Study Startup Specialist I
PSI CRO
Study Startup Specialist I
PSI CRO
Applications Closed
Posted about 2 months ago
Full Time
,
Fully Remote
Smart Summary
The Study Startup Specialist I supports all processes critical for site activation and provides operational support to project teams to ensure smooth and timely startup of clinical projects. Responsibilities include maintaining tracking systems, assisting with site documents, and providing updates to relevant functions.
We are seeking a Study Startup Specialist with at least 1 year of experience in clinical research and study startup. The role requires strong communication, organizational skills, and the ability to build relationships. A college/University degree or equivalent experience is required.
Must Have Skills for ATS
Communication Skills
Organizational Skills
Negotiation
Relationship Building
Clinical Research
Study Startup
Feasibility Research
Site Identification
Project Tracking
Administrative Support
IRB Submission
Documentation
Audit Preparation
Job Description
Company Description
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
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.
Home-based in the United States
You will:
- 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 a minimum 1 year of Study Startup experience
- Communication and organizational skills
- Ability to negotiate and build relationships at all levels
Additional Information
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
PSI CRO
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
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