Senior Clinical Research Nurse

Bethesda

We are currently searching for a Senior Clinical Research Nurse to provide support to the National Institutes of Health (NIH). This opportunity is a part-time (8 hours per week) position with MSC, and it is on-site in Bethesda, MD. Duties & Responsibilities Assist the Principal Investigator in developing clinical protocols including the evaluation of feasibility and budget. Successful candidate will be responsible for a large regulatory component of natural history and interventional clinical studies, which includes but is not limited to manuscript management, protocol management, safety monitoring reports management as well as adverse events reporting and the documentation related to consent visits. Conduct Safety Monitoring visits, remain updated on adverse events reporting and amend the protocol as needed. Manage clinical protocols by assembling and training the study team; overseeing compliance to protocol; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, DSMB, and/or other regulatory documents and research correspondence. Develop study budgets, and track budget expenses and billing for relevant services. Monitor study enrollment goals and initiate 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. Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study. Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues. Supervise, mentor and train new or junior research staff. Develop and maintain study subject databases; supervise data collection and management including the collection of source documents, using and developing case report forms (CRFs), and ensuring that they are complete and accurate. Execute sample collection and initial processing. Supervise and coordinate the collection, processing, shipment and storage of biospecimens. Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations. Requirements Bachelor’s degree in Business, Accounting, or a related field. Active Registered Nurse (RN) license Minimum of ten (10) years of experience in Healthcare, Biomedical or Clinical Research, or Public Health, with a focus in clinical study coordination. Experience using NIH clinical systems is required. Skilled in successful patient recruitment for various clinical studies and trials. Excellent interpersonal skills. Organized and detail oriented. Research/clinical background required. #LI-EJ1 Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire. 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.

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