Clinical Research Study Manager Jobs in Silver Spring, MD

The University of Maryland, Baltimore (UMB), Center for Vaccine Development and Global Health (CVD)brings together more than four decades of innovative and life-saving research on vaccines and infectious diseases. The CVD is looking for aContractual Clinical Research Nurseto join our team. This is a Full-Time, Contractual position. Benefits: Contingent Category II UMB offers acomprehensive benefits packagethat prioritizes wellness, work/life balance, and professional development, along withadditional exciting perksthat employees can take advantage of. Contingent Category II staff receive a generous leave package that includes over 2 weeks of vacation each year, paid holidays, sick time, and time for community service; subsidized comprehensive health insurance and supplemental retirement options; professional learning and development programs; limited tuition remission for employees enrolled at UMB; life insurance and long-term disability; and flexible work schedules and teleworking options (if applicable per job). *UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland. * Primary Duties: * Manages operations of one or more research studies or clinical trial protocols requiring the expertise and care of a Registered Nurse. Instructs and counsels patients in research procedures, administers treatment procedures, monitors patients during procedures, and analyzes patient data. Develops and tracks workflow policies, recruitment strategy, and progress through the duration of the research study or clinical trial. Collaborate with Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials. Reviews and recommends proposed research study and clinical trial protocols to evaluate factors such as sample collection process, facility location, data management plans, and potential subject risks. * Recruits research and clinical trial subjects. Interacts with subject participants that include eligibility screening, recruitment, and enrollment. Ensure informed consent is properly secured and documented, counseling, and obtaining patient medical history. Serves as a patient advocate throughout the research study or clinical trial. Develops and conducts patient and family education. * Instructs and counsels patients in research procedures and administer treatment procedures. Manage patient care in compliance with the research study or clinical trial protocol requirements. Monitors subject condition while ensuring safety and maintaining confidentiality. Identifies patient problems and makes adjustments to care plans. * Develops, recommends, and implements policies and procedures and/or methods of clinical research to meet changing needs and requirements and enforce standards. Performs Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPAA) protocol development and ensure compliance of research operations with protocols and all relevant local, federal, and state regulatory and institutional policies. * Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Responsible for developing and producing custom and routine reports. Conducts quality assurance audits on data and regulatory documentation. Identifies protocol problems, informs investigators, and assists in problem resolution efforts. Recommend modifications and adjustments to care plans. * Administer and implement treatment procedures or drugs, monitors and studies their effects, and conducts subject medical evaluations. Obtains biologic tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts. * Manages the collection of complex research study or clinical trial data. Develops methods for collection, database storage, tracking, analysis, and interpretation of data. Prepares study and research related documentation. * Assist in monitoring study, clinical trial, or unit budget and compliance. May identify potential research study and clinical trial opportunities. Assist in writing research grants, publications in medical and nursing literature, study materials, brochures, and correspondence. * Serves as a liaison to other departments, outside organizations, government agencies, and sponsors to promote effective and efficient operation and use of resources. Attends research study or clinical trial related meetings, conferences, and teleconferences, as well as participating in any additional planning and development related activities. * Provide guidance and direction to staff engaged in clinical research or trials to ensure compliance with protocols and overall clinical objectives. Continuously educates and trains personnel on compliance and protocol. * Perform other duties as assigned. *Education:*Bachelor's degree. Preference in Nursing or other discipline appropriate to the position. *Experience:*Three (3) years’ experience nursing, clinical, or in a relevant research specialization related to the position. *Supervisory Experience:*N/A *Certification/Licensure:*Current Maryland license in good standing issued by the Maryland Board of Nursing to practice as a registered nurse or a multistate licensure privilege to practice as a registered nurse in Maryland or appropriate federal district licensure where research is conducted. *Other:*Certification from Association of Clinical Research Professionals or Society of Clinical Research Associates preferred May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation. Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted. Knowledge, Skills, Abilities: Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery. *Hiring Range: $87,000 - $97,000, Commensurate with education and experience * UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification. If you anticipate needing a reasonable accommodation for a disability under the Americans with Disabilities Act (ADA), during any part of the employment process, please submit aUMB Job Applicant Accommodation Request. You may also contactleave_and_accom@umaryland.edu Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address. The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read theUMB Notice of Non-Discriminationfor more information. Job: *Reg or CII Exempt Staff Organization: *School of Medicine Title: *Contractual Nurse, Clinical Research * Location: null Requisition ID: 260000QI