What does a Study Start Up Specialist do?
SummaryWhat does a Study Start Up Specialist do?
- SSU Specialist
What is the Job of a Study Start Up Specialist:
Study Start Up (SSU) Specialists function as a subject matter expert on all SSU-related activities and their role is to oversee and lead SSU activities in collaboration with other clinical research positions. They are also in charge of SSU process improvement and patient recruitment strategies.
Job Responsibilities of a Study Start Up Specialist:
- Coordinates the delivery of the Global Site Services (GSS) component of assigned studies within a country or region. (Including overall accountability for delivery to time, cost, and quality)
- Has primary contact with investigative sites during site start-up activities
- Is responsible for directing day to day work flow of assigned GSS staff in the collection and review of investigator and regulatory documents
- Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
- Where applicable, provides logistical support of clinical trial supply coordination
- Works with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data.
- Ensures all start up information & requirements are kept up to date in a central repository for project teams
Qualifications/Experience Needed to Start a Career as a Study Start Up Specialist
- University/College degree (Life Science preferred) or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
- Not always a rule but 2 years work experience in the clinical research field and a strong working knowledge of the ICH and FDA guidelines and of the IRBIIEC regulations is expected
- Previous healthcare experience is preferred
- Previous experience with investigator start-up documents and investigative sites is preferred
- Experience working with cross functional teams
- Strong computer skills required
- The ability to analyze and review data (in order to build evidence-based trial strategies)
- Capable of multi-tasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment
Career Progression for a Study Start Up Specialist
Study Start Up Specialists have a very dynamic job and responsibilities that vary from data analysis to working with several departments at once in order to develop good strategies. To achieve his goals, a Study Start Up Specialist needs to constantly develop his personal skills (e.g. charisma, stress management) but also to reinforce his knowledge of laws, regulations, guidelines and to familiarize himself with all start-up documents. Contrary to what is apparent from his job title, Study Start Up Specialists are always useful to their companies, independent of the current phase in which their clinical research trial is.