Clinical Research Regulatory Coordinator (Open)
Company: Ochsner Clinic Foundation
Location: New Orleans
Posted on: May 24, 2023
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.EducationRequired - High school diploma or
equivalent.Work ExperienceRequired - 4 years of relevant research
experience in a clinical setting,OR2 years of relevant research
experience in a clinical setting with ACRP or 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
- 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
- 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
- Maintains strong relations with study sponsors.
- Seeks opportunities for individual and departmental continuing
- 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 DemandsThe
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.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.
Keywords: Ochsner Clinic Foundation, New Orleans , Clinical Research Regulatory Coordinator (Open), Healthcare , New Orleans, Louisiana
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