Clinical Research Nurse

Overview

We are currently searching for a Clinical 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

• Coordinates with clinical staff to plan, implement, monitor and manage clinical protocols with Internal Review Board (IRB) requirements.
• Collaborates with clinical staff to develop and maintain trial related documents and operational procedures.
• Assists with protocol and consent development and review, including schedule of events, sample collection and laboratory testing, reporting to the IRB, and human subject protection.
• Monitors protocol compliance.
• Oversees the collection, distribution and filing of regulatory documents.
• Prepares all documents for amendment submissions to the IRB including the changes to the protocol and cover memo detailing the changes.
• Works with Investigator to ensure patient safety monitoring is completed in a timely manner.
• Recruits and screens patients for inclusion in protocols/clinical trials.
• Performs patient assessments and collects medical histories.
• Abstracts data from patient charts, medical records, questionnaires, and diagnostic tests.
• Administers protocol consents and documentation to study participants.
• Directs and performs quality assurance and quality control activities as they relate to protocol adherence and monitoring, data collection, data abstraction, and data analysis and ensures standard operating procedures reflect the highest standards of data integrity and patient safety.
• Manages databases and coordinates data collection.
• Enters patient and sample data in the appropriate databases.
• Coordinates the handling of laboratory and patient samples including appropriate storage, shipping, and tracking.
• Follows up with patients to ensure completion of questionnaires, return of samples, etc.
• Maintains all appropriate ethical and regulatory training and qualifications.
• Monitor key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens, and adherence to federal and state regulations surrounding the collection, storage, dissemination, and use of biospecimens.

Requirements

• A Degree from a professional nursing program approved by the legally designated State accrediting agency at the time the program was completed by the applicant.
• Must have current licensure to practice as a nurse in the state of Maryland.
• Must have malpractice insurance.
• Minimum four (4) years or more of education, training, and experience equivalent to a Registered Nurse/masters level to advise and serve as an authority and consultant to NIAID Investigators.
• Knowledge of the Code of Federal Regulations, International Council of Harmonization, Good Clinical Practice guidelines, Institutional Review Board guidelines, and the NIH standards for Clinical Research Practice is highly desired.
• Knowledge of the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.
• Ability to effectively communicate both verbally and in writing, including advanced interpersonal communication skills, presentation skills, and professional writing skills.
• Ability to use information technology associated with patient care and research information management.

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Company Description

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.