Sr. Clinical Research Coordinator

Ochsner Health · Baton Rouge, LA · 6 days ago

AnalystFull-time

Evaluations and Initiatives

Evaluates competing strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings. 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).

Responsibilities

Serves as primary point of contact for patient to report and triage adverse events.
Serves as mentor to staff on obtaining informed consent.
Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator.
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.
Mentorship, professional development, and support to less senior team members and interns; assesses quality assurance of study visits and data; periodically reviews and provides constructive feedback on standard operating procedures; and coordinates special projects related to workflow optimization.

Qualifications

Education Required – High school diploma or equivalent.
Work Experience Required - 5 years of relevant research experience in a clinical setting, OR 4 years of relevant research experience in a clinical setting with Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) certification.

Skills and Abilities

Knowledge of medical and clinical research terminology and processes.
Expert understanding of ICH guidelines for ethical conduct of research.
Familiarity with and understanding of lean management principles.
Ability to follow and provide critical feedback on the investigational plan.
Ability to develop study related budgets, contracts, and patient consent documents.
Ability to mentor junior staff members on the requirements and regulations associated with the conduct of clinical trials and other related research activity.
Expertise in using computers and web-based applications including working knowledge of Epic (Super-Users).
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 interpersonal and leadership skills and ability to coach others, as well as effectively work independently.
Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and develop new techniques.
Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts.

Physical and Environmental Demands

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.
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.

Company Information

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. Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website. Please refer to the job description to determine whether the position you are interested in is remote or on-site. Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C. Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at 504-842-4748 (select option 1) or careers@ochsner.org. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. 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.