Remote Clinical Trials Project Coordinator (Romania)

United States Digital Space LLC; United States; Remote; USD 52,000 - 75,000; Full time

Benefits offered by this job

Flexible schedule

Ongoing learning and development

Job summary

United States Digital Space LLC is seeking a Project Coordinator to support site activation activities across clinical trials. You will work with Project Managers, Clinical Trial Managers and CRA teams to ensure timely, high-quality deliverables and strong communication with clinical sites.

Responsibilities include document collection, eTMF management, meeting minutes, and training coordination, with opportunities to support ethics submissions and study file maintenance.

Qualifications

• Bachelor’s degree in a field relevant to clinical research or equivalent experience.
• Specialized graduate diploma in drug development is an asset.
• Experience in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry, an asset.
• Excellent oral and written skills in English, French is an asset.
• Excellent knowledge and competency in Word, Excel and Power Point.
• Ability to prioritize different assignments and work under pressure.
• Attention to detail and meet timelines.
• Quick learner, good adaptability and versatile.
• Strong organizational, communication, problem-solving and multi-tasking skills.

Responsibilities

• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
• Establishes site activation timelines with selected sites and coordinates activities to meet planned activation timelines.
• Communicate with clinical sites during site start-up.
• Collaborates with other functional departments to ensure alignment of activities to meet site activation targets.
• Escalates to the Project Manager risks to site activation schedule.
• Communicates directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines.
• Collects, reviews and files sites essential documents.
• Ensures essential documentation is complete and of good quality to successfully first pass review for site activation.
• Ensures that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.
• Collects and distributes documents from / to sites.
• Produces meeting minutes from project meetings.
• Maintains ADI log.
• Assigns documents for internal project-specific training and coordinates training reconciliation and documentation.
• May assist with drafting of study documents and study plans for clinical trials.
• Acts as a main point of contact for all site correspondences for non-protocol related issues.
• Assists sites with local ethics submissions.
• Assist internal and external teams with access to study-specific systems
• Assist with initiating and maintaining study files.
• Assist with assembling and shipping the Investigator’s Study File.
• Maintains project timeline dates, enrolment tracking tools, and study material inventory.
• Prepares shipments of study supplies to clinical sites, when applicable.
• Assists with preparation of Investigators’ Meeting.
• Distributes study correspondence to sites.
• Serves as in-house contact to support CRAs when traveling.
• Reviews and reconciles investigators site and vendor payments.
• Assist with project tracking activities and status reports preparation.
• Participates in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation & Corrective Action / Preventative Action preparation for project related issues.
• May perform project management duties on designated trials.

Education

Bachelor’s degree in a field relevant to clinical research or equivalent experience

Specialized graduate diploma in drug development

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

United States Digital Space LLC is seeking a Project Coordinator to support site activation activities across clinical trials. You will work with Project Managers, Clinical Trial Managers and CRA teams to ensure timely, high-quality deliverables and strong communication with clinical sites.

Responsibilities include document collection, eTMF management, meeting minutes, and training coordination, with opportunities to support ethics submissions and study file maintenance.