Associate Clinical Research Coordinator

ochsner; New Orleans (LA); On-site; USD 42,000 - 65,000; Full time

Job summary

Ochsner in New Orleans seeks a Clinical Research Associate to evaluate, initiate, and maintain activities related to the conduct of clinical trials under supervision. You will communicate with sponsors, organize patient care, and ensure adherence to protocol requirements and Good Clinical Practice guidelines.

Requirements include a high school diploma or equivalent (or a life science degree), 1 year of relevant experience or a life sciences degree, and BLS certification within 60 days of hire.

Qualifications

• Knowledge of medical and clinical research terminology and processes.
• Familiarity with ICH guidelines for ethical conduct of research.
• Ability to follow the investigational plan in execution of study visits.
• Strong organizational and time management skills and ability to multi-task and pay close attention to detail.
• 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.
• Organizational and time management skills and ability pay close attention to detail.
• Ability to travel throughout and between facilities and work a flexible work schedule.

Responsibilities

• Assists in 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 including informed consent under direction and supervision of more senior research staff.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Performs clinical laboratory activities as required per protocol.
• 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.
• 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.

Skills

Clinical research terminology

ICH guidelines knowledge

Investigational plan execution

Excellent organizational skills

Regulatory compliance knowledge

Proficiency with computers and Epic

Effective written and verbal коммуника

Travel flexibility

Education

High school diploma or equivalent

Bachelor's degree in life science or related field

Tools

Epic

MS Office

Job description

Exceptional care starts with exceptional people.

For us, this is more than a job- it's a calling. It's waking up each day, looking for ways to make a difference with a compassionate, inclusive and talented team. Ochsner empowers you to discover your passion, reach your potential, and Pursue Your Purpose. Exceptional care starts with exceptional people and teams. Together we are leading the way.

This job evaluates, initiates, and maintains activities related to the conduct of clinical trials with the assistance and guidance of departmental staff. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements of the company with the direction and approval of other research staff. 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.

Education

Required - High school diploma or equivalent.

Work Experience

Required - 1 year of relevant research or clinical experience,

OR

Bachelor's degree in life science or related field.

Certifications

Required - 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 Skills and Abilities (KSAs)

• Knowledge of medical and clinical research terminology and processes.
• Familiarity with ICH guidelines for ethical conduct of research.
• Ability to follow the investigational plan in execution of study visits.
• Strong organizational and time management skills and ability to multi-task and pay close attention to detail.
• 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.
• Organizational and time management skills and ability pay close attention to detail.
• Ability to travel throughout and between facilities and work a flexible work schedule.

Job Duties

• Assists in 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 including informed consent under direction and supervision of more senior research staff.
• Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
• Performs clinical laboratory activities as required per protocol.
• 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.
• 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.

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

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.

This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.

The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Physical and Environmental Demands

The physical demands describe