Clinical Research Regulatory Coordinator - Oncology

Ochsner Health • New Orleans, LA

3d • Onsite

About The Position

This job independently manages and coordinates all aspects of the clinical trials for selected departments and populations according to regulatory and institutional guidelines and requirements in collaboration with the research management and the Principal Investigator. Coordinates and conducts the implementation of all research trials to comply with federal and institutional requirements.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

Requirements

• High school diploma or equivalent.
• 3 years of relevant research experience in a clinical setting,
• OR 2 years of relevant research experience in a clinical setting with Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) certification.
• Strong critical thinking skills and strong knowledge of medical and clinical research terminology and processes.
• Knowledge of safe protocol management in clinical trials.
• Ability to coordinate and oversee the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
• Knowledge of grant and budget development.
• Proficiency in using computers, software, and web-based applications including working knowledge of Epic.
• Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals.
• Strong organizational, time management and prioritization skills and ability multi-task, pay close attention to detail, and learn and apply new techniques.
• Ability to promote teamwork and support departmental, division and institutional goals.
• Ability to travel throughout and between facilities and work a flexible work schedule (e.g. 24/7, weekends, etc.).

Responsibilities

• Manages research activities associated with clinical trials and data management and facilitates successful study start-up.
• Maintains study compliance, ensures compliance with regulatory guidelines, and participates in internal and external audits
• Manages data and leads special projects and tracks projects.
• Maintains strong relations with study sponsors.
• Seeks opportunities for individual and departmental continuing education.
• Performs other related duties as assigned.
• Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED