Clinical Trials Research Nurse Practitioner
We are currently searching for a Clinical Trials Research Nurse Practitioner 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
- Assists Investigator and study team with the execution of clinical trials and assures that all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met/exceeded.
- Assists study team with the evaluation of patients on the natural history protocol and summarizes and discusses history, past and present clinical evaluations that include, imaging studies, lesional biopsies and immunological evaluations with clinical team.
- Schedules and organizes patient visits to NIH as needed including international patients. Provides independent telemedicine consultations consistent with the contractor’s individual clinical credentials, Clinical Center policies and specific clinical guidance by the task leader specific to protocol requirements.
- Documents clinical and interim history of patients in CRIMSON and conducts in person and virtual protocol visits (telephone and virtual TCs) to collect structured data on natural history protocol and on clinical trials.
- Assists with collection and entry of safety and efficacy data and enterable laboratory data into databases maintained by the team.
- Interviews, screens and recruits patients for entry onto natural history and interventional protocols including international patients who require interpreters.
- Obtains informed consent/assent and addresses complex ethical and legal implications of same as back up for study nurse.
- Works with study coordinator to oversee compliance to protocol by developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence.
- Assists the study coordinator in providing training to clinic staff with regard to Investigator Brochure information, protocol implementation, general and specific data collection and research practices.
- Collaborates with many of the following professionals and/or organizations: pharmacy, laboratories, pharmaceutical agencies/sponsors and monitors, and the Institutional Review boards and IND holders.
- Performs quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.
- Assists with the collection, processing and handling of laboratory samples including appropriate storage and shipping as needed.
- Conducts educational presentations to nursing units, clinics and other departments collaborating on clinical trials.
- Reports data to appropriate regulatory and monitoring agencies. Anticipates and creates database/case reports to meet protocol needs.
- Monitors study enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits.
- Maintains study subject databases; supervises data collection and management including the collection of source documents, using and developing CRFs, and ensuring that they are complete and accurate.
- Prepares for and coordinates site visits made by sponsors or study monitors during the course of and at the close of the study.
- Contributes to developing educational materials and educate the community and other research professionals regarding studies and related research issues.
- Uses advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues
- Minimum of an R.N. and N.P. degree.
- Licensed as a nurse in the State of Maryland.
- Must be able to be credentialed by the Clinical Center.
- Knowledge of environmental safety, including infection control, isolation technique, aseptic technique, and general security.
- Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient’s medical records
- Knowledge of federal regulatory requirements pertaining to clinical research
- Knowledge of Good Clinical Practice (GCP)
- NIH clinical trials experience preferred
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.