Study Start Up Specialist (with Italian)

About Alimentiv

Alimentiv is a global clinical research organization dedicated to advancing medical research. They provide comprehensive services to support clinical trials, aiming to bring new treatments and therapies to patients worldwide.

Role Overview: Site Start-Up Coordinator

This home-based role involves supporting Project Management, Regulatory, and Contract & Legal teams in all site-related start-up activities for clinical trials. You will establish key relationships with study personnel, act as the main point of contact during site initiation, manage start-up documents, and track progress using designated systems.

Role and Responsibilities:

1. Site Start-Up Packages

• Cooperate with Project Management to create study-specific start-up document packages.
• Distribute and follow up with sites to obtain required executed documents.
• Review returned documents for content and correctness according to internal standards.
• Ensure correct and complete packages are obtained within planned timelines, in conjunction with Regulatory Affairs.

2. Site Contract and Budget Negotiation

• Obtain feedback on suggested site and investigator contract language in cooperation with Contract and Legal.
• Serve as the main point of contact for sites regarding feedback on budget and contract negotiations.
• Provide sites with suggested study budgets and negotiate within pre-approved margins, in conjunction with the Project Manager.

3. Site Intelligence Tracking

• Maintain a site intelligence tracker with data on study site requirements (e.g., start-up timelines, budget, contract negotiation prerequisites, patient recruitment data).
• Provide input for suggested site lists during the start-up phase based on past site experiences.

4. Site Start-Up Planning and Tracking & Project Management Support

• Act as the main contact for study sites during the start-up phase.
• Develop and maintain relationships with study sites to facilitate timely completion of start-up activities.
• Plan start-up actions and provide expected Site Initiation Visit (SIV) dates based on previous metrics, regulatory, and IRB timelines, in conjunction with project management and CRAs.
• Track progress of start-up activities in Smart Sheet and/or CTMS.
• Maintain up-to-date knowledge and ensure adherence and compliance with local regulatory requirements and associated documentation.
• Provide support to project management with study-related activities as required.

Qualifications:

• Undergraduate university degree (Bachelor or Honors Bachelor) with minimal training (<1 year related experience); OR College Diploma/Degree with 1-3 years of related experience.

Other:

• Excellent communication skills.
• Knowledge of start-up requirements for clinical sites.
• Experience working directly with clinical study sites.
• Very high sense of urgency.
• Some financial responsibility (handling small cash floats, minimal spending limits, input for department budget creation).
• Ability to set personal pace and content for tasks.
• Large number of regular contacts requiring patience and tact.
• English and Italian language skills.

Working Conditions:

• Home-based.

Important Information:

• Phishing Scam Warning: Alimentiv only uses company email addresses ending in "@alimentiv.com". Verify sender domains carefully. Report suspicious communications.
• AI in Hiring: Alimentiv may use AI tools to assist in reviewing applications and resumes. These tools support, but do not replace, human judgment in the hiring process. Final decisions are made by humans.