Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at the United State Army Medical Research Institute of Infections Disease (USAMRIID). If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.
We are currently seeking a Clinical Research Study Nurse for the Frederick, MD area.
Work involves planning, organizing and executing clinical protocols for investigational new vaccines and licensed vaccines as well as epidemiologic studies.
Will participate in the development and revision of clinical protocols.
Will provide direct nursing services (care) using the nursing process in support of research protocols.
Will provide nursing services in the treatment of occupational illness and/or accidents associated with work, which may involve exposure to highly infectious, contagious or toxic substances.
Provide direct patient care daily, using the nursing process in support of research protocols conducted by the Division of Medicine.
Ensure appropriate and accurate documentation of patient care in the medical record and in designated case report forms and specific computer programs.
Advise, perform, and instruct Division of Medicine staff, research participants and/or others about protocol-specific procedures and treatments, equipment, policies, adverse medication reactions, and follow-up instructions appropriate to the research study.
Perform and/or assist in participants’ briefings and screenings, to include obtaining of informed consent.
Based on guidance from Technical Point of Contract, will update research investigators of relevant issues, concerns, and progress of study
Provide summary report of all study activities to the Principle Investigator (PI) and Chief, Division of Medicine
Assist research investigators in collecting study data and statistics.
Assist PI in submitting final annual Continuing Review Reports (CRRs) and annual report for the study.
Assist in developing protocol-specific recruitment strategies, to include briefing slides, flyers, advertisements and phone script.
Interact with extramural sites for scheduling, consenting, and follow-up
Write and review Standard Operating Procedures (SOP) and Study Specific Procedures (SSP) and guidelines.
Ensure that studies are implemented in full compliance with Good Clinical Practices (GCP) and Department of the Army (DA) regulations, guidelines, and practices.
Quality Control (QC) of tracking and filing of all protocol laboratory test results and samples.
QC the preparation of study charts, case report forms, labels and laboratory and other test results.
QC of test article (vaccine) accountability.
QC of regulatory study file to include filing of necessary documents per protocol SOP, Food and Drug Administration (FDA) and DA requirements.
Prepares regulatory files and study records for QA audits, monitoring, etc. Assists PI in responses to audits and monitoring visits.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs light duties and other related duties as required and assigned.
Associate of Arts degree in nursing program at an accredited college OR certified completion from an accredited Licensed Practical Nurse (LPN) school of nursing and Certified Clinical Research Coordinator/Associate (CCRC) certification.
The incumbent must possess and maintain a license as a licensed practical nurse or registered nurse in the State of Maryland.
Incumbent must be GCP (Good Clinical Practice) trained.
The contractor shall possess computer skills in the following computer software programs: Microsoft Office/Word and Excel.
The contractor shall collaborate in development of the Clinical Data Management System (CDMS). Contractor shall have current BLS certification.
Contractor will have completed HIPAA training and will comply with proper handling of classified information.
Contractor will complete all required Government training required for position and/or organization.
Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
“NorthCoast 99” Best Places to Work recipient
Clinical Research Management - 17 months ago