Parkland Health-posted 4 months ago
Dallas, TX
Hospitals

Responsible for leading the review, approval, facilitation and compliance oversight of clinical and health services research conducted at Parkland Health & Hospital System, in order to ensure that research conducted at Parkland meets regulatory, ethical, operational and institutional requirements and proper utilization of Parkland resources.

  • Lead the development and evaluation of clinical research program policies and procedures to meet Parkland Federal Wide Assurance with Office of Human Research Protection (OHRP), DHHS, FDA and Joint Commission requirements for the conduct of safe and ethical research involving Parkland patients, facilities and/or resources.
  • Organize, review and facilitate the approval of research proposals submitted to the Clinical Research Office, ensuring that research activity meets objectives such as efficient utilization of resources and adherence to policies and procedures.
  • Work as a liaison between research investigator, patient care divisions, and support departments to support the implementation of research activity.
  • Serve as a resource for the department accountant in setting up research accounts and advising the research team about Parkland research charges.
  • Assist with training and mentoring activities, serving as a resource expert for department employees.
  • Review more complex studies, assist with research compliance issues, and consult on research feasibility and special projects as needed.
  • Maintain a database for research study identification and tracking of study approval, enrollment and compliance activity.
  • Serve on interdisciplinary committees as needed.
  • Must have a Bachelor's degree in a health-related field.
  • Must have eight (8) years of experience working with patient care processes, as a clinician, researcher or professional in a clinical support service.
  • Must have three (3) years of experience working in clinical research, as an analyst or in an operational role.
  • Must have expert level knowledge of research terminology, design, study methods, ethics, and risk assessment.
  • Must have thorough knowledge of federal regulations specific to research, including human subjects' protection, drugs, devices, HIPAA regulations, Good Clinical Practices, coverage analysis, research billing and standards for collection, storage and transmission of research data.
  • Must be able to demonstrate knowledge of regulatory and Joint Commission standards pertaining to patient care within health care system.
  • Must have strong working knowledge of how research protocols translate into clinical and operational activities.
  • Must be able to demonstrate computer skills to input and extract information using word processing, spreadsheet, and database software.
  • Must be able to effectively communicate, both orally and in writing.
  • Must be able to employ effective problem solving and effective interpersonal skills.
  • Must be able to demonstrate patient-centered / patient-valued behaviors.
  • Research experience in a hospital setting.
  • Certification from a research-related professional organization (ACRP, HCCA, SoCRA, etc.) preferred.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service