Sr. Clinical Research Coordinator

Children's National Hospital

2d • $54,683 - $91,146

About The Position

The Senior Clinical Research Coordinator independently leads the day-to-day operations of clinical research studies conducted by a principal investigator, with limited supervision. The role also performs complex work involving the collection, compilation, documentation, and analysis of clinical research data. The coordinator develops functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations. The position may support multiple investigators on clinical and translational research projects and direct the work of Clinical Research Assistants and Clinical Research Coordinators as assigned.

The role manages research projects in accordance with applicable regulations, guidance, and institutional and sponsor policies. Responsibilities include maintaining study documentation and regulatory integrity, supporting participant recruitment and informed consent, coordinating study visits and data collection, preparing submissions and reports, and providing oversight and training to study team members. The coordinator may also participate in study meetings that involve overnight travel.

Requirements

• Bachelor’s degree in a science, technical, health-related field, or other applicable discipline and at least 3 years of relevant experience; or a master’s degree and at least 2 years of relevant experience.
• Knowledge of clinical research designs and the infrastructure needed to support them.
• Familiarity with databases, data collection tools, and data analysis methods.
• Ability to manage multiple complex activities with close attention to detail while maintaining awareness of the organizational mission.
• Interpersonal skills demonstrating formal and informal leadership in a diverse professional environment.
• Internal candidates must hold CCRP certification through SoCRA or equivalent research certification upon hire.
• External candidates must obtain CCRP certification through SoCRA or equivalent research certification within one year of hire.

Responsibilities

• Plan, conduct, and manage research projects in accordance with federal and institutional regulations and policies under the direction of the principal investigator.
• Follow responsible conduct of research standards, protect confidential data, use research resources appropriately, and complete annual job-related training and compliance requirements.
• Maintain knowledge of assigned protocols, study procedures, timelines, and eligibility criteria.
• Create, complete, maintain, organize, and account for study materials, including participant lists, visit logs, regulatory binders, case report forms, laboratory kits, investigational products, and participation incentives.
• Use and account for research funds and resources, including reconciling research subject billing if assigned.
• Attend study meetings as requested by the principal investigator; meetings may involve overnight travel.
• Serve as a liaison among investigators, sponsors, hospital departments involved in research, and the Clinical Research Center.
• Identify and resolve issues and challenges with appropriate input and oversight.
• Review journals, abstracts, and scientific literature relevant to clinical research programs.
• Create standard operating procedures and implement operational plans.
• Provide oversight and training to study team members and direct the work of Clinical Research Assistants and Clinical Research Coordinators as assigned.
• Develop study documents, including consent forms and protocols.
• Follow IRB-approved recruitment plans; screen subjects for eligibility in accordance with protocols and institutional policies.
• Communicate study information to diverse and vulnerable populations, interact with participants and legally authorized representatives, and conduct informed consent in accordance with institutional policies.
• Participate in feasibility assessments to ensure adequate site resources and infrastructure for study protocols.
• Prepare and submit accurate, timely protocol documents and reports to sponsors, the IRB, and other oversight bodies.
• Author study submissions and related documents, which may include IRB contingency responses, ClinicalTrials.gov postings, Certificate of Confidentiality applications, and scholarly presentations and publications.
• Register and record participant visits in the appropriate tracking system and anticipate study needs and participant caseloads to meet objectives and deadlines.
• Coordinate, prepare for, and respond to routine oversight-body visits and audits.
• Author reports to oversight bodies and/or train and oversee staff performing those tasks.
• Ensure data is collected according to protocol and research data principles (ALCOAC: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete), and resolve queries within sponsor and institutional timelines.
• Plan and perform research specimen collection, labeling, storage, and shipping if assigned; maintain sample accountability and chain-of-custody documentation.
• Ensure secure storage of study documents.

Benefits

• Comprehensive health coverage, including medical, prescription, infertility, and transgender health services.
• Paid time off, including vacation accrual from day one, sick leave, holidays, and a personal day.
• 401(k) plan.
• Healthcare and dependent care spending accounts.
• Employer-paid life, AD&D, and long-term disability coverage, with optional supplemental plans.
• Tuition assistance.
• Fitness resources.
• Employee assistance.
• Commuter benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior