Clinical Trial Assistant
This is an exciting opportunity for an experienced Clinical Trial Assistant to join a late development stage, public specialty pharmaceutical company focused on rare and orphan diseases. We are looking for the best and brightest talent to join our dynamic team. If you’re looking to be a part of a rapidly growing company with an unwavering commitment to improving patients’ lives and a great place to work, we hope you’ll explore our career openings and learn more about Acasti.
The Clinical Trial Assistant could be working remotely or on a hybrid work model.
About the Opportunity
The Clinical Trial Assistant (CTA) will provide support to the Clinical Study Manager (CSM) and the clinical research/drug development members in the management of all aspects of clinical trial activities for the assigned project(s), in accordance with GCPs, ICH/FDA guidelines and regulations, Acasti Pharma SOPs and SOPs of the selected Contract Research Organizations (CROs) responsible for the conduct of clinical trial(s).
Specific Responsibilities Include:
- Assist the CSM in proactively managing project level operational aspects of clinical trial(s)
- Assist the CSM in leading study start-up processes
- Maintain tracking logs of study conduct progress and completion (e.g., subject recruitment/visits/completion status, adverse events, etc.)
- Contribute to the writing and review of protocols and amendments, study plans, clinical study report and other clinical research documents (e.g., Investigator Brochure) and related regulatory submissions
- Assist in maintaining electronic or/and paper project files to include regulatory filings contracts, confidentiality disclosure agreements, manufacturing records, all research-related documentation,
SOPs, budgets, meeting related agendas and minutes, etc.
- Assist the CSM in the management of study budgets, contracts and payments to CROs and investigators
- Provide support to the internal team
Required Candidate Profile:
- BSc. degree in life or medical sciences, with a minimum of 3 to 5 years’ industry experience, or an equivalent combination of education and experience.
- Excellent interpersonal skills, strong written and verbal communication (English mandatory and
French an asset)
- Able to identify areas of opportunity and addressing possible shortfalls promptly and effectively.
- Service oriented approach, flexible and proactive towards changing needs.
- Works precisely according to procedures, rules and regulations, including HCP compliance, has a passion for continuous improvement and quality.
- Demonstrated proficiency in required software (MS Word, Excel, Outlook, Project, Power Point) and computer skills.
Acasti is a specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. Acasti’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery—all which could help to increase treatment compliance and improve patient outcomes.
Acasti’s three lead clinical assets have each been granted Orphan Drug Designation by the U.S. Food and
Drug Administration, which provide the assets with seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti’s lead clinical assets target underserved orphan diseases: (i) GTX-104, an intravenous infusion targeting Subarachnoid Hemorrhage (SAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull; (ii) GTX-102, an oral mucosal spray targeting Ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily affects children, causing severe disability, and for which no treatment currently exists; and (iii) GTX-101, a topical spray targeting Postherpetic Neuralgia (PHN), a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus
(shingles), which may persist for months and even years. For more information, please visit: https://www.acasti.com/en
Job Types: Full-time, Permanent
- 8 hour shift
- Day shift
- Monday to Friday
- Bachelor’s Degree (required)
- industry: 3 years (required)
- English (required)
Work Location: Remote
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