/IEC regulations will be considered.
Reside in the United States.

Nice To Haves

Life science degree preferred.
Certification in a related allied health profession, such as nursing certification or medical or laboratory technology.
Experience mentoring or training new hires and less-experienced colleagues.

Responsibilities

Maintain awareness of regulatory legislation, guidance, and practices in assigned countries.
Coordinate, collect, and organize information required by EC/IRB, third bodies, and Regulatory Authorities, including preparing study documentation such as country application forms and cover letters for sponsor review when applicable.
Compile and prepare routine submissions to IRB/IEC, third bodies, and Regulatory Authorities, such as INDs and CTAs, and liaise with them regarding submissions and approvals.
Liaise with internal and external vendors on Regulatory Authority submissions as applicable.
Review final submission documents as applicable.
Keep assigned start-up and maintenance activities on track, within client expectations and budget, and compliant with applicable laws, guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
Identify and escalate study issues appropriately and promptly.
Perform other duties assigned by management, depending on country and situational requirements, with proper supervision where applicable.
Serve as the primary contact for investigative sites and ensure required documents are collected promptly.
Collect and track required documents; perform quality review, formatting, and compilation of final documents for compliant site activation and maintenance without supervision.
Ensure high-quality documents are filed and systems are updated promptly and continuously to support audit readiness.
Participate in team and project meetings as applicable.
Assist with defining site activation strategy when needed and provide accurate projections and timelines to study teams.
Review and customize country- and site-specific patient informed consent forms for compliance with local requirements and protocol; resolve informed-consent issues and other potential difficulties with sites.
Support negotiation of site contracts and budgets when applicable, track contract and budget milestones, and intervene or escalate as appropriate.
Identify and escalate risks to deliverables to Submission Leads.
Notify the Submissions Lead of hours identified as out-of-scope or overburn.
Perform other duties as needed or assigned.
Mentor and train new hires and less-experienced department colleagues if suitable.