Health Care | Bethesda, MD | Full Time
InGenesis, Inc. is seeking a highly qualified Registered Nurse to work at our client site the National Institutes of Health in Bethesda, MD. This is a full-time position with benefits. Hours are Monday – Friday, 40 hours per week.
- Master’s degree in Nursing or a related discipline; two (2) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
- Minimum of five (5) years of research nursing experience coordinating and organizing the needs and requirements of clinical trials research.
- Certification by either the Association of Clinical Research Professionals or the Society of Clinical Research associates.
- Familiarity with International Conference on Harmonization (ICH) documents for core clinical study reporting.
- Familiarity with FDA regulatory affairs, information flow and criteria for reporting issues.
- Experience with written IRB communication.
- Familiarity with the process of clinical protocol development.
- Expert skills in patient assessments focusing on pain measurements and phase I clinical trials
- Strong communication skills, both oral and written.
- Excellent analytical, organizational and time management skills.
- Strong attention to detail with a high level of awareness and observational skills.
- Execute and oversee a set of clinical trials evaluating a novel interventional, non-opioid pain control agent.
- Monitor and assess various responses and endpoints; exercise primary responsibility for the conduct of the clinical trials and associated regulatory filings; provide oversight of pre-and post-treatment analgesic drug use.
- Collaborate with staff on the development of policies and procedures applied to patient populations in biomedical research protocols.
- Work with staff on the development of new standards of evaluation for novel and unpredicted interventions or novel endpoints that can be objectively and/or subjectively documented.
- Collaborate with staff on standards of nursing practice in pain management and to publish and disseminate same through scientific and professional publications and presentations.
- Provide consultative services to the multidisciplinary teams relevant to all matters of clinical research issues across the department.
- Provide mentorship developing skills and expertise in pain management protocols and all aspects of clinical research.
- Serve as a resource to external academic institutions, professional agencies and community organizations, such as hospices, to provide education and/or information on clinical trials.
- Provide expertise in clinical trial coordination and management of data acquisition.
- Oversee the general implementation, tracking, data acquisition, collection and reporting of all elements of the protocols.
- Oversee documentation, tracking and reporting of regulatory and institutional protocol requirements; resolve all stipulations from protocol oversight groups.
- Coordinate health care members in the execution of trials and the resolution of logistical constraints; ensure that all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met or exceeded.
- Provide training to clinic staff with regard to Investigator, brochure information, protocol implementation, general and specific data collection and research practices.
- Implement and evaluate complex protocols in the management of challenging protocol populations; resolve all stipulations from protocol oversight groups.
- Collaborate with staff in obtaining and maintaining informed consent/assent and addressing complex ethical and legal implications.
- Direct and perform quality assurance and quality control activities as they related to protocol adherence, protocol monitoring, data collection, data abstraction and data analysis; ensure that the standard operation procedures (SOPs) reflect the highest standards of data integrity and patient safety.
- Perform and/or coordinate the collection, processing and handling of laboratory samples, including appropriate storage and shipping as per federal and institutional regulations.
- Screen and evaluate potential participants, as per eligibility criteria for study entry.
- Conduct educational presentations to nursing unite, clinics and other departments; collaborate on CC DPM and when appropriate relevant NINDS clinical trials.
- Monitor response to therapy and adjust plan of care per protocol specifications.
- Detect and observe adverse events either predicted of unexpected and trend analysis.
- Report adverse events; prepare reports to appropriate regulatory and monitoring agencies.
- Anticipate and create databases/case reports to meet protocol need.
- Competitive Salary
- Paid Time Off
- Paid Federal Holidays
- Medical, Dental, Vision Health Insurance Plans
- 401K Retirement Plan
- Life and Disability Insurance
Established in 1998, InGenesis enjoys a long history of positive government and commercial relationships with healthcare industry professionals and businesses nationwide. We are the recent recipients of an Inc. 5000 award, and dedicated to servicing our customers.
InGenesis is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.