Job Title: Sr. Clinical research Associate (Sr. CRA)
Reports to: CPM or Associate Director/Director, Clinical Operations
Location: Raleigh, NC
This office based position is a key part of the support and management matrix for home-based site monitoring team members. Other duties and assignments as required for the overall success of studies. Duties may change based on the current status of clinical programs and current company needs.
Independently manages the study start up activities for multi-center, US and/or global based studies.
Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs.
Independently creates project specific documents and tools e.g., Monitoring Guidelines, Meeting materials/study manuals, tracking spreadsheets/databases, training tools/materials, etc.
Mentor and coach junior staff new to Clinical Research; CTAs
Assists with the development of new studies, including protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents
Authors or participates in the review and finalization of project specific plans (e.g. Clinical Monitoring Plan, Data Management Plan, TMF Plan, Vendor Management Plan)
Perform site monitoring visits (feasibility, SIV, IMV, Close-Out) and site management activities to assess the sites ability to effectively and continuously conduct the trial per the protocol, GCP, and regulatory requirements.
Support CPMs and cross-functional representatives as required in relationship management tasks (e.g. contracts, sample management, supplies, IP forecasting, etc.) and evaluating CRO performance
Conduct co-monitoring activities to assure accurate and quality data from sites monitored by CRO
Lead or participate in vendor management activities (e.g. Central Laboratory, IxRS, and PRO)
Excellent verbal and written communication skills. Adept at balancing quality speed of work output in working with a geographically diverse team, with excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language
Experience managing large clinical studies and working with CROs
Ability to travel domestically as required approximately 35%
BS/BA, RN, or equivalent with at least 5 years clinical trial monitoring / clinical trial management and vendor management experience in accordance with CFR, GCP and ICH Guidelines, proficiency with Microsoft Office (Excel, Word, PPT, etc.)
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics is a clinical-stage biopharmaceutical company founded to address the unmet medical need in food allergy, which currently has no approved treatments. Our mission is to improve the lives of people with food allergies, based on our proprietary desensitization treatments in development. Aimmune’s lead investigational drug, AR101 for peanut allergy, is in Phase 3 clinical testing in North America and Europe. The company also plans to begin clinical testing of its investigational drugs for egg allergy and walnut allergy. Headquartered in Brisbane, California – the heart of San Francisco’s biotechnology hub – Aimmune has additional offices in the Kings Cross area of London and in Raleigh, North Carolina.