Clinical Trials Data Specialist

NYU Langone Hospitals; New York (NY); On-site; USD 54,000 - 55,000; Full time

Job summary

NYU Langone Health's Grossman School of Medicine is seeking a Research Data Associate to support clinical trials and research under supervision. The successful candidate will work with School of Medicine and Medical Center staff and departments to ensure data integrity, regulatory compliance, and timely study activities.

The role involves maintaining knowledge of GCP, developing SOPs, completing site qualification questionnaires, conducting pre-study visits, and collaborating with investigators

Qualifications

• Associate's degree plus one year related experience.
• Computer literate with good interpersonal, writing and verbal communication skills.
• Bachelor's degree preferred in science, public health or related field.

Responsibilities

• Maintain knowledge of GCP and ethical conduct for human subjects.
• Aid in development of protocol-specific standard operating procedures.
• Complete site qualification questionnaires and assess the Hassenfeld Children's Center ability to participate.
• Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial.
• Collaborate with investigators to prioritize submission and activation of clinical trials.
• Provide regulatory counsel and guidance to study members.
• Develop and implement local protocols (consent forms, study calendars, LOIs) and single patient INDs.
• Develop trial-specific patient informed consent forms for highly complex trials.
• Prepare, submit and obtain initial approval from mandatory scientific review committees.
• Timely submission of all regulatory documents to ensure activation timelines are met.
• Submission of study amendments and ongoing regulatory updates.
• Obtain continuing approvals from various committees and organizations.
• IND Safety Report reviews, submissions, and reporting.
• Create and maintain regulatory master files for industry and investigator-initiated Oncology Trials.
• Assist the clinical team in developing trial-specific training tools for staff.
• Perform day-to-day activities like obtaining signatures, filing documents, and maintaining study binders/electronic folders.
• Organize Site Initiation Visits with Sponsor/CRO and Clinical Team.
• Maintain audit-ready regulatory files during Monitoring Visits.

Skills

Interpersonal skills

Written communication

Verbal communication

Education

Associate's degree

Bachelor's degree

Job description

NYU Langone Health's Grossman School of Medicine is seeking a Research Data Associate to support clinical trials and research under supervision. The successful candidate will work with School of Medicine and Medical Center staff and departments to ensure data integrity, regulatory compliance, and timely study activities.

The role involves maintaining knowledge of GCP, developing SOPs, completing site qualification questionnaires, conducting pre-study visits, and collaborating with investigators