Project Coordinator

Posted 16 hours ago

This is a fully remote position, open to applicants in Canada, +1 more country.

πŸ“‹ Description

β€’ Assist in the complete execution of clinical trials

β€’ Create, maintain, and assess project-specific timelines from the time of project award to archival

β€’ Address study-related issues, evaluate their urgency and impact, and escalate them as needed

β€’ Engage in communication with sponsors, clinical sites, vendors, and members of the cross-functional study team

β€’ Organize, support, and document both internal and external project team meetings

β€’ Monitor decisions, action items, follow-ups, and issues that require input from project management or leadership

β€’ Assist in the creation, review, and upkeep of project-specific documents and plans

β€’ Develop, maintain, and manage Trial Master File documentation along with study records

β€’ Identify gaps in documentation and drive the process to resolution

β€’ Collaborate with Quality Assurance and project team members to ensure compliance with GxP and regulatory standards

β€’ Coordinate start-up activities with vendors and external sites

β€’ Aid in submissions to institutional review boards and regulatory bodies

β€’ Take part in Lessons Learned meetings and offer suggestions for process improvements

β€’ Keep track of risk items or maintain a risk register

β€’ Organize project-specific training documentation and highlight any missing or delayed training inputs


⛳️ Requirements

β€’ Completion of High School Education or higher

β€’ Proficiency in MS Word, Excel, OneDrive, OneNote, Outlook, and PowerPoint

β€’ Capability to read and interpret technical documents and industry-specific manuals

β€’ Skill in writing advanced reports and formal correspondence

β€’ Ability to effectively communicate in front of groups of customers or employees within the organization

β€’ Exceptional verbal and written communication skills

β€’ Strong interpersonal skills

β€’ Personal and professional integrity with a proven ability to handle confidential information discreetly

β€’ Capacity to build strong, trusting relationships to garner support and achieve outcomes

β€’ Proficient in managing multiple conflicting priorities

β€’ Must be self-motivated, proactive, and willing to identify and anticipate client needs while making implementation recommendations

β€’ Fluency in English is a mandatory requirement

β€’ Ability to function in a French-speaking work environment in Quebec


🏝️ Benefits

β€’ Health/Dental/Vision Insurance Plans

β€’ 401(k)/RRSP with Employer Match

β€’ Paid Vacation and Holidays

β€’ Paid Sick and Bereavement Leave

β€’ Employee Assistance & Telehealth Programs

β€’ Training & Development Programs

β€’ Employee Referral Bonus Program

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