Research Analyst

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits.
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Lead Clinical Research Associate

• Contributes to the selection of potential investigators
• Trains, supports, and advises Investigators and site staff in study related matters
• Performs monitoring visits (remote and onsite)
• Ensures data query resolution in a timely manner

Senior Clinical Research Associate, FSP

• Conduct original research that quantifies risk perceptions about wildlife diseases.
• Identify social correlates of grassland conservation.
• Explore variations in waterfowl hunters’ worldviews with regards to wetland and waterfowl conservation.
• Provide mentorship in social-psychological modeling, social-ecological systems, and advanced multivariate analysis to graduate students and postdoctoral fellows.
• Work in collaboration with, and report directly to, the Principal Investigator of the Human Dimensions Research Lab.
• Co-lead the broader investigation of “Social-ecological challenges at the human-wildlife interface: Coyotes, zoonotic disease and public health.

Human Dimensions Research Associate

• Manage the launching and ongoing maintenance of research studies
• Creation and maintenance of technical specifications in proprietary software for study questionnaires
• Quality check study questionnaires & perform in-depth quality checks at every stage of the process
• Liaising with our internal data collection teams, coding & data processing teams
• Perform data verification
• Identify and solve project issues as they arise

Research Analyst, Market Strategy

• Work closely with internal stakeholders, to ensure that client needs are understood and met with a variety of analytical resources.
• Provide consultative leadership and statistical direction. Communicate client needs to the director and team members.
• Lead complex research and analysis projects on key policy issues, proactively identifying areas for investigation and delivering evidence-based insights to senior executives and external partners.
• Take responsibility for analytical work in areas such as student enrolment, student success, faculty and staff workloads, university finances, and more.
• Contribute to the development and maintenance of the department’s data resources, ensuring high-quality, accessible information for strategic decision-making.

Senior Research Analyst

Research Analyst, Customer Experience

• Oversee and manage assigned clinical trial sites, conducting on-site and remote monitoring visits to ensure compliance with protocols, ICH-GCP guidelines, and regulatory requirements
• Drive the implementation of Risk-Based Quality Management (RBQM) principles to proactively identify, assess, and mitigate risks throughout study conduct
• Build and maintain strong relationships with investigators, site staff, and cross-functional teams to support efficient clinical trial execution
• Monitor site performance, recruitment progress, retention, and data collection to ensure study timelines and quality objectives are met
• Ensure patient safety and data integrity by resolving discrepancies, managing adverse events, and maintaining inspection readiness
• Provide site training and continuous support on study protocols, operational procedures, systems, and compliance requirements
• Act as an ambassador for Novo Nordisk values at the site level, ensuring high-quality trial execution

Clinical Research Associate

• Oversee and manage assigned clinical trial sites, conducting on-site and remote monitoring visits to ensure compliance with protocols, ICH-GCP guidelines, and regulatory requirements.
• Drive the implementation of Risk-Based Quality Management (RBQM) principles to proactively identify, assess, and mitigate risks throughout study conduct.
• Build and maintain strong relationships with investigators, site staff, and cross-functional teams to support efficient clinical trial execution.
• Monitor site performance, recruitment progress, retention, and data collection to ensure study timelines and quality objectives are met.
• Ensure patient safety and data integrity by resolving discrepancies, managing adverse events, and maintaining inspection readiness.
• Provide site training and continuous support on study protocols, operational procedures, systems, and compliance requirements.
• Act as an ambassador for Novo Nordisk values at the site level, ensuring high-quality trial execution.

• Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
• Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
• Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
• Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
• Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
• Develop and cultivate strong site relationships and ensure continuity of site relationships
• Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
• Identify, assess, escalate and resolve site performance or quality issues in a timely manner
• Complete feasibility and site identification activities for new clinical studies
• Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)
• Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions
• Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
• Responsible for the development of site specific recruitment, retention and follow-up plans
• Facilitate and support investigator site audits and/or inspection activities as needed
• Perform remote data review and query resolution for designated sites
• Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives
• Coach and mentor colleagues as needed
• Contribute to the review of Codera’s systems and procedures as needed
• May be involved, when needed, in other areas of study management and staff training
• Execute other duties as assigned

Clinical Research Associate, Site Director

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects
• Conduct study initiation visits (SIVs)
• Ensure compliance with obtaining informed consent and reporting potential safety-related events
• Adhere to all applicable regulatory requirements

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