In-house Clinical Research Associate II - Oncology

What you will do:

• Assist with feasibility questionnaires and CDA collection from potential sites, as requested
• Coordinate study material (e.g., CRFs, manuals) shipment and receipt by study site
• Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF) and review collected/received documents for quality in accordance with GDP and WCT SOPs prior to submission to the TMF.
• Support field CRA with maintenance of the Investigator Site File (ISF) by assisting with Trial Master File (TMF) reconciliation and providing support on TMF Quality Control Checklist (QCCL)
• Conduct pre-study, study initiation, interim and remote monitoring, and close-out visits under the guidance of the field CRA or CTM/PM, as applicable and appropriate
• Discuss and assist field CRA and/or site staff with IP inventory, as applicable and appropriate
• Maintain regular communication with sites per the Clinical Monitoring Plan and Site Management and Monitoring Plan, as needed and applicable for the assigned study
• Complete remote review of electronic data capture systems (EDC) CRFs for completion, logic checks, and compliance with data entry requirements/guidelines.
• Assist sites in the resolution of DM issued EDC queries, vendor-issued queries, etc.
• Pull reports from study-specific portals, EDC systems, etc., create or maintain study-specific trackers, and provide information to CTM for distribution to or use by the project team/sponsor.
• Provide visit preparation support for field CRAs, including but not limited to routine summation/communication of (e.g., Action Items, Protocol Deviations, EDC queries, vendor queries, study supplies, and/or pending site staff training prior to scheduled onsite visits, etc.)
• Assist with site staff changes as needed or as requested (e.g., CTMS updates, essential document collection, regulatory document collection, and review of site staff training, qualifications, and task delegation)
• Assist with vendor access management for site staff (request/revoke access)
• Support sites with prescreening, screening, and recruitment
• Assist with Subject Eligibility Review tracking and provide support to the Medical Monitor, as applicable and budgeted
• May serve as the main point of contact for operational aspects of the clinical research trial, as applicable and appropriate
• Provide mentoring and training for In-house CRA I and II
• Attend and present (if required) updates during study meetings
• Perform other duties as assigned.

What you will bring to the role:

• Good oral and written communication skills
• Good planning and organizational skills with effective time management
• Good interpersonal skills
• Ability to work in an organized and methodical manner
• Good understanding of clinical research principles and process
• Good understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements as required, training provided by WCT
• Good understanding of standard operating procedures, training provided by Worldwide Clinical Trials
• Basic knowledge of Microsoft Office
• Familiarity with IVRS, eCRF systems, and training provided by Worldwide Clinical Trials

Your experience:

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science AND
• A minimum of two years of clinical research experience (e.g., study coordinator, research nurse, etc.)
• Candidates must have experience in Oncology