This role manages the initiation and maintenance of clinical trials, including participant recruitment, screening, and regulatory documentation. The coordinator serves as a liaison between patients and Principal Investigators while ensuring compliance with ethical and safety guidelines.
Requirements summary
Requires a high school diploma and either 3 years of clinical research experience or 2 years with ACRP/SOCRA certification. A current BLS certification from the American Heart Association is required within 60 days of hire.
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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.
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 - 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.
Certifications 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.
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.
Job Duties 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.
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 described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects.
Physical demand requirements are in excess of those for Sedentary Work.
Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible.
NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Duties performed routinely require exposure to blood, body fluid and tissue.
The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases.
The incumbent has an occupational risk for exposure to all communicable diseases.
Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste.
The risk level of exposure may increase depending on the essential job duties of the role.
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Ochsner is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
Ochsner Health is the leading not-for-profit healthcare provider in the Gulf South, delivering expert care at its 46 hospitals and more than 370 health and urgent care centers.
For 12 consecutive years, U.S.
News & World Report has recognized Ochsner as the No.
1 hospital in Louisiana.
Additionally, Ochsner Children’s has been recognized as the No.
1 hospital for kids in Louisiana for three consecutive years.
Ochsner inspires healthier lives and stronger communities through a combination of standard-setting expertise, quality and connection not found anywhere else in the region.
In 2023, Ochsner Health cared for more than 1.5 million people from every state in the nation and 65 countries.
Ochsner’s workforce includes more than 38,000 dedicated team members and over 4,700 employed and affiliated physicians.
To learn more about how Ochsner empowers people to get well and stay well, visit https://www.ochsner.org/. Ochsner Health is proud to be an Employer of Choice.
Ranked one of Newsweek's list of America's Greatest Workplaces for Diversity of 2024 Becker's Healthcare listed Ochsner Health as 150 Top Places to Work in Healthcare Awarded Culture Awards for Purpose and Values and Healthcare Industry by Top Workplace Ranked as a 2023 Top Workplace in the USA!
The Top Workplaces USA award is based entirely on feedback from an employee engagement survey completed by the employees of participating workplaces.
Awarded Top Work Places 2023 for six consecutive years by The Times-Picayune Earned 2022-2023 Great Place to Work Certification™ Ochsner Health named to Newsweek's America's Greatest Workplaces for Parents and Families 2023 Opportunities listed here represent open positions at Ochsner Health and Ochsner Health managed entities.
