Start Up Specialist, FSP

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Start Up Specialist, FSP in the United States.

This role plays a critical part in the clinical trial site activation process, ensuring that investigative sites are fully prepared and compliant to initiate studies efficiently and within regulatory timelines. You will act as the primary point of contact for sites during start-up and maintenance activities, coordinating the collection, review, and submission of essential regulatory and investigator documentation. Working in a fast-paced clinical research environment, you will collaborate with internal study teams, vendors, and regulatory authorities to ensure accuracy, compliance, and timely approvals. This position requires strong knowledge of ICH-GCP guidelines and regulatory frameworks, as well as the ability to manage multiple priorities across studies. You will also contribute to process improvements, risk identification, and cross-functional alignment to support successful study execution. In addition, you may serve as a mentor and subject matter resource for less experienced colleagues, strengthening overall team capability.

Accountabilities:

In this role, you will manage end-to-end site start-up activities while ensuring compliance with regulatory requirements and study timelines. You will be responsible for maintaining accurate documentation and supporting effective communication between all stakeholders involved in clinical trial activation.

Serve as the primary contact for investigative sites during start-up and maintenance activities, ensuring timely collection of essential regulatory and investigator documents
Coordinate, prepare, and review submissions to IRBs/IECs and regulatory authorities, including study applications, informed consent forms, and related documentation
Ensure all submissions and site activation activities comply with applicable regulations, ICH-GCP guidelines, sponsor requirements, and internal SOPs
Track, manage, and maintain high-quality documentation systems to ensure audit readiness at all times
Collaborate with internal teams, vendors, and external regulatory bodies to support submission processes and resolve issues proactively
Identify risks, escalate issues appropriately, and support resolution to ensure study timelines and deliverables are met
Support contract and budget tracking activities and assist in site activation strategy and planning when needed

Requirements

The ideal candidate brings strong clinical research experience with a solid understanding of regulatory start-up processes and site activation workflows. You are detail-oriented, organized, and confident working in a highly regulated, deadline-driven environment.

Bachelor’s degree in life sciences or related field, or equivalent clinical/healthcare certification, or relevant experience in lieu of degree
Minimum of 2 years of experience in clinical research, including exposure to site start-up and regulatory processes
Strong knowledge of ICH-GCP guidelines, IRB/IEC processes, and regulatory authority requirements
Experience working with clinical trial documentation, informed consent forms, and site activation deliverables
Familiarity with Canadian and/or US site processes is strongly preferred
Excellent organizational, communication, and multitasking skills with the ability to manage multiple studies simultaneously
Strong problem-solving skills and ability to proactively identify and escalate risks
Ability to work collaboratively with cross-functional teams, sites, and external stakeholders
Previous experience in clinical operations or regulatory submissions is highly valued

Benefits

Competitive annual salary range of $67,000 to $70,000 USD
Remote work flexibility within the United States
Opportunity to contribute to life-saving clinical research and global healthcare innovation
Exposure to international clinical trial processes and regulatory environments
Collaborative, mission-driven work culture focused on quality and patient impact
Career development opportunities within clinical operations and regulatory functions
Engagement with cross-functional global teams across clinical research programs.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Requirements

Benefits

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