A prominent pediatric research organization is seeking an experienced Senior Clinical Trials Coordinator to take a lead role in the planning and execution of multiple ongoing and upcoming human subject research studies. This position will support a range of clinical investigations under the oversight of a centralized Clinical Trials Operations team and will play a key role in maintaining regulatory compliance, data quality, and participant safety throughout the research lifecycle.
This is a high-impact position offering the opportunity to work with cutting-edge clinical trials that support children and families, while also mentoring and guiding more junior research personnel.
Key Responsibilities :
- Project Leadership & Oversight
- Serve as the primary coordinator for several complex clinical trials, ensuring protocols are implemented accurately and efficiently.
- Act as a central point of contact between investigators, research staff, regulatory personnel, sponsors, and monitoring organizations.
- Monitor study progress and proactively identify and address operational bottlenecks or compliance risks.
- Participant Management
- Support participant recruitment efforts including eligibility screening, informed consent process, and enrollment procedures.
- Maintain ongoing contact with participants and families, ensuring follow-up activities align with protocol requirements.
- Data & Regulatory Compliance
- Maintain high-quality source documentation and manage accurate, timely data entry into clinical trial management systems (CTMS).
- Prepare and submit regulatory documents, amendments, and continuing review materials in collaboration with internal regulatory affairs teams.
- Ensure data collection adheres to GCP (Good Clinical Practice) and local / institutional policies.
- Mentorship & Team Support
- Provide daily guidance and training to less experienced coordinators and assistants.
- Assist with onboarding new staff and serve as a role model for protocol compliance, professionalism, and patient engagement.
- Reporting & Communication
- Compile and present updates on enrollment figures, site metrics, and project milestones to internal leadership.
- Collaborate with finance, regulatory, and data teams to support audit readiness and funding compliance.
- Attend investigator and operational team meetings to report on study status and address operational needs.
What Were Looking For :
Minimum Qualifications :
Bachelors degree in a scientific or health-related field OR at least 9 years of relevant clinical research experience.A minimum of 5 years of hands-on experience coordinating human subject clinical trials.Eligibility for clinical research certification (e.g., SOCRA or ACRP); must obtain within 12 months of hire.Preferred Skills & Competencies :
Strong understanding of human subject protections, ICH-GCP guidelines, and FDA / IRB regulations.Demonstrated ability to manage multiple trials simultaneously and maintain meticulous documentation.Experience with CTMS platforms and data entry / reporting tools.Proven success in mentoring or supervising others in a clinical research environment.Bilingual (English / Spanish) proficiency is a plus.Familiarity with pediatric clinical research protocols and participant interaction is highly valued.Why Join Us :
Work at the forefront of clinical research in a patient-first environment.Collaborate with multidisciplinary teams on studies that directly impact childrens health and wellness.Be part of a mission-driven organization committed to advancing medical knowledge and access to innovative treatments.Gain exposure to a diverse portfolio of research studies across therapeutic areas.Supportive and collaborative work environment with professional growth opportunities.Work Environment :
On-site engagement is required with flexibility for hybrid scheduling depending on study needs and organizational policy.Interactions with patients, families, investigators, and external research stakeholders are a regular part of this role.Please note : This job posting is just a preview of the full scope of the position. A comprehensive job description is shared by a member of our team.