Clinical Trials Research Nurse
We are currently searching for a Clinical Trials Research Nurse to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.
Duties & Responsibilities
- Provide study coordination, IRB and regulatory oversight, and nursing support for Investigational New Drug (IND) and non-IND interventional clinical trials being conducted at the Clinical Center and relating to the pathogenesis and treatment of rheumatic, musculoskeletal, and skin disorders.
- Assist the Principal Investigators (PIs) and clinical teams in patient care coordination, such as coordinating patient visits and protocol required procedures, data collection, including development of protocol-specific case report forms and flow sheets, assist with regulatory oversight, IRB applications, and responding to monitoring and audit report queries.
- Coordinate patient schedules, data collection and nursing care.
- Assist investigators with skilled procedures.
- Develop order sets and orders protocol-mandated tests, labs, and procedures.
- Communicate with members of the multidisciplinary team in coordination of patient care and protocol requirements (i.e., Nursing, Pharmacy, Consult Services, Fellows, etc.)
- Monitor and document drug accountability.
- Alert PIs of adverse events, abnormal outcomes, problematic trends, and protocol violations/deviations.
- Enter protocol data in database management system.
- Follow patients between visits and collaborate with referring and primary physicians.
- Assist in the creation of case report forms.
- Interface with the Institutional Review Board (IRB), study Sponsor, study monitors, data manager, and protocol manager to ensure protocol compliance and data integrity and coordinate accurate and timely filing of Adverse Events (i.e., UPs, SAEs, SUSARs).
- Assist with the writing and submission of initial protocol and consent forms, amendments, annual reports, and other regulatory documents.
- Coordinate changes to the protocol or consent documents.
- Conduct updates for clinical staff on patient care, protocol process and progress, human subject protection and ICH Good Clinical Practices.
- Assist PIs in interpreting research data for the protocol team and assist study team with results reporting to ClinicalTrials.gov in compliance with FDAAA.
- Collaborate with study staff in the drafting of study papers for submission to scientific research journals.
- Essential duties also include determining patient eligibility for participation in clinical trials and obtaining subject informed consent.
- Must have successfully completed a professional nursing program approved by the legally designated State accrediting agency.
- Must have current licensure to practice as a nurse in the state of Maryland.
- Must be CPR certified or certifiable.
- A minimum of three (3) years of experience with IND clinical trials.
- Prior experience in adult and pediatric clinical trials management preferred. Prior experience and knowledge of diseases in the NIH research portfolio: rheumatic, musculoskeletal, and skin diseases.
- Ability to perform word processing and spreadsheet applications independently with accuracy and speed.
- General knowledge of biological principles and scientific methods.
- Knowledge of clinical research data collection and clinical data report preparation.
- Knowledge of ICHGCPs.
- Experience in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, and laboratory results, as they relate to the diagnosis and treatment plans.
- Professional knowledge of the principles, theories, techniques, and practices of nursing.
- Ability to work independently and to troubleshoot unexpected problems that may arise during the conduct of these trials.
- Excellent written and verbal communication skills.
Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.