Clinical Research Coordinator

Clinical Research CoordinatorBethesda, MDAxle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).Axle is seeking a Clinical Research Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Cancer Institute (NCI) located in Bethesda, MD.Position OverviewThe Contractor shall provide personnel capable of supporting complex clinical research portfolios and ensuring efficient coordination among investigators, research teams, oversight offices, regulatory agencies, collaborating institutions, and other stakeholders involved in the conduct of clinical research. Requires a Master's degree, along with preferred certifications such as SOCRA, FAC-P/M, FAC-COR, PMP, or ACRP credentials. Experience with clinical trial management systems and research databases, technology transfer or clinical trial agreements, and supporting NIH, NCI, academic medical centers, or federally funded research programs is preferred.Additional QualificationsCertifications & LicensesSOCRA CertificationFAC-P/M CertificationFAC-COR CertificationPMP CertificationAssociation of Clinical Research Professionals (ACRP)Field of StudyHealth and Medical Administrative ServicesNursingSoftwareExperience with clinical trial management systems and research databaseSkillsExperience with technology transfer agreements, clinical trial agreements, cooperative research and development agreements, or related research partnershipsExperience supporting NIH, NCI, academic medical centers, or federally funded research programsDeliverablesMonthly Activity Report — MonthlyPortfolio Status Report — MonthlyRisk Management Report — MonthlyFinancial Status Report — MonthlyRegulatory Tracking Report — MonthlyStrategic Planning Support Reports — Ad-HocAnnual Program Summary Report — YearlyFinal Contract Summary Report — Ad-HocStatement of Work DetailsCoordinate operational activities for clinical studiesAssist with feasibility assessments for proposed clinical trialsSupport startup activities for new studiesCoordinate participating sites for multi-center trialsMonitor study progress and enrollment-related metricsReviews, assesses and evaluates clinical trial design and feasibilityProvide comprehensive management and oversight of assigned clinical research portfoliosDevelop and maintain project management plans for clinical research projectsMonitor project schedules, timelines, deliverables, dependencies, and milestonesTrack portfolio performance metrics and report progress to leadershipAssist Branch Chiefs and Program Leadership in prioritization of research activitiesSupport portfolio planning and resource allocation effortsMonitor project execution to ensure alignment with organizational objectivesReviews, evaluates and analyzes clinical trial data and study informationLead development and maintenance of project-specific work plansCoordinate project initiation, planning, execution, monitoring, and closeout activitiesFacilitate project meetings and maintain meeting documentationTrack action items and follow-up activitiesMonitor project performance and identify potential barriers to successAssist investigators and research teams in achieving project objectivesReviews, evaluates and recommends logistical, procedural and operational approaches to clinical trial implementationDevelop risk mitigation and response plansMonitor identified risks throughout the project lifecycleEscalate significant issues to leadership as appropriateCoordinate corrective actions and resolution activitiesIdentify operational, regulatory, financial, and programmatic risksAssesses and supports meetings, clinical trial assessments and site visitsMonitor and coordinate activities associated with protocol development, protocol amendments, IRB submissions, regulatory submissions, continuing reviews, study activation activities, and clinical trial monitoring activitiesSupport preparation for audits, inspections, and monitoring visitsCoordinate activities among investigators, regulatory staff, data managers, and clinical teamsMonitor compliance-related milestones and deliverablesFacilitate timely submission of required regulatory documentsFormulates guiding principles and Standard Operating Procedures (SOPs), and prepares staff for clinical researchFacilitate communication among study stakeholdersAssist with development of project-specific budgetsMonitor expenditures and financial performanceTrack project funding and resource utilizationDevelop financial forecastsIdentify potential budgetary concerns and recommend corrective actionsPrepare financial status reports for leadership reviewServe as liaison between assigned research programs and the Office of the Clinical Director (OCD), NCI Technology Transfer Center, regulatory offices, collaborating institutions, industry partners, and other NIH and NCI organizationsCoordinate leadership briefings and status updatesPrepare communication materials and project summariesAssist Government personnel with development of Statements of WorkAssist with technical evaluations and acquisition planning activitiesTrack contractor performance, deliverables, and invoice statusMonitor contract milestones and option periodsSupport COR activities as requestedSupport strategic planning initiativesAnalyze program performance and operational effectivenessDevelop recommendations for process improvementsAssist leadership with prioritization of future research initiativesSupport implementation of organizational best practicesDisclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.Accessibility: If you need an accommodation as part of the employment process please contact: View email address on click.appcast.io role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.Salary Range$145,000 - $155,000 USD