Study Startup Specialist I Job at PSI CRO, United States

b29RdWcwS205OUZJTlpQOUVRWm9HQTBsSHc9PQ==
  • PSI CRO
  • United States

Job Description



PSI is a leading Contract Research Organization with more than 28 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

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/or 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.

Job Tags

Full time, Contract work, Work from home,

Similar Jobs

Internship Positions at Global Atlantic Financial Group

Senior business intelligence analyst Job at Internship Positions at Global Atlantic Financial Group

 ...modern software, proven expertise, and world-class data and intelligence. It enables companies to optimize talent and diversity...  ...(3 in 2 WFH). POSITION SUMMARY: The Senior Business Intelligence Analyst will play a transformational role in reporting. This role... 

SecureO

Intern - Cyber Security Job at SecureO

 ...Security Analyst Responsibilities: Monitor computer networks for security issues. Investigate security breaches and other cybersecurity incidents. Install security measures and operate software to protect systems and information infrastructure, including firewalls... 

Milwaukee Area Technical College

Public safety dispatcher Job at Milwaukee Area Technical College

 ...our team who shares the same passion in serving this purpose. Learn more about MATC at . Under supervision of the Manager, Public Safety, answers emergency and non-emergency calls; dispatches resources in compliance with public safety and fire procedures; operates... 

Aveanna Healthcare

Aveanna Healthcare Private Duty Nurse RN - Full Time Nights! Job at Aveanna Healthcare

Join a Company That Puts People First!Registered Nurse - RNWe are one of the largest private duty nursing companies in the nation and growing! At Aveanna, we're proud to foster a workplace culture that celebrates diversity, encourages connection, and supports our team...

Recovery Unplugged

Behavioral Health Technician Job at Recovery Unplugged

 ...abuse treatment centers across the United States and is headquartered in Fort Lauderdale, Florida. We are currently seeking Behavioral Health Technicians for our outpatient facility in Charleston, SC. Responsibilities: Build rapport and maintain open communication...