Clinical Trial Coordinator

7 days ago

Quebec Province, Canada Allphase Clinical Research Inc. Full time

Do YOU want to join one of Canada's fastest growing Contract Research Organizations (CRO) that is dedicated to providing quality and service excellence to our pharmaceutical and biotechnology clients and their customers?

At Allphase Clinical Research, we continually strive to expand our knowledge base and experience by hiring talented people to further our remarkable growth. Our aim is to find the right people for the right roles to deliver services in line with industry best practices.

Accountabilities
- Coordinate, prepare, and track clinical trial regulatory and approval documentation for trial initiation, to ensure the timelines are met and the dossiers are complete according to International Key Performance Indicators (KPIs), Standard Operating Procedures (SOPs), Local Working Procedures (WPs), and Regulatory requirements (TPD).
- Maintain the trial regulatory and approval documentation to end of study, including amendments, updated IB’s, etc.
- Communicate with sites/investigators for trial related issues and documentation.
- Coordinate the process for Clinical Trial Agreements (CTAs) and clinical trial budgets according to International and client internal standards.
- Maintain integrity of the tracking tool database (used to track timelines, site information and documents collected).
- Coordinate and organize Local and International Investigators’ meetings, TA/BU meetings, and other meetings.
- Prepare various trial related correspondence, as well as binders for CRAs and sites.
- Process Investigator Notifications for Adverse Event Reporting within International timelines.
- Manage the initial set up and maintenance of the Global clinical trial administration system (if applicable).
- Act as owner for the Manage Access Program requests and follow up with requester to obtain missing information
- Obtain internal approvals and request drug shipments
- Support applicants in using the request platform
- Respond to calls and questions from requesting sites in a timely manner
- Implement closure activities post MAP treatment, including drug reconciliation
- Send Investigator brochure updates to MAP physicians
- Act as back up for other MAP clinical trial coordinators
- Manage and update relevant trackers
- Manage filing of all relevant documentation
- Fulfill other duties as required

**Qualifications**:

- Pharmacy, Nursing, Medical or Science Degree or equivalent combination of education and experience.
- Knowledge of ICH-Good Clinical Practice (GCP) and all relevant regulatory requirements.
- Experience in supporting managed access and/or clinical activities according to ICH-GCP as well as Canadian regulatory clinical trial regulations and Rx&D guidelines.
- Excellent organizational skills and attention to detail
- Self-motivated and proactive
- Above average problem-solving skills
- Strong interpersonal and customer service skills to promote effective working relationships with others
- Ability to maintain composure and function effectively under pressure
- Strives to streamline and improve processes
- Proficiency using computerized information systems, Microsoft Office Applications, and electronic spreadsheets is required
- Flexibility: work evolves constantly, and tasks are numerous (multitasking). Required to work with a variety of products / projects.
- Excellent English and French communication skills (verbal and written).

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