We are currently searching for a 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
- Acts as regulatory expert, responsible for staying abreast of applicable research regulations and policies, including training and dissemination of relevant updates to research staff and at the research groups.
- Serves as a Protocol Navigator for NIAID programs as assigned, assuring all documents for regulatory bodies (e.g. IRB, FDA, RSC, etc.,) are prepared in a timely fashion.
- Provides support to the Genetic Immunotherapy Section gene therapy and transplant program for tasks related to regulatory support for planning, review and conduct of clinical protocols.
- Manages the regulatory requirements of multiple trials simultaneously.
- Assists in the design of protocols, including but not limited to protocol writing and editing (including format and addition of administrative sections); provides and elicits input concerning the impact on available resources.
- Assists in preparing and submitting clinical protocols and/or amendments to protocols and/or adverse event reporting to the Institutional Review Board (IRB).
- Assists in assembling and maintaining records of pre-clinical study outcomes data and other information such as manufacturing information about gene therapy vectors that are required for inclusion in regulatory documents such as IND submissions to the FDA and registration documentation submissions to the NIH Institutional Biosafety Committee (IBC).
- Creatively problem solves clinical trial problems of logistics, manpower, and studies execution; appropriately identifies areas that need to be managed by the Principal Investigator (Pl) or another person within the study team.
- Responds to the request from the study team or supervisor for protocol information related to this role.
- Is recognized as an expert in the specialty area, serving as consultant to all health disciplines both within the institution and outside the NIH.
- Serves as Associate Investigator on research studies.
- Knowledgeable in safe handling and delivery of various specimens in accordance with prescribed protocols.
- Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.
- Compile, edit, type weekly projected census admission lists and extract required patient statistics from the Medical Information System (MIS) database.
- Assist in medical documentation.
- Abstract medical information from medical history, medications and preexisting conditions for new participants.
- Obtain medical records from primary care physicians and review medical records for enrollment eligibility. Review and prepare participant charts and record lab results for all new enrollments.
- Bachelor’s degree in a related scientific discipline.
- Minimum of three (3) to five (5) years' experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research, regulatory support or other related field (such as quality assurance monitoring; human research subject protection work.)
- Strong communications skills, both oral and written.
- Excellent analytical, organizational and time management skills.
- Licensed as a Nurse in the State of Maryland.
- Must be able to be credentialed by the NIH 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.
- Specific training in protocol regulatory management such as taking the coursework for the Certification program of the Society of Clinical Research Associates’ Certification Program (SOCRA Certification) or equivalent regulatory/good clinical practice training is highly desirable, though not required.
- Prior regulatory experience in support of gene therapy, cell therapy and/or bone marrow transplant clinical trials is desirable, though not required.
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.