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CLINICAL RESEARCH REGULATORY COORDINATOR - HIRE

Department:  Allied Health
Status:  Full Time
Shift:  1st

The Clinical Research Regulatory Coordinator will support 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. Will be responsible for ensuring that all research studies are compliant with regulations as well as maintain accurate and up-to-date regulatory files. Will serve as a central resource for staff conducting clinical research. This position reports to the Director, Clinical Research.

 

Essential Functions:

  • Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.
  • Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.
  • Remains informed of current federal, state, and local regulations regarding clinical research and communicate any changes to the study team.
  • Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease the delay in the approval process.
  • Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study.
  • Will produce, as applicable, and maintain regulatory binders prior to studies starting with all required documents and ensure dedicated electronic study folder is current.
  • 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; assists with assigning study codes.
  • Works with external researchers to complete External Visitors Checklist to meet badge requirements for access to the institution.
  • Reviews informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.
  • Works with multiple IRBs and understands their submission process and requirements. Provides institutional authorization for new submissions with WIRB.  Communicates and maintains a working relationship with WIRB to ensure institutional needs met per Master Services Agreement.
  • Provides study, enrollment updates and SAE reports to Clinical Research Oversight Committee.
  • Work with Investigators to renew NCI/CTEP applications.
  • Participates in required teleconferences, on-site meetings, and off-site investigator meetings, as required.
  • Maintains working knowledge of current protocols and internal SOPs.
  • Communicates regularly with Research Staff to review data accuracy, clinical data quality, and overall study progress.
  • Assists in the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs or IDEs.
  • Perform other duties as assigned.

In addition to the above:

  • Designs, implements and manages a system for organizing, planning workflow related to all research regulatory study activities. Prepares and presents a summary of clinical trial activities if needed.
  • oversees new study submissions to the regulatory authorities, IRB, and sponsors including initial submissions, amendments, safety reports, deviations, etc. to ensure timely, accurate submissions Maintains staff credentials including the CV, licenses, conflict of interest, etc.
  • Serves as primary IRB contact & provides institutional authorization for new submissions.
  • Design and/or maintain organizational tools to conduct the study accurately and in compliance with Good Clinical Practice. Develops forms, checklists, and other tools to facilitate study completion and compliance.
  • Manages and communicates issues with the CITI online training program.
  • Documents and tracks research training of investigators and research staff.
  • Registers & maintains clinical trials on the clinicaltrials.gov website for applicable studies & works with sponsors to include Hoag.
  • Maintains and updates the study management portion of the clinical trial management system.
  • Maintains share drive, master study sheet, departmental Wave website, and clinical research files.  Tracks SAEs & inputs into clinical research database on a needed basis.
  • Maintains Institution’s Federal Wide Assurance.
  • Assists in the development and maintenance of SOPs including work instructions, forms, and templates.
  • Work with Director of Clinical Research and Cancer Institute leadership, including USC, staff including the Cancer Clinical Investigations Support Office (CISO) to activate new and maintain on-going research studies associated with USC including but not limited to IRB processes, USC systems (Café, iStar, etc.), pertinent informed consent language, etc.
  • Maintain pertinent clinical trial regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission database and file systems. Ensure that information of such regulations and requirements, especially those that are new or modified, are distributed to the study team and other appropriate personnel.
  • oversees non-Sr. staff for work completion

 

Education, Training, and Experience

 

Required:

  • Associate degree or equivalent education required.

 

Preferred:

  • One (1) year of experience in the field of regulatory documentation management or clinical research required.
  • Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines. 

 

Sr Clinical Research Regulatory Coordinator

In addition to the above:

Required:

  • Bachelor’s Degree
  • Extensive knowledge in a clinical area designated

 

Skills or Other Qualifications

 

Required:

  • Excellent communication skills and superb attention to detail.
  • Excellent interpersonal skills and customer service focus is required.
  • Strong writing and organizational skills.
  • Able to work in a fast-paced environment with flexibility and autonomy.
  • Must be able to prioritize tasks on a daily basis.
  • Computer knowledge in Microsoft Windows applications including Word, Outlook, and Excel and familiarity with electronic data capture systems preferred.

 

 

License and Certifications

 

  • Required: N/A

 

Preferred: Holds current ACRP or SOCRA certificate

 

Sr. Clinical Research Regulatory Coordinator

  • Required: Holds current ACRP or SOCRA certificate
  • Preferred: N/A


Nearest Major Market: Orange County
Nearest Secondary Market: Los Angeles

Job Segment: Clinic, Regulatory Affairs, Medical Research, Clinical Research, Healthcare, Legal, Research

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