Clinical Research

• Execute the procedures of the research protocol.
• Safeguard the integrity of study data.
• Actively participate in the screening, recruitment, and retention of clinical trial participants.
• Reconcile research billing, payments, and invoices.
• Manage supply and equipment inventory levels.
• Schedule logistics, determines workflows, and secures resources for defined clinical research trials.
• Serve as an initial point of contact for clinical research participants and clinical staff, providing information regarding research procedures, expectations, and inquiries.
• Ensure participants follow the research protocol and alert Principal Investigator of issues.

Clinical Research Coordinator I/II

• plan, develop, and direct clinical research operations within the department
• provide strategic and operational oversight for clinical research programs
• oversee clinical trial operations
• ensure regulatory compliance
• supervise research staff
• manage budgets and research portfolios
• support development and submission of grant proposals and protocols
• collaborate with investigators, sponsors, regulatory bodies, and institutional partners

Clinical Research Manager

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• Support the coordination and management of operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time and in compliance with department procedures, applicable regulations and quality standards
• Participate in the preparation, review and implementation of study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, vendor management plans and other essential clinical study documents
• Support planning and management of systems and materials required to support the execution of clinical studies
• Maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management
• Support study database development by reviewing and contributing to case report form (CRF) design, user acceptance testing (UAT), and CRF completion guideline development
• Support sample management activities including planning, sample handling, kit supply management, sample shipping, sample processing, and resulting
• Support the identification, selection, start-up and performance monitoring of clinical research sites
• Support site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools
• Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensures compliance with study plans such as the study protocol, monitoring plans, and recruitment plans
• Conduct monitoring activities as needed
• Assist in the closure of studies including planning & facilitation of database lock, site & IRB/EC closure, statistical analysis and clinical study report development
• Support the management and oversight of vendors providing support to clinical studies
• Provide proactive communication, coordination, and support to sites and members of the cross-functional study team
• Actively participate in various team meetings
• Interact with investigators and site staff, vendors, key opinion leaders and consultants
• Support ongoing study audit readiness and participate in internal or regulatory authority audits
• Provide guidance and support to less experienced team members
• Participate or may facilitate department or project initiatives under the direction of management or a lead clinical trial manager
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Support and comply with the company’s Quality Management System policies and procedures
• Maintain regular and reliable attendance
• Ability to act with an inclusion mindset and model these behaviors for the organization
• Ability to work designated schedule
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day
• Ability to work on a computer and phone simultaneously
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel
• Ability to attend off-site meetings and conferences as needed

Clinical Trial Manager – CTM

• Develops and implements internal quality control processes to ensure calendar and budget builds reflect accurate trial information and comply with research billing rules
• Performs Medicare coverage analysis for complex research studies to promote and confirm compliance with billing rules and regulations.
• Works with study teams to ensure compliance
• Interprets complex clinical trial protocols while applying expertise in research billing rules, clinical workflows, sponsor requirements and electronic system capabilities to configure and review study calendars and budget setup for clinical trials
• Oversees research billing compliance activities to ensure unit is in full compliance with institutional, regional, and federal research billing compliance rules and regulations.
• Advises researchers related to proper set up and execution of billing activities for patients on clinical trials
• Provides training and resources related to research billing to study teams
• Provides expert guidance when issues arise during reconciliation of unit patient charges to ensure appropriate billing.
• Identifies and implements changes in clinical trial protocol calendar set up as needed

Clinical Research Billing Compliance Specialist

• Supports and initiates a wide variety of clinical research activities including informed consent, monitoring compliance with research protocols and regulatory requirements, coordination of therapy- and research-related care, and the collection, recording, reporting, and dissemination of research and program information.
• Areas of focus include maintaining knowledge of research protocols, patient/family education, compliance with internal and external requirements for human subject research, and education of physicians, advanced practice providers, nurses, and clinical research staff.
• Functions with demonstrated expertise and advanced knowledge in the delivery of direct and indirect nursing care to children, adolescents, and young adults clinical trials.
• The Translational Research Unit (TRU) Research Nurse will provide nursing coordination and oversight for TRU research protocols that take place both in the TRU clinic and inpatient setting.
• The TRU nurse will help coordinate nursing research activities for the TRU team to ensure consistent patient care and oversight throughout the study.

Clinical Research jobs in Wisconsin

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Clinical Research Coordinator I/II

Clinical Research Manager

Clinical Research Comm Specialist III

Clinical Trial Manager – CTM

Clinical Research Billing Compliance Specialist

Clinical Research Nurse