Clinical Research

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Identify potential sites for clinical research participation
• Perform study start-up activities, including collecting regulatory documents and supporting contract and budget negotiations
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites after study completion
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed consent, safety-event reporting, and applicable regulatory requirements

Senior Clinical Research Associate – Oncology

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Identify potential sites to participate in clinical research
• Perform study start-up activities, including collecting regulatory documents and supporting contract and budget negotiations
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites once studies conclude
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed-consent procedures, safety-event reporting, and applicable regulatory requirements
• Perform most site-management efforts remotely

• Provide leadership and direction to clinical site management team members from study start through closure
• Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project
• Act as the primary sponsor contact
• Manage monitoring deliverables to achieve the study budget
• Identify out-of-scope activities

Senior Clinical Trial Manager – Oncology

• Provide a high standard of care for participants in Phase I clinical trials
• Respond to emergency situations according to clinical research standards
• Monitor clinical study sites, including routine monitoring and close-out visits
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol requirements comply with regulatory requirements
• Verify integrity of Case Report Form and other data submitted through source-document monitoring
• Monitor data for missing or implausible information
• Manage registries and conduct feasibility work when requested
• Complete Serious Adverse Event reporting, narratives, reports, and follow-up
• Perform CRF review, generate and resolve queries using Fortrea or client data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact when assigned
• Perform other duties assigned by management

Clinical Research Associate II, Phase I

• Provide a high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards
• Conduct routine monitoring and close-out of clinical sites
• Maintain study files
• Conduct pre-study and initiation visits
• Liaise with vendors
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol requirements comply with regulatory requirements
• Verify the integrity of data submitted on Case Report Forms and other data collection tools
• Monitor data for missing or implausible data
• Manage study registries and undertake feasibility work when requested
• Complete Serious Adverse Event reporting, narratives, and follow-up
• Perform CRF review, query generation, and resolution using Fortrea or client data management systems
• Assist with training new employees through co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator
• Act as a local client contact as assigned
• Perform other duties as assigned by management

Senior Clinical Research Associate II, Phase I

• Manage day-to-day clinical trial management activities, supporting the team to deliver quality outcomes
• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures
• Build and manage strong relationships with trial investigators and stakeholders
• Ensure trials comply with local, national, and international regulations and ethical guidelines
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management
• Support the team and stakeholders to deliver high-quality outcomes across clinical programmes

Clinical Trial Manager

• Provide leadership and direction to clinical site management team members from study start through closure
• Serve as Site Management’s primary point of contact and representative for clinical monitoring and site activities within the project
• Serve as the primary sponsor contact
• Manage monitoring deliverables to achieve the study budget
• Identify out-of-scope activities

Senior Clinical Trial Manager – Hematology/Lymphoma

• Obtain informed consent from patients using paper consent forms and REDCap e-consent platforms
• Request and coordinate tissue samples through Duke Clinical Laboratories for clinical trial and research requests
• Register research participants in required Duke systems
• Work with leadership to ensure compliance with Duke, state, and federal regulations
• Review IRB-approved protocols for regulatory and operational compliance
• Assist investigators and research teams with specimen-related research activities
• Participate in cross-training, including biospecimen collection and patient consenting
• Assist in identifying adverse events and protocol deviations and determining reportability
• Use patient health data from the Duke electronic medical record to identify cohorts, extract medical information, and access patient samples
• Generate abstracts based on literature searches and reviews when participating in conferences
• Ensure samples comply with CHTN quality control standards and grant milestones are met
• Train new team members and contribute to training plans, group workflows, and operational design

Clinical Research jobs in North Carolina

Senior Clinical Research Associate – Oncology

Senior Clinical Research Associate – Oncology

Senior Clinical Trial Manager – Oncology

Clinical Research Associate II, Phase I

Senior Clinical Research Associate II, Phase I

Senior Clinical Trial Manager – Oncology

Clinical Trial Manager

Senior Clinical Trial Manager – Hematology/Lymphoma

Clinical Research Coordinator