Summary

The Senior Research Coordinator independently coordinates and manages complex clinical research studies in accordance with federal regulations, sponsor requirements, institutional policies, and Good Clinical Practice (GCP) guidelines. The position is responsible for the day-to-day operational management of clinical trials, including participant recruitment, study conduct, regulatory compliance, data quality, sponsor interactions, and study closeout activities for the division of Pediatric Neurology. The Senior Research Coordinator exercises substantial professional judgment and operates with minimal supervision while supporting investigators, study teams, and departmental research initiatives.

Provides independent clinical and administrative management of multiple complex therapeutic/interventional drug clinical research studies. Position requires leading rapid study start-up, high participant volumes, and intricate protocol requirements. Participates in study qualification and feasibility assessments and provides operational recommendations to Principal Investigators and Research Managers. Serves as a resource and mentor to research personnel while ensuring compliance with protocol requirements, regulatory standards, and institutional policies.

Job Duties

Subject Visits – 30%

• Provides study-specific education to research participants within scope of practice.
• Reviews study protocols with participants and verifies informed consent documentation prior to study activities.
• Schedules participants for protocol-required tests and procedures, including laboratory assessments and study-specific evaluations.
• Dispenses investigational products in accordance with protocol requirements, institutional policies, and applicable regulatory standards while maintaining complete drug accountability records.
• Collects, processes, stores, and ships biological specimens in accordance with protocol requirements, laboratory manuals, and IATA guidelines.
• Monitors participants throughout study participation and ensures participant safety, rights, and welfare are maintained. 
• Identifies, documents, and facilitates reporting of adverse events, serious adverse events, and protocol deviations in accordance with protocol requirements and regulatory timelines.

Screening & Enrollment – 20% 

• Screens, recruits, and enrolls patients/participants into complex clinical research studies in accordance with approved protocols.
• Conducts participant interviews and verifies eligibility based on comprehensive inclusion and exclusion criteria. 
• Educates participants on study purpose, procedures, risks, and requirements and conducts the informed consent process in compliance with GCP and institutional policies.
• Exercises independent judgment in evaluating participant eligibility and protocol compliance. 
• Supports study feasibility assessments through evaluation of patient populations, protocol requirements, staffing resources, and operational workflows. 

Data Collection & Entry – 20%

• Collects, documents, and records study-related data in collaboration with Principal Investigators, physicians, advanced practice providers, research nurses, and data managers. 
• Obtains participant information through direct interviews, questionnaires, and medical record abstraction; enters data into case report forms and electronic data capture systems.
• Maintains accurate source documentation, study records, and essential study files to ensure compliance with regulatory requirements.
• Ensures the accuracy, completeness, and scientific integrity of study data through ongoing review and quality oversight. 
• Assists with study monitoring visits, audits, and inspections as required. 

Additional Duties

Source Document Development & Review – 15%

• Prepares and maintains documentation required for initial and continuing regulatory approval of assigned research protocols.
• Oversees the development, organization, quality review, and maintenance of study source documents and regulatory files. 
• Ensures study documentation meets sponsor, institutional, FDA, and GCP requirements.
• Participates in study start-up activities, including review of protocol requirements, operational workflows, and site readiness.
• Provides guidance to research staff regarding study documentation standards and protocol implementation. 

Communication with Sponsors, Subjects, and Investigators – 15%

• Communicates independently with Principal Investigators, sponsors, contract research organizations (CROs), and study teams regarding study conduct, enrollment status, and operational challenges.
• Submits serious adverse event reports, protocol deviations, and follow-up documentation within required timelines.
• Facilitates study-related communication across participating sites, departments, and external partners.
• Coordinates study-related supplies, investigational products, equipment, and vendor activities as needed.
• Trains and mentors clinical research personnel on study operations, enrollment processes, protocol requirements, EMR workflows, regulatory requirements, and SOP compliance.
• Provides oversight and operational guidance to lower-level research personnel regarding study set-up, conduct, and research best practices.
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications and Skills

• Bachelor’s degree in scientific, healthcare, or public health related fields.
• Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC).
• Therapeutic clinical research study experience.
• Extensive knowledge of FDA regulations, OHRP requirements, ICH-GCP guidelines, and human subject protections. 
• Able to work in a fast-paced environment, comfortable working in a team environment, and leading the various stages of complex clinical research studies (feasibility, startup, enrollment, closeout).
• Excellent organization skills, able to multitask, and strong verbal, written, and interpersonal skills.