About the Opportunity
We are currently partnered with a clinical-stage Biopharmaceutical company that specializes in developing innovative cancer treatments. As the company looks to advance their robust pipeline, they are looking for an experienced Study Start-Up Specialist/Lead to join their expanding Clinical Operations team. This is a fully remote / permanent opportunity directly with a rapidly growing sponsor.
The annual base salary range is $100,000 to $125,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- The Study Start-Up Specialist/Lead is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to US regulations, Core/Site document collection/ approval, ICF customization/approval, SIV scheduling and activation requirements
- Coordinate essential documents collection with study sites in accordance with local processes
- Coordinate the Feasibility activities
- Coordinate the identification and selection of research sites
- Create, maintain/track, and obtain approval on essential study start up documents
- Assist with activities relating to identification vendors as applicable
Job Requirements
- Bachelor’s Degree with 3+ years of clinical research experience at a pharmaceutical company, Biotech or CRO
- Detailed understanding of clinical trial process across Phases I-II and ICH GCP
- Extensive knowledge of the top US oncology site’s start up process
- Ability to understand clinical protocols and associated study specifications
