Protocol Nurse Coordinator (Cardiology) (NCI) Job in Maryland (MD), Research and Development - cGMP Career, Full Time Jobs in Leidos Biomedical Research, Inc.
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Protocol Nurse Coordinator (Cardiology) (NCI) job in Bethesda Md

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Leidos Biomedical Research, Inc. jobs
Maryland (MD), Bethesda Md
Job Code:  655697
Employer:  Leidos Biomedical Research, Inc.
Category:  Research and Development - cGMP
Job Type:  Full Time

Location
Country:  United States
State:  Maryland (MD)
City:  Bethesda Md
10/11/2018

Description
Description

PROGRAM DESCRIPTION

Within the Leidos Biomedical Research Inc.'sClinical Research Directorate, the Clinical Monitoring Research Program (CMRP)Directorate provides high-quality comprehensive and strategic operationalsupport to the high-profile domestic and international clinical researchinitiatives of the National Cancer Institute (NCI), National Institute ofAllergy and Infectious Diseases (NIAID), Clinical Center (CC), NationalInstitute of Heart, Lung and Blood Institute (NHLBI), National Institute ofArthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center forAdvancing Translational Sciences (NCATS), National Institute of NeurologicalDisorders and Stroke (NINDS), and the National Institute of Mental Health(NIMH). Since its inception in 2001, CMRP's ability to provide rapid responses,high-quality solutions, and to recruit and retain experts with a variety ofbackgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI,NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of theprogram and its repertoire of support services. CMRP's support services arestrategically aligned with the program's mission to provide comprehensive,dedicated support to assist National Institutes of Health researchers inproviding the highest quality of clinical research in compliance withapplicable regulations and guidelines, maintaining data integrity, andprotecting human subjects. For the scientific advancement of clinical research,CMRP services include comprehensive clinical trials, regulatory,pharmacovigilance, protocol navigation and development, and programmatic andproject management support for facilitating the conduct of 400+ Phase I, II,and III domestic and international trials on a yearly basis. These trialsinvestigate the prevention, diagnosis, treatment of, and therapies for cancer,influenza, HIV, and other infectious diseases and viruses such as hepatitis C,tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases andconditions; parasitic infections; rheumatic and inflammatory diseases; and rareand neglected diseases. CMRP'scollaborative approach to clinical research and the expertise and dedication ofstaff to the continuation and success of the program's mission has contributedto improving the overall standards of public health on a global scale.

The Clinical Monitoring Research ProgramDirectorate supports the mission of the Cardiovascular Intervention Programwithin the Cardiovascular Branch of the NHLBI Division of Intramural Researchfor development of new catheter-based treatments for cardiovascular disease inadults and children for testing in a pre-clinical setting and at collaboratingmedical centers.

KEYROLES/RESPONSIBILITIES

The Protocol Nurse Coordinator(Cardiology)III:

  • Coordinates and manages a portfolio of clinicaltrials, providing support to streamline processes needed for optimum protocolimplementation across various sites
  • Facilitates early discussions amonginvestigators, research teams and statisticians to ensure processes aremutually understood and acceptable to all
  • Orchestrates meetings with investigators andother key medical staff to identify required support to carry outwell-controlled clinical trials
  • Works directly with investigators and studyteam members on the production and revision of clinical research protocols andInformed Consent Forms (ICFs) and facilitates the activities of writing andregulatory review with bi-directional dialogue and feedback
  • Coordinates with site investigators andcoordinators regarding enrollment, adverse event (AE) assessment anddocumentation and evaluation of CRFs
  • Oversees site coordinator data entry inapproved clinical databases
  • Obtains informed consent and determines studyeligibility for subjects to be enrolled in NIH/NHLBI conducted studies
  • Reviews AE and adverse device effects todetermine attribution to the device
  • Assists sites in evaluating the AE or anypossible unanticipated adverse device effect (UADE) and communicates with thePI when there appears to be a concern
  • Works in a cath lab collecting documentationand data as well as collecting blood samples, etc. for individual studies
  • Coordinates activities related to tracking andmanagement of AE, UADEs, and protocol deviations, providing summary reports tothe regulatory team
  • Ensures incoming and historical documents areorganized and filed appropriately and that the Investigator and Sponsor'sregulatory record is complete and in compliance with FDA regulations, guidance,policies and procedures
  • Provides consultation and assistance tocomplete protocol lifecycle requirements (e.g., continuing review applications,bioethics reviews, protocol amendments, applicable Data Safety Monitoring Board[DSMB] reviews), FDA Annual Reports, regulatory binder maintenance)
  • Ensures activities are conducted in a timelymanner and in accordance with NIH policies and guidelines, as well asapplicable IDE regulatory guidelines
  • Assists staff to ensure human subjectsprotection
  • Assists research staff in navigatingrequirements from various NIH departments for research collaboration approvals
  • Attends onsite in-person meetings and providesmeeting minutes when necessary
  • Participates in the multi-disciplinary reviewof clinical research study documents
  • Serves as a liaison for investigators and otherclinical regulatory staff providing regulatory guidance, review and expertiseto ensure documentation conforms to applicable regulations device andguidelines
  • Adheres to standard operating procedures forquality control and monitors quality assurance standards
  • Assist in the collection and review of study-specificdocumentation for each protocol submitted under an IDE
  • Participates in interactions with regulatorydesignees and agencies on defined matters as needed


Qualifications

BASIC QUALIFICATIONS

To be considered forthis position, you must minimally meet the knowledge, skills, and abilitieslisted below:

  • Possession of a Bachelor's degree from anaccredited college or university according to the Council for Higher EducationAccreditation. (Additional qualifying experience may be substituted for therequired education)
  • Foreign degrees must be evaluated for U.S.equivalency
  • In addition to the educational requirements, aminimum of eight (8) years progressively responsible nursing experience,including supervisory experience
  • Possession of a current professional license asa Registered Nurse (RN) from any U.S. state
  • Knowledge of clinical trial concepts, practicesand project implementation, with an understanding of project management, datacollection/requirements, clinical data report preparation, regulatory and qualityassurance procedures and ICH guidelines
  • Must be CPR certified or certifiable
  • Ability to communicate effectively, orally andin writing, with both non-technical and technical staff
  • Must be detail-oriented and possess strongorganizational/planning skills and the ability to prioritize multipletasks/projects
  • Working knowledge of DHHS 45 CRF 46, ICH/GCPsand 21 CFR 812
  • Experience working in a data management settingin the capture and analysis of patient data, including toxicity assessment,drug administration and laboratory results as they relate to the diagnosis andtreatment of Cardiovascular diseases
  • Knowledge of the principles, theories,techniques and practices of nursing as it pertains to cardiovascular illnesses
  • Knowledge of the related disciplines ofinterventional cardiology or cardiovascular surgery or structural heart diseaseprogram coordination clinical medicine and biostatistics
  • Ability to work independently and totroubleshoot unexpected problems that may arise during the conduct of clinicaltrials
  • Must be able to obtain and maintain a securityclearance


PREFERRED QUALIFICATIONS

Candidates with thesedesired skills will be given preferential consideration:

  • Prior experience as a nurse, nurse practitioneror technologist in interventional cardiology, cardiovascular surgery orstructural heart disease program coordination
  • Masters preparation in nursing, research, or arelated discipline
  • Prior experience in adult and pediatricclinical trials management
  • Ability to operate word processing andspreadsheet applications independently with accuracy and speed
  • General knowledge of biological principles andscientific methods


Leidos is a global science and technology solutions leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company's diverse employees support vital missions for government and commercial customers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.
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