Research Nurse

Guidehouse•Rockville, MD

29d•Onsite

About The Position

We are currently searching for a Research Nurse to support clinical research through participant coordination, data collection, and regulatory oversight. This is a full-time, on-site opportunity in Rockville, MD. Monitor integrity, completeness and timeliness of clinical data collection. Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues. 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. 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. Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations. Recruit, screen, consent, and coordinate participants for clinical research studies and trials. Conduct clinical assessments, collect medical histories, and support patient safety and clinical care activities. Ensure protocol compliance, human subjects protection, informed consent, and regulatory adherence. Review adverse event safety datasets, serious adverse events reports, external safety reports, and protocol deviations to ensure participant safety, data integrity and regulatory compliance. Manage IRB submissions, adverse event reporting, protocol amendments, deviations, annual reviews, and regulatory documentation. Oversee clinical trial operations, participant recruitment and retention, data collection, quality assurance, and study progress monitoring. Perform clinical data management, analysis, interpretation, and reporting to support research objectives and regulatory requirements. Develop and maintain study documentation, standard operating procedures, and trial tracking systems. Collaborate with multidisciplinary research and clinical teams to improve processes, resolve complex issues, and enhance study performance. Train and mentor research staff, clinicians, and trainees on protocol implementation, regulatory requirements, and research best practices. Contribute to protocol development, literature reviews, study design, amendments, and implementation of new clinical research initiatives.

Requirements

Registered Nurse from an accredited associate's or bachelor's nursing program.
At least FOUR (4) years of experience.
Experience in clinical data management.
Familiarity with IRB and clinical research regulatory requirements.
Ability to work with stakeholders at all levels of the organization.
Must be able to obtain and maintain a Federal or DoD “public trust”; candidates must receive approved adjudication prior to onboarding with Guidehouse.

Nice To Haves

NP, PA or MD degrees also considered, practicing license not required.
Excellent writing and problem-solving skills.
Ability to obtain complete Good Clinical Practice training.
Candidates with an active public trust or suitability are preferred.

Responsibilities

Monitor integrity, completeness and timeliness of clinical data collection.
Problem-solve complex or unpredictable situations and improve processes and services to patients and colleagues.
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.
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.
Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations.
Recruit, screen, consent, and coordinate participants for clinical research studies and trials.
Conduct clinical assessments, collect medical histories, and support patient safety and clinical care activities.
Ensure protocol compliance, human subjects protection, informed consent, and regulatory adherence.
Review adverse event safety datasets, serious adverse events reports, external safety reports, and protocol deviations to ensure participant safety, data integrity and regulatory compliance.
Manage IRB submissions, adverse event reporting, protocol amendments, deviations, annual reviews, and regulatory documentation.
Oversee clinical trial operations, participant recruitment and retention, data collection, quality assurance, and study progress monitoring.
Perform clinical data management, analysis, interpretation, and reporting to support research objectives and regulatory requirements.
Develop and maintain study documentation, standard operating procedures, and trial tracking systems.
Collaborate with multidisciplinary research and clinical teams to improve processes, resolve complex issues, and enhance study performance.
Train and mentor research staff, clinicians, and trainees on protocol implementation, regulatory requirements, and research best practices.
Contribute to protocol development, literature reviews, study design, amendments, and implementation of new clinical research initiatives.

Benefits

Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Parental Leave
401(k) Retirement Plan
Group Term Life and Travel Assistance
Voluntary Life and AD&D Insurance
Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
Transit and Parking Commuter Benefits
Short-Term & Long-Term Disability
Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Care.com annual membership
Employee Assistance Program
Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
Position may be eligible for a discretionary variable incentive bonus