Clinical Research Regulatory Coordinator

Ochsner Health; Louisiana; On-site; USD 90,000 - 120,000; Full time

Job summary

Ochsner Health is seeking a Clinical Trials Coordinator to independently manage and coordinate all aspects of clinical trials in collaboration with research management and Principal Investigators. You will ensure regulatory compliance, manage data, and oversee study start-up while maintaining strong sponsor relations.

The role requires 3 years of clinical research experience or 2 years with ACRP/SOCRA certification, and a solid knowledge of research terminology and Epic.

Qualifications

• 3 years of relevant research experience in a clinical setting.
• OR 2 years of relevant research experience with Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) certification.
• Strong knowledge of medical and clinical research terminology.

Responsibilities

• Manages research activities associated with clinical trials and data management and facilitates successful study start-up.
• Maintains study compliance, ensures compliance with regulatory guidelines, and participates in internal and external audits.
• Manages data and leads special projects and tracks projects.
• Maintains strong relations with study sponsors.
• Seeks opportunities for individual and departmental continuing education.
• Performs other related duties as assigned.

Skills

Critical thinking

Clinical research terminology

Regulatory knowledge

Grant budgeting

Epic

Verbal and written communication

Organizational skills

Time management

Attention to detail

Teamwork

Education

High school diploma or equivalent

Tools

Epic

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 independently manages and coordinates all aspects of the clinical trials for selected departments and populations according to regulatory and institutional guidelines and requirements in collaboration with the research management and the Principal Investigator. Coordinates and conducts the implementation of all research trials to comply with federal and institutional requirements.

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 Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) certification.

Knowledge, Skills and Abilities (KSAs)

• Strong critical thinking skills and strong knowledge of medical and clinical research terminology and processes.
• Knowledge of safe protocol management in clinical trials.
• Ability to coordinate and oversee the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
• Knowledge of grant and budget development.
• 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.
• Strong organizational, time management and prioritization skills and ability multi-task, pay close attention to detail, and learn and apply new techniques.
• Ability to promote teamwork and support departmental, division and institutional goals.
• Ability to travel throughout and between facilities and work a flexible work schedule (e.g. 24/7, weekends, etc.).

Job Duties

• Manages research activities associated with clinical trials and data management and facilitates successful study start-up.
• Maintains study compliance, ensures compliance with regulatory guidelines, and participates in internal and external audits
• Manages data and leads special projects and tracks projects.
• Maintains strong relations with study sponsors.
• Seeks opportunities for individual and departmental continuing education.
• 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.

Sedentary Work - Exerting up to 10 pounds of force occasionally (Occasionally: activity or condition exists up to 1/3 of the time) and/or a negligible amount of force frequently (Frequently: activity or condition exists from 1/3 to 2/3 of the time) to lift, carry, push, pull, or otherwise move objects. Sedentary work involves sitting most of the time but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

Normal routine involves no exposure to blood, body fluid or tissue and as part of their employment, incumbents are not called upon to perform or assist in emergency care or first aid.

The incumbent has no occupational risk for exposure to 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.

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, Maine, 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 [e-mail]. 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.