Clinical Research Coord I

Columbia University in the City of New York; New York (NY); Vor Ort; USD 61.000 - 75.000; Vollzeit

Zusammenfassung

Columbia University in the City of the City of New York seeks a Clinical Research Coordinator I for the Pediatric Neuro Muscular Division in the Department of Neurology. The candidate should be highly motivated with excellent interpersonal, communication, and writing skills and a strong interest in academic clinical research.

You will work to establish rapport with children, adults and families, and collaborate with clinical, research and administrative teams to ensure trials run smoothly and in

Qualifikationen

• Requires a Bachelor's degree or equivalent in education and experience.
• Experience with neuromuscular clinical trials.
• Must be highly organized with attention to detail.
• Proficient in English (spoken and written).
• Proficient in MS Word, MS Excel, MS PowerPoint; EPIC; Adobe Acrobat.

Aufgaben

• Participation in pre-study, initiation, monitoring and close-out visits.
• Submission of IND forms and PI initiated research protocols to FDA and other regulatory bodies.
• Implementation of clinical trials from initiation, including SOPs and case report forms.
• Recruitment and supervision of trial subjects through consent, screening, and adherence to safety.
• Coordination and management of trials, communication with sponsor/monitors, visit coordination, sample processing.
• Reporting and documentation of protocol deviations, development of corrective action plans.
• Data collection and management, source documents, adverse events, filing and archiving, monitoring visits.
• Data entry and queries using EDC systems.
• Close-out, manuscripts, audit prep, final study report, and financial obligations.
• Perform other related duties as assigned.

Kenntnisse

Interpersonal skills

Communication

Writing skills

Ausbildung

Bachelor's degree

Tools

EPIC

MS Word

MS Excel

MS PowerPoint

Adobe Acrobat

Jobbeschreibung

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule: M-F
• Building:
• Salary Range: 68,000 - 68,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

We are seeking a Clinical Research Coordinator I for the Pediatric Neuro Muscular Division in the Department of Neurology. The candidate must be highly motivated, be interested in pediatric neuromuscular diseases, possess excellent interpersonal, communication, and writing skills as well as strong interest in academic clinical research. The candidate will be expected to establish cordial and professional rapport with children, adults and families as well as the clinical, research, and administrative teams. The ideal candidate is a team player who is also independently motivated and able to self-direct to complete tasks.

Responsibilities

• Participation in pre-study, initiation, monitoring and close-out visits
• Submission of Investigator New Drug (IND) forms and PI initiated research protocols to FDA and other regulatory institutions in US
• Implementation of clinical trials from initiation, including participation in the development of standard operating procedures and case report forms
• Recruitment and supervision of clinical trial subjects through the following activities: informed consent, screening, and ensuring subjects adherence to safety and study compliance issues.
• Coordination and management of clinical trials, communication with sponsor and monitors, study visit coordination, sample acquisition and processing.
• Reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Principal Investigator as needed
• Data collection and management, collection of source documents, registration, and management of adverse events, filing and archiving, managing monitoring visits and managing queries.
• Participate in data entry and query resolution using Electronic Data Capture (EDC) systems
• Close-out of the clinical trial, contributing to manuscripts, audit preparation, trial completion, and communication with authorities. Other responsibilities include assisting with the final study report and completing financial obligations.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Requires a Bachelor's degree or equivalent in education and experience.

Preferred Qualifications

• Experience with neuromuscular clinical trials.

Other Requirements

• Must be highly organized with attention to details.
• Mastery of spoken and written English required.
• Computer skills are required including proficiency of MS Word, MS Excel, MS PowerPoint, EPIC (electronic medical record) and Adobe Acrobat.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.