Associate Clinical Research Coordinator - Research - Full Time

Ochsner Health•New Orleans, LA

About The Position

This role evaluates, initiates, and maintains clinical trial activities with assistance and guidance from departmental staff. The coordinator communicates with external funding agencies and sponsors, other departments, staff, and patients to clarify requirements for conducting and participating in clinical trials. The role also organizes and manages patient-care requirements related to research under the direction and approval of other research staff. The position supports participant recruitment and screening, coordinates research-related patient activities and study visits, arranges protocol-required tests and procedures, performs clinical laboratory activities when required, and maintains trial and patient-care documentation. It includes entering study data and helping resolve data queries, while conducting work in accordance with Good Clinical Practice and applicable laws, regulations, accreditation standards, and agency requirements. The position requires travel throughout and between facilities and a flexible work schedule. It is performed in a patient-care environment and involves routine exposure to blood, body fluids, tissue, specimens that may contain communicable diseases, and possible occupational exposure to hazardous medications or waste. The physical demand classification is Medium Work.

Requirements

High school diploma or equivalent.
One year of relevant research or clinical experience, or a bachelor's degree in life science or a related field.
Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire; exceptions are granted for employees in fully remote status.
Knowledge of medical and clinical research terminology and processes.
Familiarity with ICH guidelines for ethical conduct of research.
Ability to follow the investigational plan when carrying out study visits.
Strong organizational and time-management skills, ability to multitask, and close attention to detail.
Knowledge of requirements and regulations associated with clinical trials and related research activity.
Proficiency with computers, software, and web-based applications, including working knowledge of Epic.
Effective verbal and written communication skills.
Ability to travel throughout and between facilities and work a flexible schedule.

Responsibilities

Assist with recruiting study participants and screening them for eligibility by telephone, in clinics, and in other settings as required.
Coordinate and oversee participant activity related to research and clinical trials, including informed consent under the direction and supervision of more senior research staff.
Arrange protocol-required tests and procedures and report results to the investigator.
Perform clinical laboratory activities as required by the protocol.
Develop and maintain documentation required for assigned clinical trials and associated patient care.
Enter data into sponsor-specific systems and/or support the data coordinator, including resolving queries.
Conduct daily work and trial activity in accordance with Good Clinical Practice Guidelines.
Adapt behavior and communication to the specific patient population, including respecting privacy, explaining services or procedures appropriately, and requesting permissions.
Remain knowledgeable about applicable laws, regulations, accreditation standards, and regulatory requirements and ensure compliance.
Report known or suspected unethical or questionable conduct, patient or employee safety issues, patient privacy concerns, and other compliance-related concerns.
Perform other related duties as assigned.