Associate Clinical Research Regulatory Coord

Ochsner Health•New Orleans, LA

1d•Onsite

About The Position

This job 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 research management and the Principal Investigator and under the supervision of a senior team member. 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.
1 year of relevant research experience in a clinical setting, OR a bachelor's degree in life science or related field.
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.
Proficiency in using computers, software, and web-based applications including working Knowledge of Epic.

Responsibilities

Manages research activities associated with clinical trials and data management under the supervision of a senior staff member and facilitates successful study start-up.
Maintains study compliance, ensures compliance with regulatory guidelines, and submits protocols and amendments to IRB on behalf of sponsors.
Participates in internal and external audits.
Prepares and organizes essential documents.
Completes status reporting and enters data.
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.