Research Nurse | Bethesda, MD

at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in 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 Provide identification, screening and enrollment of patients in IRB approved clinical trial protocols. Manage clinical protocols by performing study start-up, in-services, overseeing compliance to protocol; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining 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 determining subject eligibility, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, scheduling informed consent with investigators and overseeing study visits. Build and maintain excellent communication with Principal Investigators 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.

Assist with site initiation activities as well as assist with the set-up and maintenance of studies. Maintain both new and ongoing IRB processes. Submit annual IRB continuing reviews, modifications and problem reports in a timely manner. Interface with both outpatient and inpatient units for scheduling, medication administration and follow-up visits as outlined in the protocol. Coordinate evaluation and testing of referred individuals including obtaining relevant prior medical records and blood / pathological specimens.

Obtain medical records, radiological scans and pathology slides when applicable. Provide summaries of records including medical history. Prepare reports for Data and Safety Monitoring Board / Safety Monitoring Committee (DSMB/SMC), review with Principal Investigators, attend DSMB/SMC requests and respond accordingly to additional requests as needed. Maintain excellent communication with medical partners preparing summary reports of enrollment, adverse events and other deliverables as specified in protocol/mutual agreements. Prepare reports summarizing clinical and research information gained for purposes of communication with the Institutional Review Board and publication.

Assist in communication with referring and local physicians and serves as an initial point of contact for questions from patients. Interface with NIH Clinical laboratories, Contract laboratories, NIH Research laboratory personnel and outside laboratories to ensure correct and timely specimen collection and track results of testing. Track and obtain knowledge to observe and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner. Manage close-out of clinical protocol including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations.

Qualifications Registered nursing license required - Maryland. Malpractice insurance required. Experience with performing study start up and management of IND clinical trials. Effective communication skills working in a team atmosphere. Willingness and ability to work flexible hours when experimental needs require it. CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at .

CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual 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.