Registered Nurse

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) Show more Show less Be among the first 25 applicants Full-time Not Applicable Health Care Provider Public Health 101796 https://www.linkedin.com/jobs/view/registered-nurse-at-gap-solutions-inc-4439721246?trk=public_jobs_topcard-title EXTERNAL