The Clinical Project Coordinator provides support to the clinical operations team in the execution of all aspects of clinical trial and regulatory operations activities in accordance with ICH/GCPs, applicable regulations, and 35Pharma SOPs/policies.
Key Responsibilities:
- Support the clinical operations project team (i.e., Clinical Project Manager, Program Manager) and management team (i.e., Director/Senior Director/VP), in the day-to-day management of clinical projects and clinical operations management activities.
- Support the clinical operations team in coordinating, preparing, and distributing meeting agendas, meeting minutes, and presentation slides, as appropriate.
- Support the clinical operations team in tracking action items and decisions logs. Track and escalate issues (as appropriate) in a timely manner to ensure quick resolution.
- Set-up, maintain, and ensure completeness of project-specific training records.
- Manage the preparation and distribution of study supplies (ie, investigator study files, study material), as necessary.
- Distribute information to internal team members and external stakeholders (Contract Research Organization (CRO), vendors, sites).
- Maintain various tracking and reporting tools and systems needed by the clinical operations team.
- Collect, track, review, and file all sites essential documents and other required clinical documents in the electronic trial master file (eTMF).
- Communicate directly with the CROs, Clinical Research Associates, sites and other internal team members to ensure all documents required for the eTMF are collected and filed in a timely manner.
- Assist in the review of Clinical Trial Agreements and site budgets, create tracking tool to capture costs per procedures per site and site payments and verify site payment requests against visits and procedures completed in the eCRF.
- May prepare/review/update clinical study plans (i.e., project management plan, communication plan, eTMF plan, study reference manuals, study forms, etc.).
- May support any clinical and regulatory operations project activities as deemed necessary to ensure the clinical program success.
Qualifications:
- Minimum of bachelor’s degree in health sciences or related degree within life sciences or equivalent experience.
- Minimum of 2 years’ experience in clinical drug development and project coordination/management in a pharmaceutical or biotechnology company, or a CRO.
- Flexible, independent and self-motivated.
- Excellent oral and written communication skills.
- Ability to prioritize, organize, plan, and successfully execute multiple tasks and priorities simultaneously.
- An unwavering commitment to the highest quality of work, research ethics and willingness to learn.
- Demonstrated proficiency in required software (Word, Excel, PowerPoint) and other clinical systems (CTMS, EDC, eTMF, QMS) and computer skills.
Perks:
- Comprehensive group insurance plan
- Paid public transit
- Beautiful office space in Montreal’s Old Port
- Onsite yoga and healthy snacks
- A team and culture committed to learning and high performance
Contact:
Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting CPC1018” in the subject line – we are looking forward to hearing from you!
