Clinical Research Associate

Interius BioTherapeutics Is Seeking a Clinical Research Associate

Responsibilities:

Study Oversight

• Communicate and interact with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to clinical study manager; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
• Review and track study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
• Assist with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
• Perform regulatory document review and approval for IP release.
• Review/create/track trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
• Assist with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
• Monitor processes for distribution and tracking of SAE’s, safety documentation, and pregnancies.
• Collaborate with data management to resolve queries.
• Conduct/oversee completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP/ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study.
• Prepare telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study.
• Verify study documents (e.g., case report forms, source documents, and adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Review and track comments of monitoring reports generated by CRO as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities in conformance to the clinical trial protocol, company SOPs, GCP/ICH Guidelines and all applicable regulatory requirements.
• Assist with effective and timely audit/inspection responses.
• Perform Sponsor Site Visits as part of Sponsor Oversight of Vendor Clinical Site Monitoring activities in conformance to the clinical trial protocol, company SOPs, GCP/ICH Guidelines and all applicable regulatory requirements.
• Reconcile clinical supplies and drug accountability records
• Oversight of investigator site payments, as applicable.
• Assist in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings) and will prepare accurate and complete meeting minutes for various meetings.
• Identify and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
• Review, clarify and obtain, data changes via query resolutions with site personnel.
• Conduct monitor training.

Vendor Oversight

• Participate in vendor evaluations, selection, and start-up to ensure all vendors meet study and regulatory requirements.
• Review and provide input on study plans developed by the CRO from study award through study close-out.
• Oversee CRO CRA and site performance, ensuring compliance to SOW and within KPI’s
• Escalate any risks to major study milestones and monitor overall study site health and performance to timelines and budget.
• Participate in system set-up, user acceptance testing, and go live for electronic systems (CTMS, EDC, IXR, eTMF, etc.).
• Implement appropriate systems, standards and processes to ensure quality at the level of the investigative sites.
• Assist in preparation of vendor requirements and project scope to effectively manage study interactions with study team, sites, and vendors.
• with Data Management and Biostats to ensure expectations, timelines, data set expectations are provided to ensure sites will meet the timeline for safety review meetings and topline results.

Quality Oversight

• Ensure compliance with all quality plans, SOPs, and work instructions.
• Apply quality control at each stage of data handling to ensure data are reliable and processed correctly.
• Contribute toward development and implementation of processes to ensure studies are managed and have oversight within robust regulatory and operational framework.
• Collaborate with key vendors and investigative sites to maintain audit and inspection readiness.
• Utilize quality management to identify critical processes and data; identify, evaluate, review, control and

Qualifications:

• BS / MS Degree in Business, Life Science, engineering or related field
• 2-4 years of experience as clinical research associate
• Experience in small molecules, biologics, and/or vaccines required. Experience with cell and gene therapy preferred.
• Experience within clinical operations function including study and project management experience ideally in N. America, EU, and AsiaPac.
• Strong experience in site management and oversight of clinical studies and teams across multiple phases of development.
• Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply globally.
• Strong scientific, operational and regulatory expertise.
• Ability to communicate effectively, including with therapy area experts and patient advocacy groups.
• Possess a startup mindset of no job too big or too small
• Exceptional analytical and problem-solving skills
• Strong business etiquette and diplomacy
• Ability to operate in a fast paced, deadline sensitive environment
• Ability to work comfortably under pressure and adapt to changing priorities and deadlines
• Ability to think strategically with strong business judgment
• Able to operate independently
• Excellent verbal and written communication skills