Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords
Some similar recruitments
Clinical Research / Finance Analyst - Remote, Must Reside In California
Recruited by Children's Hospital Los Angeles (CHLA) 8 months ago Address Los Angeles, CA, United States
Clinical Research Coordinator Jobs
Recruited by SMCI 8 months ago Address San Francisco Bay Area, United States
Clinical Research Coordinator Jobs
Recruited by Rady Children's Hospital-San Diego 8 months ago Address San Diego County, CA, United States
Regulatory Coordinator Iii/Clinical Researcher
Recruited by Cedars-Sinai 8 months ago Address West Hollywood, CA, United States
Dps Clinical Research Coordinator
Recruited by City of Hope 8 months ago Address Duarte, CA, United States
Research Associate Ii / Lvn, San Diego Clinical Trials (Durational W/Benefits)
Recruited by Kaiser Permanente 8 months ago Address , San Diego $63,500 - $82,060 a year
Clinical Research Scheduler Jobs
Recruited by UCLA Health 9 months ago Address , Los Angeles, 90095 $26.99 - $38.66 an hour
Clinical Research Analyst Jobs
Recruited by Intellectt Inc 9 months ago Address Alameda, CA, United States
Assistant Clinical Research Coordinator
Recruited by Stanford University 9 months ago Address Stanford, CA, United States
Ptsd Assistant Clinical Research Coordinator
Recruited by UC San Diego Health 9 months ago Address , San Diego, 92093, Ca $31.04 - $49.94 an hour
Clinical Research Assistant - Oncology
Recruited by Scripps Health 9 months ago Address La Jolla, CA, United States
Clinical Research Coordinator Jobs
Recruited by care.coach 9 months ago Address Millbrae, CA, United States
Clinical Research Coordinator Jobs
Recruited by Care Access 10 months ago Address Los Gatos, CA, United States

Clinical Research Regulatory Coordinator - Clinical Research

Company

Hoag Memorial Hospital Presbyterian
Address , Newport Beach, 92663, Ca
Employment type
Salary $32.61 - $50.16 an hour
Expires 2023-06-09
Posted at 1 year ago
Job Description
Salary Range: $32.6100 - $50.1600 /hour
The Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) in research efforts by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
  • Communicates and maintains a working relationship with WIRB ensuring institutional needs are met per Master Services Agreement.
  • Completes the External Visitors Checklist to meet badge requirements for access to the institution.
  • Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.
  • Work with Investigators to renew NCI/CTEP applications.
  • Remains informed of current federal, state, and local regulations regarding clinical research and communicates any changes to the study team.
  • Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.
  • Reviews informed consent for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.
  • Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, and monitoring/auditing requirements have been completed prior to the start of a study.
  • Produces and maintains regulatory binders prior to studies starting with all required documents and ensuring the dedicated electronic study folder is current.
  • Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems and develops and implements systems to decrease the delay in the approval process.
  • The Regulatory Coordinator ensures all research studies are compliant with regulations and maintains accurate and up-to-date regulatory files.
  • Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.
  • Reviews and completes CDAs for new studies; assist with assigning study codes.
  • Maintains working knowledge of current protocols and internal SOPs.
  • The Coordinator is the central resource for staff conducting clinical research.
  • Assists with the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for the maintenance of INDs or IDEs.
  • Provides study, enrollment updates, and SAE reports to Clinical Research Oversight Committee.
  • Works with multiple IRBs and understands the submission process and requirements.
  • Provides institutional authorization for new submissions with WIRB.
  • Participates in all investigator meetings, as required.

Education and Experience
  • One (1) year of regulatory documentation experience in clinical research preferred
  • Associate Degree or equivalent education and experience required
  • Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred