Registered Nurse

Duties And Responsibilities

• 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.
• Care for the coordination and management of 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.
• 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.
• Maintain oversight of activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials.
• 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.
• Solve complex or unpredictable situations and improve processes and services to patients and colleagues.
• Monitor integrity, completeness and timeliness of clinical data collection.
• Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations.
• 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:
• Hrs 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)
• f. Quarter 2 (Jan 1 – Mar 31)
• g. Quarter 3 (Apr 1 – Jun 31)
• h. Quarter 4 (Jul 1 – Sept 31)

Problem-solving

• Solve complex or unpredictable situations and improve processes and services to patients and colleagues.

Monitoring

• Monitor integrity, completeness and timeliness of clinical data collection.

Training

• 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.

Protocol Development

• Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations.
• 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.

Reporting

• 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:
• Hrs 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)
• f. Quarter 2 (Jan 1 – Mar 31)
• g. Quarter 3 (Apr 1 – Jun 31)
• h. Quarter 4 (Jul 1 – Sept 31)