Clinical Research Associate at Regenxbio

The opportunity As a Clinical Research Associate (CRA), you will be responsible for the support and coordination of the logistical aspects of clinical trial management, site management, data review & cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs. You’ll act as a pivotal point of contact for the clinical trial team and assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned.  

What you'll be doing

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

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

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