In-house Clinical Research Associate II - CNS/Oncology

About the role

The experienced In-house Clinical Research Associate II (IHCRA) is responsible for site management tasks for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).

Responsibilities

• 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
• Conduct remote review of electronic data capture systems (EDC) CRFs for completion, logic checks, and compliance with data entry requirements/guidelines
• Aid 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
• Support sites with prescreening, screening, and recruitment
• Assist with Subject Eligibility Review tracking and provide support to the Medical Monitor, as applicable and budgeted
• Perform other duties as assigned

Requirements

• 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

Qualifications

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