Associate Clinical Research Coordinator - Research - Full Time

Ochsner Clinic Foundation•New Orleans, LA

About The Position

Evaluates, initiates, and maintains clinical trial activities with guidance from departmental staff. Communicates with funding agencies, sponsors, other departments, staff, and patients to ensure that clinical-trial requirements are understood. Organizes and manages patient-care requirements for research studies under the direction and approval of other research staff. The role supports participant recruitment and screening, coordinates study visits and patient activity, arranges protocol-required tests and procedures, performs clinical laboratory activities as required, and maintains study documentation and data. Work must follow Good Clinical Practice guidelines and applicable laws, regulations, accreditation standards, and regulatory requirements. The position involves work in patient-care areas and routine potential exposure to blood, body fluids, tissue, communicable diseases, hazardous medications, and hazardous waste. The listed responsibilities are not exhaustive and may change.

Requirements

  • High school diploma or equivalent.
  • One year of relevant research or clinical experience, or a bachelor's degree in life science or a related field.
  • Current American Heart Association Basic Life Support (BLS) certification within 60 days of hire; exceptions apply to employees in fully remote status.
  • Knowledge of medical and clinical research terminology and processes.
  • Familiarity with ICH guidelines for the ethical conduct of research.
  • Ability to follow the investigational plan when conducting study visits.
  • Knowledge of requirements and regulations associated with clinical trials and related research activities.
  • Proficiency with computers, software, and web-based applications, including working knowledge of Epic.
  • Effective verbal and written communication skills.
  • Strong organizational and time-management skills, ability to multitask, and attention to detail.
  • Ability to travel throughout and between facilities and work a flexible schedule.
  • Ability to meet the physical demands of medium work, including exerting 20 to 50 pounds of force occasionally, 10 to 25 pounds frequently, and up to 10 pounds constantly.
  • Ability to work in a patient-care environment with routine duties involving potential exposure to blood, body fluids, tissue, communicable diseases, hazardous medications, or hazardous waste.

Responsibilities

  • Assist with recruiting and screening study participants for eligibility by telephone, in clinics, and in other settings as required.
  • Coordinate and oversee participant activity related to research and clinical trials, including informed consent under the direction and supervision of more senior research staff.
  • Arrange protocol-required tests and procedures and report results to the investigator.
  • Perform clinical laboratory activities as required by study protocols.
  • Develop and maintain required documentation for assigned clinical trials and associated patient care.
  • Enter data into sponsor-specific systems and/or support the data coordinator, including resolving queries.
  • Conduct daily work and clinical-trial activities in accordance with Good Clinical Practice guidelines.
  • Adapt communication and conduct to the needs of the patient population, including respecting privacy, introducing oneself appropriately, explaining services or procedures, requesting permissions, and adapting communication style.
  • Remain knowledgeable about applicable laws, regulations, accreditation standards, and regulatory requirements, and ensure compliance.
  • Report known or suspected unethical or questionable conduct and patient, employee safety, privacy, or other compliance concerns immediately.
  • Perform other related duties as assigned.
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