Senior Clinical Research Coordinator

Job Description - Senior Clinical Research Coordinator (2500029V)Job DescriptionSenior Clinical Research Coordinator - ( 2500029V )DescriptionThe Senior Clinical Research Coordinator independently leads the day-to-day operations of clinical research studies conducted by principal investigators with limited supervision. This role is part of the Research Coordinator Pool, supporting multiple studies across various therapeutic areas and collaborating with multiple principal investigators. The individual performs a variety of complex duties involving the collection, compilation, documentation, and analysis of clinical research data. The Senior Clinical Research Coordinator will develop a comprehensive understanding of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations. In addition to managing their portfolio of studies, the individual may support other investigators with clinical and translational research projects and may direct the work of a Clinical Research Assistant or Clinical Research Coordinator as assigned.QualificationsMinimum EducationB.A./B.S. degree in a science, technical, health-related field or other applicable discipline with at least 3 years of relevant experience (Required) OrMaster's Degree Master’s degree with at least 2 years of relevant experience (Required)Minimum Work Experience3 years At least 3 years of experience with a bachelor's degree. (Required) Or2 years At least 2 years of experience with a master's degree. (Required)Required Skills/KnowledgeKnowledge of clinical research designs and needed infrastructure.Familiarity with databases, data collection tools and data analysis methods.Ability to manage multiple complex activities while maintaining close attention to detail and not losing sight of the organizational terpersonal skills that demonstrate formal and informal leadership in a diverse professional environment.Required Licenses and CertificationsInternal candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification. Upon Hire (Required)External candidates: Certification as a Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SoCRA) or equivalent research certification within one year of hire. 1 Year (Required)Functional AccountabilitiesResponsible Conduct of ResearchConsistently demonstrates adherence to the standards for the responsible conduct of research.Plans, conducts and manages research projects within federal and institutional regulations and policies under the direction of the principal investigator.Stays informed of and adheres to institutional policies, and federal regulations (e.g. Titles 21 and 45 of the Code of Federal Regulations) and guidances (International Counsel on Harmonization) regarding human subjects’ research and use of protected health information.Uses research funds and resources appropriately.Maintains confidentiality of data as required.Meets all annual job-related training and compliance requirements.Research AdministrationMaintains knowledge and comprehension of assigned research protocols, including study procedures, timelines and eligibility.Accurately creates, completes, maintains, organizes and accounts for study materials, including participant lists and visit logs, regulatory binders, case report forms, laboratory kits, investigational product(s) and participation incentives.Uses and accounts for research funds and resources at performance level, including reconciling research subject billing if assigned.Attends study meetings, which could include overnight travel, as requested by principal investigator.Works well with other members of the research team, appreciates a diverse workplace and seeks and provides input when appropriate.Serves as an effective liaison between the investigators, sponsors, hospital departments involved with research studies and the Clinical Research Center.Identifies and resolves issues and challenges with appropriate input and oversight.Reviews journals, abstracts and scientific literature to obtain information relevant to clinical research programs.Creates standard operating procedures (SOPs), and implements operational plans.Provides oversight and training to study team members for a variety of studies.Develops study documents, including consent forms and protocols.Adheres to the IRB-approved recruitment plan.Screens subjects for eligibility per the protocol and institutional municates effectively and provides information to a diverse, vulnerable subject population in accordance with institutional teracts with study participants and/or legally authorized representatives (LARs) to communicate study purpose and participation details and to assess participation interest.Engages participants/LARs in the informed consent process according to institutional policies.Study ManagementConducts/participates in feasibility assessments to ensure adequate site resources and infrastructure are available for protocol participation.Plans, conducts and manages research activities in accordance with federal regulations and guidance documents and sponsor and institutional policies under the direction of a senior study team member.Ensures regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB and other oversight bodies in accordance with federal regulations, sponsor SOPs and institutional policies.Authors study submissions and related documents based on functional role; this may include IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications and scholarly presentations and publications.Registers and records participant visits in the appropriate tracking system.Anticipates study needs and subject caseload to meet organizational objectives and deadlines in a timely manner.Coordinates, prepares for and responds to routine oversight body visits and dependently authors reports to oversight bodies and/or trains and oversees staff performing these tasks.Data CollectionEnsures data is collected as required by protocol and in accordance with research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate and Complete).Ensures that queries are resolved within sponsor and institutional timelines.Plans and performs research specimen collection, labeling and storage/shipping if assigned; maintains accurate sample accountability/chain of custody documentation.Ensures secure storage of study documents.Anticipate and responds to customer needs; follows up until needs are metTeamwork/CommunicationDemonstrate collaborative and respectful behaviorPartner with all team members to achieve goalsReceptive to others’ ideas and opinionsPerformance Improvement/Problem-solvingContribute to a positive work environmentDemonstrate flexibility and willingness to changeIdentify opportunities to improve clinical and administrative processesMake appropriate decisions, using sound judgmentUse resources efficientlySearch for less costly ways of doing thingsSafetySpeak up when team members appear to exhibit unsafe behavior or performanceContinuously validate and verify information needed for decision making or documentationStop in the face of uncertainty and takes time to resolve the situationDemonstrate accurate, clear and timely verbal and written communicationActively promote safety for patients, families, visitors and co-workersAttend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performancePrimary LocationDistrict of Columbia-WashingtonWork LocationsCN Hospital (Main Campus) 111 Michigan Avenue NW Washington 20010JobResearchOrganizationCtr Clinical & Community RsrchPosition Status : R (Regular) - FT - Full-TimeShift : DayWork Schedule : 0830-1700Job PostingSep 8, 2025, 2:17:48 PMFull-Time Salary Range54516.8 - 90854.4Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law. The “Know Your Rights” poster is available here: and the pay transparency policy is available here:Know Your Rights Pay Transparency Nondiscrimination Poster.Please note that it is the policy of Children's National Hospital to ensure a “drug-free” work environment: a workplace free from the illegal use, possession or distribution of controlled substances (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees and contractors). Though recreational and medical marijuana are now legal in the District of Columbia, Children's National and its affiliates maintain the right, in accordance with our policy, to enforce a drug-free workplace, including prohibiting recreational or prescribed marijuana. #J-18808-Ljbffr

Created: 2025-10-06