Laulima Government Solutions, LLC is looking for a qualified Clinical Research Coordinator (RN) to support the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD. RESPONSIBILITIES: a? cents Organize and prioritize all activities associated with conducting clinical and operational research studies within a military clinic setting. a? cents Review and understand research protocols, ensuring applicable regulations, and guidelines are followed. a? cents Coordinate space and supplies with appropriate personnel. a? cents Recruit volunteers for the studies, to include determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e-mail. a? cents Serve as a Volunteer advocate and associated duties. a? cents Maintain study/test article accountability and administration. a? cents Gather, prepare, and maintain appropriate information and documentation per applicable FDA regulations and ICH guidelines (eg, source and case report forms, participant rosters, SOPs, etc.) a? cents Enter required data on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary. a? cents Coordinate with external and internal monitors. a? cents Assist in training research staff on protocol-related study methods. a? cents Monitor study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally-required guidances. a? cents Able to design and create forms, reports, etc. a? cents Maintain a safe workplace, observing appropriate safety and occupational health rules and regulations. Attend safety training relative to the position and report any infractions of safety procedures to the facility Safety Officer. a? cents Other duties as assigned. REQUIRED SKILLS AND EXPERIENCE: a? cents 2 years Clinical Trials experience DEGREE/EDUCATION/CERTIFICATION REQUIREMENT: a? cents Required to be a Registered Nurse licensed to practice in the state of Maryland, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. a? cents Basic Life Support (BLS -CPR/AED) certification. DESIRED SKILLS: a? cents Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) preferred, or commitment to sit for exam during first year of employment. a? cents Commission for Case Manager Certification (CCMC) certification preferred. CITIZENSHIP/SECURITY CLEARANCE REQUIREMENTS: a? cents A Tier I background investigation will be required. Laulima Government Solutions, LLC is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 10 paid holidays. Laulima Government Solutions, LLC is proud to be an equal opportunity employer. We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees. The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, KA? "pono Government Services, and Kapili Services, Po`okela Solutions, KA? "kaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship. For additional information, please visit #Monster