Research Coordinator - Clinical Trials - Mineola

NYU Langone Health•Mineola, NY

About The Position

NYU Langone Hospital—Long Island is a 591-bed university-affiliated medical center providing diagnostic and therapeutic care across medical and surgical specialties, along with inpatient and outpatient services, medical education, and research. The hospital emphasizes equity and inclusion and supports staff through comprehensive benefits and wellness resources. The Research Coordinator assists the Clinical Manager with research activities in designated departments, including pharmaceutical-sponsored and investigator-initiated projects. The role supports regulatory and clinical aspects of pediatric clinical trials, working with clinical managers, study coordinators, patients, families, and multidisciplinary teams to conduct research safely and in compliance with applicable requirements.

Requirements

  • Bachelor's degree in a related field.
  • CITI certification, or completion within one month of employment.
  • One to two years of experience in a related area, such as pediatrics or perinatal care.
  • Advanced knowledge of Microsoft Office, including Excel and PowerPoint.
  • Database management and informatics skills.
  • Effective communication with all levels of the organization.
  • Ability to work with a variety of people at all levels.
  • Dependability, self-direction, and willingness to take direction and initiative.
  • Ability to manage multiple tasks efficiently and accurately while adhering strictly to task requirements.

Nice To Haves

  • Certification in Clinical Research Coordination.
  • One to two years of experience in a research environment.
  • Excellent written and verbal communication skills.
  • Strong organizational skills and attention to detail.

Responsibilities

  • Promote educational opportunities inside and outside the institution to increase public awareness of the pediatric clinical research program.
  • Assist with staff in-services before new research trials begin and when trial updates occur.
  • Comply with hospital and departmental safety policies, procedures, and regulatory requirements from The Joint Commission, IRB, FDA, and study sponsors.
  • Maintain required certifications, including CITI and Good Clinical Practice (GCP).
  • Support study start-up activities, pre-site visits, subject recruitment and retention, informed consent, and the gathering, recording, and analysis of data.
  • Assist with documents for investigational study selection and project negotiation, including initial site and sponsor correspondence.
  • Assist with clinical-trial regulatory documentation, including IRB communications and submissions, protocol and consent/assent approvals, addendums, amendments or modifications, adverse events, and annual study updates.
  • Assist with patient screening, recruitment, consent, and enrollment for ongoing clinical research projects, including follow-up management visits and case report form completion.
  • Under guidance, assist with source or CRF document completion or electronic data capture (EDC) entry.
  • Interact with study patients during visits and by telephone, and correspond with patients in writing, including letters, emails, and text messages.
  • Support compliance with GCP, ICH, FDA, and IRB regulations and guidelines.
  • Collaborate with the Clinical Manager and a multidisciplinary team to conduct pediatric clinical research safely and enhance education for patients, family members, and significant others.
  • Perform other duties as assigned.

Benefits

  • Comprehensive benefits and wellness package.
  • Financial security benefits.
  • Generous time-off program.
  • Employee resource groups for peer support.
  • Holistic employee wellness program covering physical, mental, nutritional, sleep, social, financial, and preventive-care well-being.
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