Research Analyst

• Perform on-site and remote monitoring visits to ensure subject safety and data quality
• Review CRFs and source documentation for accuracy and completeness
• Ensure informed consent procedures and protocol compliance are met
• Manage and track Investigational Product accountability
• Prepare monitoring visit reports and follow up on action items
• Maintain and update eTMF, CTMS, and trial documentation systems
• Support sites with issue resolution and ensure timely completion of deliverables
• Participate in audits and inspections, including preparation and follow-up
• Collaborate with project teams and contribute to monitoring plans, project tracking, and CRA resource planning

Senior Clinical Research Associate

• Contribute to study design and methodology development
• Develop innovative approaches, frameworks and solutions to client problems
• Deliver project outputs that meet established quality standards, timelines, and budget requirements
• Conduct structured literature reviews and targeted secondary research to support RWE initiatives
• Participate in qualitative research activities, including patient interviews, to generate actionable healthcare insights
• Analyze and interpret qualitative and quantitative ‘real-world’ data for deliverables
• Conduct workshops and moderate discussions
• Present results to external clients
• Contribute to the development of: Study protocols, Technical reports, Manuscripts and scientific posters, Client presentations
• Develop and format materials using PowerPoint, Word, and Excel
• Summarize and synthesize complex clinical and outcomes data into clear, structured findings
• Support retrospective and prospective real-world studies under senior guidance
• Demonstrate openness to leveraging emerging technologies, including AI-enabled tools, to improve efficiency, analytical rigor, and personal productivity

Senior Research Associate

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP)
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• Supports subject/patient recruitment, retention and awareness strategies
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met

Clinical Research Associate – Full-Service

• Conducting thorough research into an individuals’ background using a variety of tools, such as databases and public records
• Gathering information, analyzing data, and compiling this information to be entered into a final report
• Processing searches related to background screening reports
• Ensuring all searches are processed and reported according to state and federal laws as outlined in AccuSourceHR’s reporting guidelines
• Ensuring all searches are processed according to client guidelines
• Retrieving public records information and entering said information into our platform
• Analyzing information and comparing data sets to confirm matching identifiers
• Performing other duties as assigned
• Meeting or exceeding minimum standard service requirements

Research Analyst jobs in Maine

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Senior Clinical Research Associate

Senior Research Associate

Clinical Research Associate – Full-Service

Research Specialist