Senior Clinical Trials Nurse

We are currently searching for a Senior Clinical Trials Nurse to support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and is onsite in Bethesda, MD.

• Collaborate with program team to perform clinical trial activities evaluating pain control agents and/or other driven clinical protocols to achieve the departments research objectives.
• Participates in research participant recruitment.
• Participates in screening potential research participants for eligibility.
• Obtains all appropriate outside records to support prior history, treatments, and eligibility and sends to NIH Medical Records Department.
• Facilitates the initial and ongoing informed consent or assent process.
• Collaborates with the interdisciplinary team to create and communicate a plan of care that allows for safe and effective collection of clinical research data.
• Contributes to the development of case report forms.
• Develops study-specific materials for research participant education.
• Participates in the setup of a study-specific database. Manages study-specific electronic database.
• Coordinates research participant study visits.
• Facilitates scheduling and coordination of study procedures.
• Provides direct nursing care to research participants (Example: interact with research participants to provide nursing care, administration of research interventions, specimen collection, follow-up calls, etc.).
• Provides education to research participant and family research study participation, participant’s current clinical condition, and/or disease process.
• Monitors research participant and report potential adverse events to a member of the research team.
• Records research data in designated data systems.
• Participates in the identification and reporting of research trends.
• Collaborates with Protocol Navigator to maintain accurate and complete regulatory binder.
• Participates in accurate and complete IRB submissions.
• Participates in quality assurance initiatives (respond to queries, assist with attribution of adverse events, attend weekly meeting with data management staff, and respond to monitoring and auditing reports.
• Participates in study initiation, monitoring and close out visits.
• May participate in other clinical trial duties as assigned.
• Other clinical duties as assigned to complete departmental goals.
• Assists in providing resolution to participant inquiries and concerns.

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• Bachelor’s degree in Nursing with current state nursing licensure.
• Must be CPR certified or certifiable
• Minimum of two (2) years recent nursing/clinical experience.
• Professional knowledge of the principles, theories, techniques, and practices of nursing with immunologic illnesses.
• Experience in a clinical research environment.
• Working knowledge of biological principles and scientific methods.
• Knowledge of clinical research data collection and clinical data report preparation.
• Knowledge of ICH GCPs.
• Prior experience in a clinical trials management preferred.
• Strong computer skills.
• Strong communications skills, both oral and written.
• Excellent analytical, organizational and time management skills.
• Ability to participate in efforts to ensure scientific quality and human subjects’ protection.

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

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