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Job Description
Title:Clinical Site & Start Up Associate
Location:Fully Remote
Start Date:June 2024
Must haves:
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Location:Fully Remote
Start Date:June 2024
Must haves:
- Fluent in French and English
- Prior experience in study start-up
- Excellent communications skills (verbal, written, presentation) inEnglish and French. Being perfectly bilingual will be a top priority for them to communicate with our Quebec Sites.
- Demonstrate good understanding of theCanadian Regulations.This person will be the main point of contact for our US counterparts.
- Demonstrate goodorganization skills.This person will need to create new tools, work efficiently with the different internal stakeholders and have bold ideas in order to improve internal processes.
| ESSENTIAL FUNCTIONS |
| Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials in line with established targets and including communication of updates |
| Ensures proactive risk identification and mitigation planning for assigned clinical trial sites |
| Drives and tracks site activation and start-up activities with clinical trial sites to support trial start-up strategies |
| Provides system and device expertise to train and support clinical trial sites |
| Ensures ongoing collection and review of relevant documentation e.g., related to protocol amendments, site staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance with Company SOPs, relevant regulatory requirements and ICH and GCP guidelines |
| Provides support to prepare for and follow-up on audits and inspections |
| Shares information, collaborate, and provide relevant input and guidance to other areas within Company, CMR and global partners |
| Demonstrates technical proficiency within responsible areas, stays up to date on new practices systems, and technologies while building knowledge of emerging trends and advances within area |
| Contributes actively to Trial Core Team and other relevant teams |
| QUALIFICATIONS |
| A Bachelor’s degree (science-related discipline preferred) or a Registered Nurse (RN) degree is required |
| A minimum of 3 years of experience in the planning and conduct of GCP clinical trials, some of more recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare setting required |
| A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required |
| Relevant Companyexperience will apply where appropriate |
| Site activation and site management/monitoring experience is an asset |
| Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials |
| Demonstrated computer skills (MS Office, clinical trial systems) and adaptability to new systems |
| Excellent communications skills (verbal, written, presentation) inEnglish and French |