Sr. Clinical Trial Associate
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Apply Now Application ends in 27d 6h 46min
Job Detail
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Offered Salary 0
Job Description
What you’ll be doing:
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- Under moderate supervision, support and coordinate logistical aspects of clinical trials
- Assists in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids)
- Assists with preparation of training workshops, Investigator/Advisory Board meeting materials
- Assists with all phases of clinical trial activities (e.g. start-up, conduct, and close-out)
- Develops study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets)
- Maintains tracking spreadsheets/databases and provides routine reports/dashboards to study team members
- Requests PO independently, may review invoices with oversight from CPM
- Tracks essential documents and maintains/reviews the eTMF under the guidance of a CRA of CPM.
- Assists with management of investigational product and study supplies by ensuring the accuracy of shipments of study-related materials and collection of regulatory documents required for IP release
- Participates in co-monitoring visits or other site visits based on experience and training provided by and under guidance of the sites’ assigned Clinical Research Associate (CRA) or designee
- Assists the CRA with the flow of data, including but not limited to facilitating resolution of queries under guidance of CRA or Clinical Project Manager (CPM)
- Assists with collection, review and filing of regulatory and other essential documents from clinical personnel (e.g. site trip reports) and sites (e.g. FDA 1572 reports)
- Assists with filing and management of the Electronic Trial Master File (eTMF)
- Provides agendas, minutes, and action items for project team meetings
- May assume a specialized administrative role (e.g. SOP Administrator)
- It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives
What we’re looking for:
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- Bachelor’s degree required preferably in a scientific discipline or related healthcare field
- 1-2 years’ applicable experience preferred, in a scientific or medical field.
- Must have knowledge in reference to GCP/ICH and SOPs
- Experience working with eTMF; Veeva experience preferred
- Working knowledge and understanding of clinical protocols, and all other associated study related documents
- Familiar with basic concepts of clinical research
- Advanced knowledge of Word, Excel and Power Point
- Knowledge of the principles and practices of computer applications in database management
- Must have a high degree of customer focus toward internal and external stakeholders
- Must display strong analytical and problem-solving skills
- Strong interpersonal and collaboration skills
- Clear and concise verbal and written communication skills
- Attention to detail required
- Ability to handle multiple tasks and deadlines
Apply Now
Application ends in 27d 6h 46min