Clinical Research Coordinator - Multispecialty Surgery

Ochsner Health•New Orleans, LA

2d•Onsite

About The Position

This job evaluates, initiates and maintains activities related to the conduct of clinical trials with the assistance and guidance of departmental staff. Communicates effectively with external funding agencies and sponsors, other departments, departmental staff and patients to assure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, research division/ Occupational Health and Safety (OHS) policy and patient care requirements of the company with the direction and approval of other research staff.

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 ACRP or SOCRA certification.
Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status.
Knowledge of medical and clinical research terminology and processes.
Working knowledge of ICH guidelines for ethical conduct of research.
Strong critical thinking skills.
Ability to follow and provide critical feedback on the investigational plan
Ability to develop study related budgets, contracts, and patient consent documents.
Working knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity.
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 throughout the patient care process.
Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and learn new techniques.
Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts.

Responsibilities

Organizes strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required.
Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI).
Serves as primary point of contact for patient to report and triage adverse events and independently conducts informed consent.
Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment.
Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies.
Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems.
Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
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.