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Senior Clinical Research Coordinator - Women's Services - Baptist

Manage regulatory submissions and documentation for multiple clinical trials
New Orleans, Louisiana, United States
Senior
2 days ago
Ochsner Health

Ochsner Health

A Louisiana-based non-profit healthcare provider offering a wide range of medical services, including hospitals and clinics.

15 Similar Jobs at Ochsner Health

Clinical Research Coordinator

We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.

At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!

This job evaluates initiates and maintains activities related to the conduct of clinical trials in multiple assigned areas of responsibility. 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. Independently organizes and manages all documentation and regulatory submissions as required by the sponsor of the trial, regulatory agencies, Research division/OHS policy and patient care requirements of Ochsner. Functions as project manager for clinical trials in assigned areas of responsibility and serves as an escalation point for junior level departmental staff for problem resolution and support.

Education

Required - High School diploma or equivalent

Preferred - Bachelor's degree in Science or related field; Master's degree in Public Health or related field

Work Experience

Required - 9 years relevant research experience; or 6 years of research experience in a clinical setting with a Bachelor of Science degree

Preferred - Experience in area of assigned clinical specialty Experience in clinical research Experience with data entry and data base management

Certifications

Current Basic Life Support (BLS) certification from the American Heart Association

Knowledge Skills and Abilities (KSAs)

  • Must have computer skills and dexterity required for data entry and retrieval of required job information.
  • Must be proficient with Windows-style applications and keyboard, and various software packages specific to role.
  • Effective verbal and written communication skills and the ability to present information clearly and professionally to varying levels of individuals throughout the required job processes.
  • Strong interpersonal skills.
  • Critical thinking skills to apply to the process of trial evaluation and submission, particularly the development of study related budgets, contracts and patient consent documents.
  • Ability to effectively work independently.
  • Strong organizational and prioritization skills.
  • Working knowledge and experience in clinical research.
  • Ability and willingness to learn and apply new techniques.
  • Reliable transportation to travel across the system.
  • Ability to work flexible hours, when applicable.

Job Duties

  • Coordinates and oversees the regulatory processes as they relate to the evaluation, initiation, maintenance, closure and internal and external audit of clinical trials and other research activity.
  • Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials.
  • Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care.
  • Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
  • Maintains competency in requirements and regulations associated with the conduct of clinical trials and other related research activity.
  • Supports department, divisions and institutional goals.
  • Provides mentorship, professional development and support to other Clinical Research Coordinators.
  • Other related duties as required.

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. Ochsner 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.

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. Mechanical lifting devices (carts, dollies, etc.) or team lifts should be utilized. Must be able to sit for prolonged periods of time. Must be able to travel throughout and between facilities. Must be able to work a flexible work schedule. 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 diseases. There may be an occupational risk for exposure to all communicable diseases.

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.

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Senior Clinical Research Coordinator - Women's Services - Baptist
New Orleans, Louisiana, United States
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About Ochsner Health
A Louisiana-based non-profit healthcare provider offering a wide range of medical services, including hospitals and clinics.