- Oversight of SSU activities from receipt of a potential site list to site activation under the direction of a SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements
- Implementation of the SSU Strategy for assigned region during the study start up period
- Projecting site activation timelines and appropriately escalating when things get off track
- Adhering to process and tools designed to the support of the SSU team with day-to-day activities
- Leading the preparation of study level essential document templates
- Aiding in the preparation of content for Regulatory submissions
- Handling ICF negotiations and facilitating any required escalations
- Preparation and submission of IMP Release Packages
- Maintaining accurate and timely information in relevant clinical systems
- BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience.
- Must have knowledge of clinical trial conduct
- General knowledge of drug development and ICH/GCP guidelines
- Requires proven project management skills
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Fluent in English.
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Learn more about our EEO & Accommodations request here.
Skills Required
- BS/BA degree or Associate degree with at least 2 years of healthcare or direct clinical trial experience
- Knowledge of clinical trial conduct
- General knowledge of drug development and ICH/GCP guidelines
- Proven project management skills
- Excellent interpersonal, written, and verbal communication skills
- Administrative skills and computer proficiency
- Fluency in English
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
