What does a Study Start Up Specialist do?

What are the Main Job Responsibilities of a Study Start-Up Specialist?

Study Start-Up (SSU) Specialists act as subject matter experts on all SSU-related activities, overseeing and leading SSU activities in collaboration with other Clinical Research professionals. They are also involved in SSU process improvement, including patient recruitment strategies. The main responsibilities of an SSU Specialist may include:

• Reviewing and negotiating investigator contracts/budgets
• Tracking the status of contracts and contract-related documents
• Coordinating 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)
• Acting as the primary contact for investigative sites during SSU activities
• Directing day-to-day workflow of assigned GSS staff in the collection and review of investigator and regulatory documents
• Maintaining up-to-date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation
• Providing logistical support to clinical trial supply coordination
• Collaborating with staff in Operational Strategy & Planning, Business Development and Operations to provide feasibility data and other relevant data
• Ensuring all SSU information and requirements are kept up to date in a central repository for project teams
• Ensuring physicians at research sites are prepared to begin studies and have all the tools they need to do so
• Developing and updating relevant training documentation, and conducting training where necessary

What are the Main Benefits of Working as a Study Start-Up Specialist?

Working in the Clinical Research industry brings with it many benefits. Not only will you be working in an industry that’s booming, but you’ll also be contributing to making a key difference in the lives of patients across the globe.

As an SSU Specialist, you’ll be collaborating with different groups of stakeholders, allowing you plenty of opportunity to meet new people, learn from specialists across the country, and grow your professional network. Work in Clinical Research can also be extremely varied, as you’ll work on studies across numerous therapeutic areas as well as on both new and existing treatments.

What Qualifications/Experience do you Need to Start a Career as a Study Start-Up Specialist?

Clinical Research Organisations (CROs) will typically look for professionals with experience working in a Clinical Research environment, preferably with experience in reviewing study contracts or budget negotiation. Experience working in contract development/negotiation in a similar field may also be accepted. Depending on the organisation, you may also need:

• University/College degree in a relevant field (e.g., Life Sciences) or a certification in a related allied health profession from an appropriate accredited institution (e.g., Nursing, Medical or Laboratory Technology certification)
• 2 years of work experience in the Clinical Research field, and a strong working knowledge of ICH and FDA guidelines and IRBIIEC regulations
• Previous Healthcare experience
• Previous experience working with investigator start-up documents and investigative sites
• Experience working with cross-functional teams
• Strong digital literacy
• Ability to analyse data to build evidence-based trial strategies
• Ability to multitask, work well under pressure, and work well in a team environment

What is the Average Salary of a Study Start-Up Specialist?

According to Glassdoor, the average salary for an SSU Specialist in the UK is £38,706. On PharmiWeb.Jobs, senior SSU roles are also being advertised with salaries ranging up to £80,000 per year, showing excellent opportunities for progression in the field.

Search the Latest Study Start-Up Specialist Jobs

You can find the latest Study Start-Up roles on PharmiWeb.Jobs here. Don’t forget to create an account and upload your CV to help recruiters find YOU, and create job alerts to hear about the latest SSU roles as soon as they’re posted.