Clinical Research

• 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 Nurse

• Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
• Identifies work unit resources needs and manages supply and equipment inventory levels
• Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries
• Ensures participants follow the research protocol and alerts Principal Investigator of issues
• Performs quality checks
• Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training
• Contributes to the development of protocols
• Collects, abstracts, and interprets subject data from medical records or other source documents
• Records and submits subject data to study sponsors, resolves data queries, and verifies accuracy of data
• Maintains research subject charts and ensures all data elements have been accurately collected
• Schedules logistics, determines workflows, and secures resources for clinical research trials
• Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional
• Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy

Clinical Research Coordinator II

• Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries.
• Ensures participants follow the research protocol and alerts Principal Investigator of issues.
• Performs quality checks.
• Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training.
• Contributes to the development of protocols.
• May assist with training of staff.
• Schedules logistics, determines workflows, and secures resources for clinical research trials.
• Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional.
• Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy.
• Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols.
• Identifies work unit resources needs and manages supply and equipment inventory levels.

Clinical Research Coordinator I/II

• coordinate industry sponsored and internally funded prospective clinical trials across multiple investigators
• perform quality checks
• identify resource needs and develop clinical research documents
• contribute to the development of protocols
• schedule logistics, determine workflows, and secure resources for clinical research trials
• manage research workflow components, collect, prepare, process, and submit participant data and samples to appropriate entities
• serve as a main point of contact for clinical research participants
• ensure participants follow the research protocol and alert Principal Investigator of issues

Clinical Research Coordinator

• Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
• Recruits, screens, selects, determines eligibility and enrolls trial participants, collects information, and answers questions under supervision of a medically licensed professional.
• May perform basic medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy
• Schedules logistics, determines workflows, and secures resources for a defined clinical research trial(s)
• Serves as an initial point of contact for clinical research participants and clinical staff, providing information regarding research procedures, expectations, and informational inquiries.
• Ensures participants follow the research protocol and alerts Principal Investigator of issues
• Identifies work unit resources needs and manages supply and equipment inventory levels

Clinical Research Coordinator I

• Focus on specific project assignments and coordinating efforts across all study sites within two rare diseases, CADASIL and Huntington's Disease
• Coordinate projects throughout the pre- and post-award grant process
• Lead start-up efforts at research sites and regulatory duties
• Facilitate effective cross-functional communication and collaboration among project team members
• Provide timely support to resolve roadblocks for team members to achieve project and program goals
• Document specific project activities
• Main point of contact for sites and projects
• Oversee training protocol development and implementation

Clinical Research Project Coordinator I/II

• Provides focused program management services to pharmaceutical development programs.
• Acts as primary liaison and client account lead for the sponsor.
• Oversees the coordination and management of projects by monitoring project status, timelines and budgets.
• Works closely with laboratory management to ensure that the project deliverables meet customer expectations and meet PPD financial commitments.
• Provides oversight and coordination of client portfolio for high value or pivotal client account studies.
• Ensures the project requirements are understood, agreed and followed at all times.
• Facilitates the flow of technical and clinical laboratory information to all stakeholders.
• Maintains an updated study master file with version controls for specs, budgets and contracts.
• Ensures sponsors have authorized and signed off most recent versions of all docs.
• Assures compliance with FDA and Good Clinical Practice guidelines.

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