Registered Nurse (51935)
GAP SOLUTIONS INC·Montgomery County, Maryland
GAP SOLUTIONS INC·Montgomery County, Maryland
The Registered Nurse will support clinical observational studies and trials within the Autoimmunity and Mucosal Immunology Branch. Key duties include managing patient recruitment, ensuring regulatory compliance, and coordinating data acquisition and reporting.
Participate in recruitment and outreach activities and contribute to recruitment strategies through innovative ideas. Design and maintain a selection of materials appropriate to send to health care referral sources seeking eligibility information or other objectives. Provide information about the study to referring physicians, advocacy groups, NIH offices, and in response to inquiries from potential study participants. Manage clinical and research support activities to ensure patient safety and address the clinical needs of the patients. Ensure informed consent process and human subjects protection in clinical research and counsel patients regarding the potential risks. Collaborate with researchers and medical staff to obtain and maintain informed consent and assent and address ethical and legal implication of the research protocol. Contribute to all study related IRB and regulatory matters, including all reporting requirements (including deviations, unanticipated problems, adverse events) and report issues and variance promptly to the research team. Collect and report data to appropriate regulatory and monitoring agencies. Coordinate various activities to ensure proper and filing of serious adverse events, amendments, annual reports, and other regulatory documents. Prepare documentation and track and report regulatory and institutional protocol requirements and resolve all stipulations from protocol oversight groups. Participate in data analysis and management as well as manuscript preparation and presentation of findings. Support the general implementation, tracking, data acquisition, collection and reporting of all elements of the protocols. Provide expertise in clinical trial coordination and management of data acquisition. Review adverse event safety datasets, serious adverse events reports, external safety reports, and protocol deviations to ensure participant safety, data integrity and regulatory compliance. Monitor activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials. 4 Participate in clinical practice and research support meetings and develop multidisciplinary performance improvement programs and projects to improve operating procedures, patient care and decrease costs. 3 Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues. 2 Monitor integrity, completeness and timeliness of clinical data collection 1 Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations. 5 Organize and facilitate the training program and teach physicians, physicians in training, nurses and other staff. Mentor health care members in the execution of trials and resolution of logistical constraints and update team members of changing directions in study implementation. Provide training to clinic staff with regard to Investigator, brochure information, protocol implementation, general and specific data collection and research practices. Participate in the design and implementation of current and future protocols and studies. Survey the medical literature for background information on specific aspects of the diseases under purview. Design, implement and evaluate complex protocols and manage challenging patient populations and assist with document preparations and processes. Work with staff on drafting of new protocol amendments and associated documents by providing editorial support and expert opinion. Monthly status reports to include information on current and completed activities; problems encountered; corrective actions taken; and recommendations for the next reporting period. Report should be sent to the NIAID CMC Contracts Team and the Task Leader every month and include: Hours worked: Status reports to assess progress, as requested by the Task Leader. Quarterly Report sent to COR, due within 15 days of the end of the reporting period, that includes the following for each specific contract employee for every month; a. Overtime b. Travel expenses c. Visa expenses d. Occupational Health expenses e. Quarter 1 (Oct 1 – Dec 31) Quarter 2 (Jan 1 – Mar 31) Quarter 3 (April 1 – Jun 31) Quarter 4 (Jul 1 – Sept 31) QualificationsBasic Qualifications: MD, RN, PA, or NP (practicing license not necessary) Experienced in Current Good Clinical Practice training Experience in clinical data management Familiarity with IRB requirements Excellent writing skills
Ability to communicate effectively, orally and in writing, with non-technical and technical staff Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law. This position is contingent upon contract award.
Candidates must hold a degree as an MD, RN, PA, or NP and have experience in Current Good Clinical Practice and clinical data management. Strong writing skills and familiarity with IRB requirements are essential.
Market context
In Maryland, nursing openings that require an RN and outpatient care experience are typically competitive because employers often want candidates who can step into ambulatory workflows with limited onboarding. Strong applicants usually show familiarity with patient education, care coordination, and fast-paced clinic settings. Review the AI-summarized requirements and benefits on this page to save time, then compare your outpatient experience to the core duties before applying.
