Research Analyst

• 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

• function as an expert in the field of risk analysis
• perform security reviews and produce written and oral reports identifying risk
• support compilation and analysis of data
• conduct risk-based security reviews on non-U.S. Government personnel
• prepare and provide reports, analyses, and recommendations
• coordinate with stakeholders to schedule meetings and present findings.

Junior Operations 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

• Financial analysis of capital markets.
• Identify relative value in the markets and provide investment guidance.
• Establish a network of professional contacts in sector assignments.
• Provide ongoing surveillance for all investments assigned by Senior Management.
• Conduct due diligence before executing investments.
• Gain understanding of GAAP and GASB or Statutory accounting practices.
• Participate in calls with sell-side analysts and presentations.
• Prepare financial forecasts, comparable company analyses, and valuation models.
• Produce timely research on specific companies and sector-related matters.

Senior Research Analyst

• Assists in the preparation and submission of regulatory documents to the study sponsor and IRB, as required by the protocol and regulatory requirements.
• Assist in the conduct and documentation of study visits and protocol-specific testing/interviews according to the study protocol.
• Assists the research team in completing case report forms accurately and according to the protocol.

Cancer Clinical Research Specialist 1

• Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.
• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files.
• Performs all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms (CRF).
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines.
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies.
• Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings.
• Establish and maintain communications with Investigator, Sponsor and internal constituents.
• Mentorship of the clinical research process to the junior clinical research staff.

Clinical Research Specialist II, Peds Hematology/Oncology

• 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.

Clinical Research Associate II

• Create the design and optimization of text analytics models in Qualtrics Engage / XM Discover, with a focus on rule-based topic modeling, taxonomy development, sentiment, effort, emotion, and tagging standards.
• Build scalable frameworks across multiple business units, ensuring consistency, clarity, and alignment within a complex and growing VoC landscape.
• Develop and maintain taxonomy and governance, including naming conventions, rulesets, documentation, and quality controls that keep our programs aligned across teams.
• Ensure the accuracy and integrity of classification by regularly performing model audits and ongoing maintenance to improve model capture and precision rates.
• Collaborate with other members of the CX team to make sure models reflect the real experience of our customers and support key measures like NPS, CSAT, CES, Exit Survey responses, and at-risk behavior indicators.
• Partner with business stakeholders to understand their needs, gather domain knowledge, and ensure text analytics structures appropriately support product, service, and experience priorities.
• Own project timelines and execution for text analytics development across different business units, ensuring timely updates and alignment with rollout plans.
• Support the broader CX team on select research projects such as journey mapping, qualitative interviews, or deep-dive analysis.
• Create and maintain clear documentation that enables others to understand the structure, purpose, and application of models and taxonomies.

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