Senior Clinical Research Associate (Sr CRA)

What you'll be doing:

• Create, implement, and maintain systems to track study metrics and general information relating to study execution. Provides the updates to the team on metrics as needed
• Prepare trial-related documents including but not limited to Informed Consent Forms (ICF), source documents, patient instruction guides, lab manuals and Case Report Forms (CRFs)
• Reviews site-specific study documents (site-specific ICF and study tools/worksheets), and site payments
• Works closely with enablement group and clinical project manager to track study metrics including CRO and other vendor activities
• Conduct periodic review of metrics for completion of study files in the eTMF. Escalates appropriately to the CPM and study team of updates and timelines regarding file completion
• Participates in team meetings and may lead small operational teams and/or participates in collaborative efforts (e.g. Standard Operating Procedure (SOP) development, operational task forces, etc.)
• Supports Clinical Project Manager in site and vendor selection process, training and evaluation of study personnel (contractors and CRO)
• May participate in site visits as needed or accompany experienced clinical monitor for co-monitoring or training purposes
• Collaborated with internal cross functional teams to ensure effective delivery of the assigned project milestones
• Organizes internal team meetings, investigator, meeting and other trial specific meetings as required
• Support the Clinical Project Manager in the planning and organization of investigator meetings and other meetings as necessary
• Provides support to the Clinical Project Manager in the management of vendor scope(s) of work, budget updates & reconciliation, as agreed upon with prospectively established milestones and timelines
• Maintain completion of required corporate training on standard, policies and work instructions by due date
• Generate purchase orders, process vendor invoices and assist in tracking spend approved in the budget
• Performs other work-related duties as assigned
• Travel up to 25% 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 5 years clinical research experience (e.g. pharmaceutical, biotechnology, CRO healthcare setting); 2 +years monitoring experience is preferred
• Ability to work on complex or multiple projects and exercise critical thinking
• Knowledgeable in clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, as required
• Solid organizational skills, interpersonal skills and communication skills (both written and oral)
• Demonstrates problem solving skills, self-motivated and adaptable to a dynamic environment
• Strong computer skills (MS Office, Smartsheet)
• Experience in global trials preferred
• Experience in interactions with vendors (e.g CROs, central laboratories, and other vendors preferred)
• Ability to work in a dynamic, fast paced environment
• Ability to deal with ambiguity

Why You Should Apply