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.
Duties & Responsibilities
- 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.
- 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.
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