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This job evaluates, initiates, and maintains all activities related to the conduct of clinical trials. 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. Independently organizes and manages all patient care requirements of the company. Serves as an escalation point for junior level departmental staff for problem resolution and support, and coordinates trials that are the most complex and/or the greatest number of trials.
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 - 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.
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.
- 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.
Job Duties
- Evaluates competing strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings and 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 serves as a mentor to staff on obtaining 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.
- Provides 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.
- 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 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 [email protected]. 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.
