Senior Clinical Research Coordinator — IRB & Data Lead

Actalent; New York (NY); Híbrido; USD 48.000 - 58.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Descripción de la vacante

Actalent in Bronx, NY, seeks a Contract to Hire Clinical Research Coordinator to develop study protocols, manage data and assist with grant proposals. You will work with the Principal Investigator to ensure IRB compliance, recruit and supervise interns, and coordinate budget monitoring with the Departmental Administrator.

The role requires 3+ years of CTR experience, strong GCP knowledge, and excellent organizational and communication skills in a deadline-driven environment.

Formación

• Bachelor's degree in a scientific, healthcare, or related field.
• Minimum 3+ years of clinical research coordination experience.
• Experience managing clinical trials independently.
• Strong understanding of GCP, FDA regulations, and IRB processes.
• Experience with patient recruitment, consenting, and study management.
• Excellent organizational, communication, and project management skills.
• Ability to manage multiple priorities in a deadline-driven environment.

Responsabilidades

• Work with PI to develop the study protocol and protocol amendments for the IRB as needed, including the development of new measures.
• Manage data collection, analysis and cleaning, performing regular audits to ensure that the data collected are complete and accurate, and that the research is being conducted as outlined in the protocol.
• Develop appropriate progress reports for the PI, study funding agency and the IRB.
• Assist PI with preparation of grant proposals (new and competing renewals).
• Arrange meetings of study partners, develop meeting agendas, and facilitate meeting.
• Facilitate the preparation of conference abstracts, oral presentations, and poster presentations, and participate in the development of manuscripts for publication.
• Manage the collection of data from importable and exportable formats for rapid dissemination to PIs and sponsors.
• Ensure that adverse events and protocol deviations are submitted to the IRB.
• Represent the study at internal and external academic meetings and community events. Act as a liaison to project partners to discuss new procedures that could be implemented.
• Determine staffing needs to ensure efficient and appropriate coverage, and recommend appropriate changes to staffing patterns as needed. Manage staff performance and valuate the quality of work providing timely and corrective feedback as needed.
• Recruit, acclimate, and supervise undergraduate and graduate student research interns.
• Work with Departmental Administrator to develop and monitor project budgets.

Conocimientos

GCP knowledge

IRB processes

Data management

Project management

Communication skills

Multitasking

Educación

Bachelor's degree in science/healthcare

Descripción del empleo

Actalent in Bronx, NY, seeks a Contract to Hire Clinical Research Coordinator to develop study protocols, manage data and assist with grant proposals. You will work with the Principal Investigator to ensure IRB compliance, recruit and supervise interns, and coordinate budget monitoring with the Departmental Administrator.

The role requires 3+ years of CTR experience, strong GCP knowledge, and excellent organizational and communication skills in a deadline-driven environment.