Study Start-Up Associate II

The Emmes Company, LLC; Rockville (MD); On-site; USD 60,000 - 85,000; Full time

Job summary

The Emmes Company, LLC is seeking a Study Start-Up Associate II to join the centralized Site and Patient Access group in Rockville, MD. You will support regulatory submissions, track essential documents, and coordinate with cross-functional teams to ensure timely startup of international trials.

Responsibilities include creating timelines, preparing submission packages, and maintaining trackers while liaising with sponsors and regulatory authorities as required.

Qualifications

• Bachelor's degree in healthcare-related field required.
• Master's degree healthcare-related field preferred.
• 1–3 years pharma/CRO study start-up experience recommended.

Responsibilities

• Create MS Project files to establish study start-up timelines per country.
• Prepare regulatory submission packages and liaise with regulatory authorities.
• Track missing documents and maintain trackers and templates.
• Coordinate translations and assist in regulatory coordination as needed.
• Support senior staff and study leads in site activation activities.

Skills

Communication

Organizational skills

Prioritization

Independence

Microsoft Office

Education

Bachelor's degree in healthcare-related field

Master's degree healthcare-related field

Tools

MS Project

Word

Excel

Job description

Overview

Study Start-Up Associate II

Be Part of One Team, One Purpose.

At Emmes Group, we're shaping the future of clinical research-where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we've led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Through our two business units-Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions -we are modernizing clinical trials and accelerating the development of life-changing therapies.

We believe that every clinical breakthrough starts with people-people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact.

Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.

As part of Emmes' centralized Site and Patient Access group, the Study Startup Associate II provides administrative support to other team members on preparation of regulatory submission packages on international clinical trials. Gets involved in creation, filing, and updating of trackers and templates and assists in expedited startups and coordinates with other study team members on project specific communication. Liaise with cross functional teams as required.

Responsibilities

• Creates MS project files to establish study start up timelines and processes for each country.
• Works with team members on preparation of regulatory submission packages.
• Tracks and follow up on missing documents.
• Prepares and submits applications to Regulatory Authorities, Central and Local IEC/IRB and other country specific application such as for Data Protection, Import License etc. as required.
• Helps prepare and coordinate activities related to ongoing submissions, amendments, and regular safety reporting and notification to IEC and regulatory authorities as required.
• Tracks the regulatory documents and assist in regulatory coordination, as instructed by other team members.
• Assists in review of the regulatory documents for completeness.
• Assists with translations coordination, e.g., for contracts across EU etc.
• Assists Senior Study Startup Associate and Study Startup Leads in coordinating with the sponsor to secure authorization of regulatory documents.
• Maintains up to date and accurate tracking on the status for each site in study trackers.
• Coordinates with study team members to collect and track essential documents for site activation.
• Interacts with other team members of Study Startup function on project specific status, communication, and deliverables.
• Works to the study timelines, documents/escalates study challenges, and communicates updates to the Lead as required.
• Maintains quality and regulatory compliance among investigational sites during Site Startup Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.
• Performs other duties as assigned
• Complies with all policies and standards

Qualifications

• Bachelor's Degree Healthcare related field Required or
• Master's Degree Healthcare related field Preferred
• 1-3 years working within pharma and/or CRO, preferably 1-2 years of experience in working on study start up activities. Equivalent combination of education, training and experience Required
• Knowledge of clinical research process related to study startup and medical terminology High
• Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members High
• Excellent organizational and interpersonal skills High
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities High
• Ability to manage multiple competing priorities within various clinical trials High
• Ability to work independently, prioritize and work with a matrix team environment is essential High
• Working knowledge of MS Project, Word and Excel is required High

If you're looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.