Nursing Research & Informatics

Experience with Phase I-IV clinical trials and CRO partnerships (rare disease experience is a plus).. Proficiency in EDC, CDISC standards, SAS, and SQL.. Strong understanding of clinical research regulations (FDA CFR, ICH GCP).. In-depth experience with all aspects of Data Management, including CRF/database development, data quality, and vendor management.. Proficiency with clinical data coding systems (MedDRA, WHO Drug).

Expert research nurse who leads the provision of clinical care within the context of a clinical research study and helps develop studies and projects.. Exemplifies the Rush mission, vision and ICARE values and acts in accordance with Rush policies and procedures.. Relevant research certification (Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP).. Provides nursing care to patients participating in clinical research studies, may include: standard of care procedures, research procedures, study medication administration and adherence assessments, adverse event assessment documentation, blood draw, EKG administration, and various clinical assessments.. Position Clinical Research Nurse 3

This position is responsible to verify and ensure receipt of all medical records upon patients discharge, prep, scan and index the same.. Also, Health Informatics Coordinator III assists medical staff member in their chart completion effort but will carry out the suspension process if the medical staff member does not complete their records in a timely manner.. This position is also responsible to assist with submission of OSHPD data, Cancer Registry reporting, Birth Certification process for newborns, Tracking of Newborn Screening samples and results etc.. The Health Informatics Coordinator III will further support the department needs through assistance in any of analysis, Release of Information, or other duties as assigned.. Knowledge of the State and Federal Regulatory requirements for HIPAA Privacy and Security required

Business Unit: Rush Bone Marrow Transplant and Cell Therapy Center. Expert research nurse who leads the provision of clinical care within the context of a clinical research study and helps develop studies and projects.. Exemplifies the Rush mission, vision and ICARE values and acts in accordance with Rush policies and procedures.. Relevant research certification (Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP).. Provides nursing care to patients participating in clinical research studies, may include: standard of care procedures, research procedures, study medication administration and adherence assessments, adverse event assessment documentation, blood draw, EKG administration, and various clinical assessments.

This position will be based at Loyola University Chicago's Health Sciences Campus in Maywood, Illinois, but may occasionally require work at a Loyola University Medical Center satellite campus.. Under the guidance of the principal investigator (PI), the research nurse is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with good clinical practice guidelines, federal and sponsor regulations and Loyola University Policy and procedures.. Plans and implements clinical trial to include but not limited to coordination with all members/ departments/ external institutions of the study team, oversight of IRB, regulatory and /or FDA submissions, budget preparation participation, and study management tool development.. Prepares and participates in Cooperative Group Audits, NCI, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.. Consistently ranked among the nation's top universities by U.S. News & World Report , Loyola is a STARS Gold-rated institution that is ranked as one of the country's most sustainable campuses by The Princeton Review and has earned distinctions from AmeriCorps and the Carnegie Foundation for its longstanding record of service and community engagement.

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area.. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care.. Collaborates with the Dana-Farber Harvard Cancer Center DFHCC quality assurance of clinical trials office in developing protocol specific materials.. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

Inova Fairfax Hospital - Research Center - Schar Heart and Vascular is looking for a dedicated Clinical Research Nurse Coordinator 1 to join the team.. Tuition and Student Loan Assistance: offeringup to $5,250 per year in education assistance and up to $10,000 for student loans.. Mental Health Support: offering all Inova team members, their spouses/partners, and their children 25 mental health coaching or therapy sessions, per person, per year, at no cost.. Explains basic elements of subject safety including the reasoning behind the required use of an Institutional Review Board/Independent Ethics Committee, study activity documentation, and event reporting requirements.. Education: BSN or AD. If RN has an AD, within six months from date of hire, they must meet with their nurse leader and conduct the following: 1.)

The Senior Clinical Research Nurse (SCRN) works with the CommonSpirit Health Research Institute Division Manager, Clinical Research Operations (DMCR) Principal Investigators (PI), co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the CommonSpirit Health Research Institute.. Provides training and mentorship, project leadership, and ensures quality control compliance by the Clinical Research Nurse Associate and Clinical Research Nurse and/or Clinical Research Associate and Coordinator positions.. Perform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i.e., NIH Stroke Scale, NYHA and CCS class.. Serve as liaison between participants, physician investigators, sponsors of research, IRBs, CSHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.. Minimum 7 years of experience conducting clinical trials required; worked as primary research nurse for at least 20 drug or device trials.

Under the direction of the Principal Investigator or designee, the Clinical Research Nurse I is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions.. The Clinical Research Nurse I is a a member of the team and resource for study protocol conduct acting as a liaison between the SLU SOM, clinical partners (ex.. SSM Health), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study.. We currently have openers in Surgery, Nephrology, and the Cancer Center.. Maintains participant-level documentation for all studies, including those that are complex in nature, require access to the EHR or require SLUCare/SSM charge routing.

May perform duties inclusive of those delegated to a Research Nurse Coordinator I.. Facilitates and implements study start-up activities including (but not limited to): trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval.. Active Listening, Clinical Research Coordination, Clinical Research Management, Clinical Research Methods, Clinical Research Operations, Clinical Techniques, Database Management, Detail-Oriented, Effective Written Communication, Electronic Health Records (EHR), Nursing Fundamentals, Oral Communications, Patient Recruitment, Reporting Tools, Spreadsheet Software, Statistical Analysis Software (SAS), Team Collaboration. Take advantage of our free Metro transit U-Pass for eligible employees.. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Job Title: Clinical Research Nurse (Senior - Principal Level). ATLAS conducts clinical research, focusing on clinical trials, and real-world data studies in the acute care setting with a particular focus on early interventions for critically ill and injured patients.. ATLAS receives significant funding from the NIH, DOD, and CDC.. This role will engage patients, families, and clinical staff at the University of Colorado Hospital, manage study start-up and documentation for clinical trials, collaborate with clinical and research teams working to improve care of critically ill and injured patients.. Knowledge of basic human anatomy, physiology medical terminology

The Research Nurse III is responsible for providing nursing technical expertise and overall execution of phase I - III clinical trials, with an emphasis on complex cell, gene and immunotherapy trials.. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organizational policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.. Utilizes nursing education to contribute to study start-up activities, including site initiation visits, protocol review of feasibility and suggestions for revision, study and clinical staff training.. The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region.. At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).

UPMC Hillman Cancer Center is currently hiring a regular full-time Clinical Research Nurse I (RN) to help support the Clinical Research Services team located at the Hillman Cancer Center in Shadyside/Pittsburgh, PA & at the UPMC Magee Women’s Oncology Research program in Oakland/Pittsburgh, PA. This role offers a $6,000 sign-on bonus and will support various Oncology Disease Center program studies working Monday through Friday daylight hours. The Clinical Research Services (CRS) team is made up of nearly 200 staff members who facilitate the development, implementation, coordination, internal data monitoring, and completion of oncology-focused trials at Hillman. Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing. The clinical research nurse will work with physicians, nurses, other allied health professionals, and research staff to coordinate clinical research efforts provided at UPMC. Facilitates compliance with the requirements of the research protocol and good clinical research practice while remaining cognizant of the needs of the diverse patient population.

The Research Nurse Coordinator I is responsible for all activities associated with clinical study coordination, subject Screening/recruitment/enrollment, data management/integrity, regulatory compliance, project/study evaluation and interfaces with participants and family members. Coordinates the clinical logistics of the study, and works in tandem with the Research and/or Clinical Nurse who provide hands-on clinical care to research participants. Utilizes clinical nursing background and basic research protocol knowledge to serve as a liaison between nursing staff, Principal Investigator, other research staff, and study participants. Working Title : Research Nurse Coordinator I, Hybrid.. By applying, you consent to your information being transmitted by Nomad Jobs to the Employer, as data controller, through the Employer’s data processor SonicJobs.

Assist investigator in dose modifications according to the protocol.. Maintain systems for appropriate identification, recruitment, consent, and enrollment/ randomization of eligible patients on clinical research studies.. Assist with study start-up activities including but not limited to participating in pre-study visits, site initiation visits, protocol-specific training, and investigator meetings.. Assist with orientation and mentoring of research staff including clinical research coordinators, and other research staff.. Demonstrate ability to work collaboratively with other members of the team including investigators, research staff, and hospital/clinic and infusion center staff.

The Senior Clinical Data Manager (CDM) leads and coordinates Data Management (DM) deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.. This position also serves to contribute to process improvements, staff learning & development and provides input for DM services cost proposal.. · Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements.. · Perform Medical Dictionary for Regulatory Activities (MedDRA) and/or World Health Organization Drug Dictionary (WHO-DD) medical coding procedures · Participate in conference calls and/or meetings with vendors and sponsors.. · Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation) · Experience in CDISC conventions, i.e., CDASH, SDTM model and hands on experience implementing these models.

Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans.. Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC).. Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP.Strong knowledge of clinical research, drug development process, and medical terminology, oncology experience preferred.. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

The Role & DepartmentAs the Senior Clinical Data Manager, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.. The Senior Clinical Data Manager will represent Clinical Operations Data Management on the CTT, and with partners and/or Data Management/Statistical vendors.. You may support the overall strategy and development of Clinical Operations by participating in task force initiatives within the department.. Key responsibilities include:The Senior Clinical Data Manager will be part of the cross-functional trial specific CTT and be responsible for core deliverables such as clinical database design/setup, data collection, data validation, manual review, and timelines.. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

You will ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including database build and validation, data entry, data transfer, data reconciliation and review, medical coding, data freeze and database lock.. You may be required to function as lead CDM for multiple clinical trials or oversee the data management team across a collection of studies.. You will ensure that CDM documentation is filed into the Trial Master File according to SOPs and the study plans; review CDM files for completeness and accuracy.. You will assist with development of therapeutic area standards for Case Report Forms, Edit Checks, and Data Review You will assist in the coordination of the acquisition, development, and implementation of tools to support data management tasks internally; this may include development of specifications, testing plans, and data standards and helping (with the support of Sr. Management) that the entire DM department implements these tools efficiently and effectively.. You will have knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects.

Assigns diagnosis codes following the Official Guidelines for Coding and Reporting and AHA Coding Clinics to obtain an accurate working DRG.. Promotes a partnership with Coding/HIM team to ensure the accuracy of principal diagnosis, procedures, and completeness of documentation to determine the working and final DRG, severity of illness and risk of mortality, risk adjustment, HCCs, etc.. Advanced degrees such as Master, Doctorate or Foreign Medical Graduate will require proof of degree status.. CCDS or CDIP certification is required with proof of current, active certification.. IV. Software/Hardware: Proficiency in Microsoft applications, EMR applications, CDI, and coding software

Mission: To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research; person-centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community-centric researchers and healthcare professionals. Vision: To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all. A Clinical Research Nurse (CRN) supports Principal Investigators (PI) in the day-to-day activities required for activation, execution, and management of clinical research studies or protocols.. Serve as a lead research coordinator for an emerging central coordinator pool, work with leadership to lay the groundwork for expanding a coordinator pool, and overall portfolio staffing and management;. Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as well as any other mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training as required;