Overview
Study Start-up Associate SeniorUS RemotePrimary PurposeThe Study Start-up Associate Senior drives the preparation, communication with sites, submission, and maintenance of regulatory packages for clinical trials, ensuring full alignment with global and local requirements. This role may oversee, lead and coordinates global, regional and/or in-country activities. Supports streamlined site activation by developing and organizing submission dossiers, tailoring ICF/AF materials to regional/country regulations, and maintaining high-quality trackers and templates. Acting as a key connector across sites, cross-functional teams, and regulators when apply, the Study Start-up Associate Senior contributes to accelerated Study Start-up timelines through precise documentation and proactive collaboration.
Responsibilities
- Prepare, adapt, and submit high-quality regulatory and ethics packages to Regulatory Authorities and Ethics Committees, ensuring compliance with country regulations and ICH/GCP.
- Coordinate timelines, country-specific strategies, and projections for EC/RA submissions, ensuring deliverables meet sponsor-agreed milestones.
- Adapt and customize Informed Consent and Assent Forms (ICF/AF) per local regulatory requirements and quality standards.
- Track, collect, review, and maintain essential and site-level regulatory documents required for study activation.
- Serve as a primary contact for study teams, sponsors, and sites to facilitate efficient communication and accelerate regulatory approvals.
- Ensures the appropriate strategy to solve issues with the stakeholders, applying lessons learned accordingly with each country.
- Prepare and coordinate ongoing submissions, amendments, safety notifications, and regulatory updates throughout start-up.
- Acts as a Subject Matter Expert delegated by the manager for communication with the RA, leading the regulatory matters in the assigned country.
- Serves as the point of contact for regulatory topics in the assigned country. Lead and participate in calls with Regulatory Authorities when required.
- Maintain accurate study trackers, including site-level document status, country submissions, and overall start-up progress.
- Assist in creation and maintenance of project timelines and start-up planning tools.
- Review regulatory documents and submissions for completeness, accuracy, and alignment with internal and external requirements.
- Support translation needs and country-specific administrative requirements (e.g., data protection, import licenses).
- Coordinate with CRAs and study team members to ensure timely provision of high-quality regulatory documents for site activation.
- Identify process gaps or technical challenges and propose solutions to optimize compliance, timing, and quality.
- Provide updates to Leads/Managers and escalate risks, delays, or out-of-scope activities as needed.
- Contribute to development, maintenance, and improvement of SOPs, templates, tools, and best practices for regulatory submissions.
- Mentor or support junior team members as required, fostering knowledge sharing and consistent submission standards
Qualifications
- Bachelor degree preferably in (life) sciences.
- 6+ years of experience in study start-up and/or regulatory affairs for clinical research, with at least 2 of those 6 years in more than 2 countries.
- Intermediate English proficiency (B1).
- Strong knowledge of clinical research processes, including study start-up and medical terminology.
- Deep understanding of local regulatory regulations, processes, and quality requirements.
- Excellent verbal and written communication skills, able to convey complex ideas to study personnel, sponsors, and internal teams.
- Highly organized, proactive, and able to manage multiple competing priorities across various clinical trials.
- Ability to work independently and collaboratively within a matrix team environment.
- Strong analytical, problem-solving, and planning skills, ensuring timely and high-quality execution of study activities.
- Excellent interpersonal skills and positive attitude.
- Ability to coordinate, prioritize, and execute study start-up activities.
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our
Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Work From Home Anywhere in the US
- Casual Dress Code & Work Environment
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