- Assist in leading investigators through the navigation process to develop investigator-initiated protocols.
- Contribute or develop protocols, consent forms, and other regulatory documents while assessing protocol feasibility and teaching investigators how to formulate electronic IRB submissions.
- Help create tools, processes, and training to enhance the administration and execution of studies.
- Teach and guide trainees and research teams on how to conduct/implement research studies while incorporating ICH/GCP principles, including organizing initiation meetings, source documentation development, internal monitoring, adverse event reporting, and conducting participants visits.
- Advise research teams about assessing adverse events, deviations, protocol compliance, new regulations, etc., and demonstrate actions to minimize risk.
- Identify tools to capture data in accordance with ALCOA-C principles.
- Providing written orders of the participant's study visit to the nursing staff.
- Conduct the study visit(s) as the LIP, and follow up with abnormal assessments and lab results.
- Notify the IRB about serious or unanticipated adverse events and protocol deviations.
- Bachelor's degree required.
- CCRC certification is highly preferred.
- Master's degree in nursing and Board-Certified Adult or Family NP preferred; educational emphasis in clinical research, science, or nursing is preferred.
- A minimum of four years of Clinical Research Coordinator experience, including research in investigator-initiated research and IND/IDE trials.
- Advanced leadership skills and knowledge in the complete lifecycle of protocol development, including implementation of study-related activities.
- Knowledge of Good Clinical Practice (GCP) and FDA Guidelines and high proficiency with Microsoft Office (Word, Excel, Databases, and spreadsheets) necessary. Working knowledge of REDcap is a plus.
- Exceptional critical thinking and creative problem-solving skills.
- Excellent verbal and written communication skills.
- Motivated to grow through seeking professional development opportunities.
- Excellent organizational skills with demonstrated ability to prioritize assignments, maintain workflow, and work productively in meeting critical deadlines.
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Clinical Research Coordinator - New York, United States - Rockefeller University
Description
Organization Overview:
The Institute for Global Infectious Disease Research at The Rockefeller University seeks to empower a revolution in biomedicine and accelerate the pace at which the world conquers infectious diseases.
Overview:
The Rockefeller University, the world's premier Research University, seeks a Clinical Research Coordinator to join our Hospital.
Responsibilities:If the Clinical Research Coordinator is a Nurse Practitioner, additional responsibilities may include the following:
Rockefeller University does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy, gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service or other non-merit factor. All qualified applicants will receive consideration for employment without regard to the characteristics listed above.
The salary of the finalist selected for this role will be set based on various factors, including but not limited to organizational budgets, qualifications, experience, education, licenses, specialty, and training. The hiring range provided represents The Rockefeller University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Compensation Range: Min:USD $90,000.00/Yr.
Compensation Range: Max:
USD $130,000.00/Yr.