Study Startup Specialist I

PSI CRO; United States; On-site; USD 45,000 - 60,000; Full time

Job summary

PSI CRO is seeking an individual to take their career to the next level by engaging in study startup processes in the United States. The role involves providing direct operational support to project teams, ensuring clinical projects commence smoothly and on time.

The ideal candidate will possess a college degree, at least one year of experience in clinical research or Study Startup, along with strong communication and organizational skills. This position does not support work visa requirements.

Qualifications

• At least 1 year industry experience in clinical research.
• Minimum 1 year of Study Startup experience.
• Equivalent combination of education, training, and experience.

Responsibilities

• Supports all processes critical for site activation.
• Maintains project‑specific tracking systems and electronic Trial Master File.
• Provides administrative support with site agreements and budgets.
• Assists with site documents collection for IRB/IEC submission.
• Provides progress updates to all concerned functions.

Skills

Communication skills

Organizational skills

Negotiation skills

Relationship building

Education

College/University degree or equivalent

Job description

Take your career to the next level and be involved in study startup processes in the US. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.

Responsibilities

• Supports all processes critical for site activation.
• Supports Feasibility department with feasibility research and site identification process.
• Maintains project‑specific tracking systems and electronic Trial Master File (eTMF) throughout study startup phase.
• Provides administrative support with site agreement and budgets.
• Assists with site documents collection for IRB/IEC submission and/or IP‑RED process.
• Provides progress updates to all concerned functions.
• Identifies project‑specific issues and escalates as outlined in the project specific Communication Plan.
• Supports preparation of study dossiers to sites and competent authorities.
• Supports preparation of IP‑RED packages.
• Ensures exchange of information and documentation with investigational sites, off‑site facilities and vendors throughout study startup phase.
• Additional responsibilities may include collecting documents in preparation for audits on a country‑region level.

Qualifications

• College/University degree or an equivalent combination of education, training and experience.
• At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience.
• Communication and organizational skills.
• Ability to negotiate and build relationships at all levels.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.