Senior Clinical Research Associate (sr Cra)

Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The opportunity

As Sr Clinical Research Associate (Sr. CRA), you will work closely with the Clinical Project Manager and will be responsible for assisting in the planning and execution of clinical trials which includes assistance in vendor and site management, coordinating or leading data review and cleaning. You will support the CPM with oversight of the clinical study while ensuring the trial is conducted in compliance with the protocol, ICG/GCP, applicable regulatory requirements and applicable SOPs/Work instructions.

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