Clinical Research Associate (MPS)
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Apply Now Application ends in 27d 14h 32min
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
- Assist in the development and editing of study-related materials (e.g. consent forms, study binders, site study aids)
- Assist with preparation of training workshops, Investigator/Advisory Board meeting materials
- Assist with all phases of clinical trial activities (e.g. start-up, conduct, and close-out)
- Develop study tracking tools (e.g. site lists, enrollment tracking, vendor spreadsheets)
- Maintain tracking spreadsheets/databases and provides routine reports/dashboards to study team members
- Request PO independently, may review invoices with oversight from Clinical Project Manager (CPM)
- Track essential documents and maintain/review the eTMF under the guidance of CPM.
- Assist 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
- May attend co-monitoring visits or other site visits based on experience and training provided by and under guidance of CPM or designee
- Assist the CPM with the review of clinical database and management of flow of data, including but not limited to facilitating resolution of queries
- Assist 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)
- Assist with filing and management of the Electronic Trial Master File (eTMF)
- Distribute meeting agendas, prepare and distribute final meeting minutes including documentation of action items
- May assume a specialized administrative role (e.g. SOP Administrator)
- Travel up to 5% of the time is required
- 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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- Bachelors degree required; scientific discipline or related healthcare field is strongly preferred
- Minimum 1 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting)
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations, GCP/ICH R2
- Demonstrate core understanding of medical terminology or clinical trial activities
- Must have working knowledge and understanding of clinical protocols, and all other associated study related documents
- Advanced knowledge of MS Office including Word, Excel and Power Point and Outlook
- 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 relationship management with the cross-functional team and external vendors skills
- Clear and concise verbal and written communication skills
- Strong attention to detail and organizational skills required
- Ability to establish priorities, excellent sense of urgency to manage multiple tasks and deadlines
Apply Now
Application ends in 27d 14h 32min