Research Analyst

• 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 Specialist

• Oversee the management and tracking of clinical trial data to ensure accuracy, integrity, and completeness.
• Conduct site qualification visits, site monitoring visits, and study close-out visits. Provide support to site staff during audits or inspections.
• Ensure clinical trials are conducted in compliance with protocols, Good Clinical Practice (GCP), ICH guidelines, SOPs, and regulatory standards (FDA/DEA).
• Review and manage electronic Case Report Forms (eCRFs), ensuring data is accurate and aligned with study protocols.
• Assist in the development and maintenance of Case Report Forms (CRFs) and other study-related documents.
• Provide training to site personnel on study procedures, protocols, and regulatory requirements.
• Regularly review data entered into the Electronic Data Capture (EDC) system to ensure compliance with study protocols.
• Identify, address, and escalate any study-related risks, issues, or opportunities for improvements.
• Follow up with clinical sites to ensure that data collection is progressing as planned and all required documentation is completed.
• Ensure timely and accurate management of regulatory documents and maintain compliance with regulatory requirements.
• Engage with Key Opinion Leaders (KOLs) in the medical and research communities to stay informed on scientific research and clinical data.
• Stay up-to-date with the latest developments in scientific research and clinical data relevant to Kuros Biosciences.
• Review and track clinical trial-related invoices, ensuring accuracy and compliance.
• Contribute to the creation and maintenance of project plans for clinical trials, ensuring alignment with company policies and timelines.
• Work independently to complete tasks while ensuring alignment with team objectives, timelines, and expectations.
• Expected to travel 3-5 days per month for site visits and clinical trial support.

Clinical Research Associate

• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain in-depth understanding of the study protocol and related procedures.
• Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
• Participate & provide input on site selection and validation activities.
• Perform remote and on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased
• Subjects’ right, safety and well-being are protected
• Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
• Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Supports audit/inspection activities as needed.
• Travel Requirements up to 75%.
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

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