Research Analyst

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain up-to-date documentation in CTMS and eTMF systems
• Support and track site staff training and maintain compliance records
• Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
• Support subject recruitment and retention efforts at the site level
• Oversee drug accountability and ensure proper storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist in tracking site budgets and ensuring timely site payments (as applicable)
• Collaborate with cross-functional partners including CTAs, LTMs, and CTMs

Senior Clinical Research Associate

• 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

• Design, build, and maintain surveillance logic against Medicare claims data.
• Develop and refine statistical thresholds and decision rules.
• Manage surveillance data feeds — CMS claims refreshes, provider taxonomy data, eligibility events, post-acute episode chains.
• Review flagged patterns, apply documented decision rules, and document findings.
• Build and maintain benchmark adjustment models quantifying financial impact on ACO shared savings position.
• Develop and deliver operational flags to care management and network teams.

Senior Program Research Associate

• 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

• Research criminal records in jurisdictions throughout the United States
• Report results according to Validity's formatting standards
• Ensure compliance with the Fair Credit Reporting Act
• Compile information from various research sources
• Follow local, state, and federal laws in reporting records
• Liaise with the Quality Assurance team

Research Specialist – Full-Time

• 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

• Support the development of project plans and timelines for successfully completing research projects
• Document project goals, deliverables, and timelines
• Communicate and work collaboratively with other staff
• Contribute to study design and development of evaluation plans
• Develop survey and focus group instruments
• Engage with study participants for recruitment, information sharing, and data collection
• Execute survey data collection processes
• Conduct simple analyses in Stata to support the research projects
• Write project reports, policy briefs, and memos
• Prepare presentations for clients

Research Associate – Prenatal-to-3 Policy Impact Center

• Supports the execution of registered and non-registered clinical studies for products addressing medical needs and/or commercial opportunities.
• Assists in the review and interpretation of clinical investigation results to support regulatory and product development activities.
• Helps manage operational aspects of clinical trials in collaboration with project teams, ensuring compliance with SOPs, GCP, and country-specific regulations; may support clinical trial budget activities.
• May assist with clinical supply operations, as well as site and vendor selection.
• Contributes to regional or country-specific activities, including: Representing Medtronic from a clinical research perspective and gathering feedback from local customers and regulatory authorities.
• Building and maintaining effective relationships with internal and external stakeholders.
• Supporting local evidence dissemination and awareness efforts.

Associate Clinical Research Specialist

• Act as site study coordinator conducting informed consent process as designated.
• Assist with protocol submissions for review by federal or institutional committees as applicable.
• Develop, maintain, monitor, and/or share assigned/relevant documentation.
• Perform data abstraction, collection, and entry to support clinical research.
• Prepare submission for all reportable events.
• Prepare detailed data reports as required.
• Provide patient care, education, and management as applicable.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.

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