Overview

We are seeking a Research Nurse to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities

• Manage clinical protocols by assembling and preparing the study team; oversee compliance to protocol; develop and adhere to relevant SOPs; manage the quality control, completion and submission of study related documentation; prepare, submit and maintain IRB, FDA, and/or other regulatory documents and research correspondence.
• Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants including determine subject population availability, develop informed consents and screening materials, screen and recruit subjects, schedule visits, obtain informed consent and oversee study visits.
• Provide a wide range of nursing assistant duties as well as being responsible for basic clerical and office automation duties.
• Measure and record basic physiological data such as temperature, pulse, respiration, and blood pressure.
• Upon patient's admission, take vital signs, orient patients with the clinic, and assist them with discharge procedures.
• Collect, measure, weigh, and ensure safe handling and delivery of various specimens in accordance with prescribed protocols.
• Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.
• Compile, edit, type weekly projected census admission lists and extract required patient statistics from the Medical Information System (MIS) database.
• Assist with recruitment volunteers for all protocols, and collect and report census for all open protocols.
• Review and abstract medical information from medical history, medications and preexisting conditions for new participants.
• Organize research information for clinical projects and develop advertising plans for open studies.
• Screen and review consents with volunteers and review follow up forms with volunteers.
• Assist the Federal Task Leader in developing clinical protocols including the evaluation of feasibility and budget.
• Manage study budgets, and track budget expenses and billing for relevant services.
• Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study.
• Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues.
• Develop and maintain study subject databases; manage data collection and management including the collection of source documents, using and developing CRFs, and ensuring that they are complete and accurate.
• Track and coordinate the collection, processing, shipment and storage of biospecimens.
• Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations.
• Assist Federal Task Leader and study team with the execution of clinical trials and assures that all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met/exceeded.
• Interview, screen and recruit patients for entry onto protocols.
• Obtain informed consent/assent and addresses complex ethical and legal implications of same.
• Provide information to clinic staff regarding Investigator Brochure information, protocol implementation, general and specific data collection and research practices.
• Collaborate with many of the following professionals and/or organizations: pharmacy, laboratories, pharmaceutical agencies/sponsors and monitors, and the Institutional Review boards and IND holders.
• Perform quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.
• Assist with the collection, processing and handling of laboratory samples including appropriate storage and shipping as needed.
• Conduct educational presentations to nursing units, clinics and other departments collaborating on NIAID clinical trials.
• Report data to appropriate regulatory and monitoring agencies. Anticipates and creates database/case reports to meet protocol needs.
• Prepare for and coordinates site visits made by sponsors or study monitors during and at the close of the study.
• Assist with scheduling and organizing patient visits to NIH as needed.
• Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.
• Build and maintain excellent communication with Federal Task Leader and others needed to conduct quality research to foster an excellent reputation of site research.
• Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the electronic data capture system and electronic regulatory binder in timely fashion.
• Obtains medical records, and review medical records for enrollment eligibility. 

Qualifications

• Registered nursing license required – Maryland.
• Minimum of 5-6 years professional clinical experience with adults is required.
• Experience as a clinical research nurse is preferred.
• Experience working in an interdisciplinary environment such as a university hospital or research hospital like the NIH CC is preferred.
• Effective communication skills working in a team atmosphere.
• Experience handling confidential material and adhering to data security and confidentiality requirements.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.