Freelance Regional Clinical Trial Coordinator

at  Rho

Overview:
Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.
At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.
We are currently hiring a Freelance Regional Clinical Trial Coordinator to join our team! This can be home-based in Poland, Estonia, Lithuania, or Latvia!
Our Clinical Operations team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Responsibilities:

• Supports in preparation of ISFs (Investigator Site Files).
• Contact, communication and guidance to CRA and sites as instructed by Trial manager
• Maintenance of TMF (Trial Master File) or the CRO Project File and periodically review the TMF and/or CPF to ensure accuracy, completeness.
• Upload Country and Site level documents in Veeva Vault in a timely manner.
• Timely transfer of Study documents (scanned copies) to Sponsor, as agreed, on an ongoing basis.
• Supports in preparation of documents package for submission to CA (Competent Authorities) and EC (Ethics Committee), and support for EU CTR submissions
• Facilitate the communication between stakeholders in regards to documentation management
• Provide support to stakeholders on the planning, collecting, filing, confirming, archiving of trial records, as needed
• Support the stakeholders to confirm records availability at specific timepoints, as required by Sponsor procedures
• Sponsor/ Rho team meetings preparation, drafting meeting minutes.
• Maintains tracking information for Study activities.
• Support Trial Manager on data entry and maintenance to systems (includes correction of wrong data entry)
• Supports CRA (Clinical Research Associate) in maintaining ISF at Site.
• Support sites getting access to systems, as needed
• Support Trial Manager sharing updates with sites
• Support on audits and/or inspections
• Execute other commands within the organizational structure in Rho according to the existing policies and internal procedures

Qualifications:

• Degree in medicine, pharmacy, life science or related field will be considered as advantage
• Previous experience in Clinical Trial Assistant or similar role for at least 1 year
• Excellent knowledge of English languages
• Strong organizational, communication and teamwork skills
• Accuracy and attention to details
• Computer literacy

Please submit your CV / resume in English.

• Supports in preparation of ISFs (Investigator Site Files).
• Contact, communication and guidance to CRA and sites as instructed by Trial manager
• Maintenance of TMF (Trial Master File) or the CRO Project File and periodically review the TMF and/or CPF to ensure accuracy, completeness.
• Upload Country and Site level documents in Veeva Vault in a timely manner.
• Timely transfer of Study documents (scanned copies) to Sponsor, as agreed, on an ongoing basis.
• Supports in preparation of documents package for submission to CA (Competent Authorities) and EC (Ethics Committee), and support for EU CTR submissions
• Facilitate the communication between stakeholders in regards to documentation management
• Provide support to stakeholders on the planning, collecting, filing, confirming, archiving of trial records, as needed
• Support the stakeholders to confirm records availability at specific timepoints, as required by Sponsor procedures
• Sponsor/ Rho team meetings preparation, drafting meeting minutes.
• Maintains tracking information for Study activities.
• Support Trial Manager on data entry and maintenance to systems (includes correction of wrong data entry)
• Supports CRA (Clinical Research Associate) in maintaining ISF at Site.
• Support sites getting access to systems, as needed
• Support Trial Manager sharing updates with sites
• Support on audits and/or inspections
• Execute other commands within the organizational structure in Rho according to the existing policies and internal procedure