Clinical Trial Start-Up Lead - Onsite RTP

United Therapeutics Corporation; North Carolina; Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

United Therapeutics Corporation is seeking a Clinical Trial Specialist II to partner with global study teams for efficient study start-up. The role focuses on investigator-site liaison, essential document collection, and regulatory submissions in compliance with ICH/GCP guidelines.

You will develop study-specific manuals, templates, and coordinate ICF form customization while maintaining inspection readiness and strong cross-functional communication with CROs and site personnel.

Qualifications

• Bachelor’s degree required; 3+ years in start-up activities for clinical studies or equivalent.
• Proven experience with local regulatory submissions, IRB/IEC requirements, and ICH/GCP guidelines.
• Experience using clinical systems (SSU, eTMF, CTMS) and ability to work independently in a fast-paced environment.

Responsabilités

• Lead study start-up activities with investigator sites.
• Coordinate essential regulatory document collection and template development.
• Support site staff in local submissions and ICF customization as required.
• Maintain inspection readiness and study/site milestones across systems.
• Mentor junior staff and prepare clinical trial communications.

Connaissances

Organizational skills

Attention to detail

Communication skills

MS Office proficiency

ICH/GCP knowledge

Formation

Bachelor’s Degree

Outils

SSU

eTMF

CTMS

Description du poste

United Therapeutics Corporation is seeking a Clinical Trial Specialist II to partner with global study teams for efficient study start-up. The role focuses on investigator-site liaison, essential document collection, and regulatory submissions in compliance with ICH/GCP guidelines.

You will develop study-specific manuals, templates, and coordinate ICF form customization while maintaining inspection readiness and strong cross-functional communication with CROs and site personnel.