Study Startup Specialist II - Global Trials

Emmes; Rockville (MD); On-site; USD 65,000 - 90,000; Full time

Job summary

Emmes Group in Rockville, MD is seeking a Study Start-Up Associate II to provide administrative support for regulatory submissions on international clinical trials. You will create trackers, assist with startup activities, and coordinate with cross-functional teams to keep projects on track.

The role emphasizes attention to detail, strong regulatory knowledge, and the ability to manage multiple site activations while maintaining quality and compliance.

Qualifications

• Bachelor's Degree in a healthcare-related field required.
• Master's degree healthcare related field preferred.
• 1–3 years in pharma/CRO, preferably 1–2 years in study startup.
• Knowledge of clinical research processes related to study startup.
• Strong written and verbal communication to study personnel and sponsor teams.
• Excellent organizational and interpersonal skills.
• Ability to manage multiple priorities across trials.
• Proficiency with MS Project, Word and Excel.

Responsibilities

• Create MS project files to establish study start up timelines by country.
• Work with team on preparation of regulatory submission packages.
• Track and follow up on missing documents.
• Prepare and submit regulatory applications to authorities and IEC/IRB.
• Coordinate activities related to submissions, amendments, and safety reporting.
• Track regulatory documents and assist in coordination.
• Assist with translation coordination for contracts across EU.
• Coordinate with sponsor to secure authorization of regulatory documents.
• Maintain up-to-date tracking for each site in study trackers.
• Interact with study team on status, communication, and deliverables.
• Work to study timelines and escalate challenges; update Lead as required.
• Maintain quality and regulatory compliance among investigational sites.

Skills

Strong communication

Organizational skills

Interpersonal skills

Independent work

Multitasking

Education

Bachelor's Degree Healthcare related field

Master's Degree Healthcare related field

Tools

MS Project

Microsoft Word

Microsoft Excel

Job description

Emmes Group in Rockville, MD is seeking a Study Start-Up Associate II to provide administrative support for regulatory submissions on international clinical trials. You will create trackers, assist with startup activities, and coordinate with cross-functional teams to keep projects on track.

The role emphasizes attention to detail, strong regulatory knowledge, and the ability to manage multiple site activations while maintaining quality and compliance.