OCRST IIT Regulatory Affairs Coordinator (Open-Rank)

University of Colorado

1d•Hybrid

About The Position

The Cancer Center Oncology Clinical Research Support Team (OCRST) is responsible for providing central management and oversight for Investigator-Initiated Trials (IITs) at the CU Cancer Center. The Regulatory Affairs Coordinator (RAC) works with investigators and OCRST members in the development and implementation of IITs. This position is responsible for completing regulatory start up and maintenance tasks. The position will also be responsible for submissions to the Food and Drug Administration (FDA), with heavy emphasis on Investigator New Drug applications, but sometimes includes device submissions, as required for IITs. This position communicates appropriately and effectively with Principal Investigators, study investigators, other team members, and regulatory bodies such as FDA, Colorado Multiple Institutional Review Board (COMIRB), the Protocol Review & Monitoring System (PRMS), the IND/IDE Office, and UCHealth Research Administration (UCH-RA). Thus, outstanding customer service skills and participating in ongoing efforts to improve regulatory practices, procedures, and workflows is essential.

Requirements

Bachelor’s Degree focused in Health Sciences (e.g., Pharmacy, Public Health, Nursing), Life Sciences (e.g. Biology, Chemistry, Physiology), Law, or related fields of study.
Substitution: Work experience in a related field can substitute for the Bachelor’s degree on a year for year basis.
One (1) or more years of research, regulatory, or compliance experience.
ACRP, SOCRA, or RAC certification within one year of hire is required.
Two (2) or more years of research, regulatory, or compliance experience with at least one (1) year regulatory or compliance experience in clinical research.
ACRP, SOCRA, or RAC certification is required.
Maintenance of this certification is required.
Applicants must meet minimum qualifications at the time of application.
Applicants must be legally authorized to work in the United States without requiring sponsorship.

Nice To Haves

Understanding of medical terminology and technical writing experience.
Oncology research and/or academic center regulatory experience.
Experience with submissions to IRBs, and/or the FDA for INDs or IDEs.
Experience working with IITs.
Experience handling and prioritizing detailed tasks and meeting deadlines.
OnCore/eReg and/or InfoEd experience.
Ability to problem-solve and multi-task in high volume settings.
Understanding of research standards as set forth by FDA, ICH, OHRP, UCH, UCD and NCI.
Self-motivated and directed, with keen attention to detail.
Ability to work independently.
Excellent communication skills both written and verbal.
Proficient in Microsoft systems, especially Teams, Word, Excel, and PowerPoint.

Responsibilities

Ensures compliance with institutional, state, federal, and drug/device or financial partners’ regulations.
Serves as regulatory contact person for IITs and meets with Principal Investigators as well as in-house staff for review of regulatory records.
Assists Principal Investigators and Clinical Project Coordinator(s) in the development of the protocol and subsequent amendments for IITs to ensure standardization and adherence to University and Cancer Center, FDA and GCP policies, and guidelines for IITs.
Drafts and maintains FDA Forms (e.g., 1571, 1572, 3674), Financial Disclosure Forms or other regulatory documents as requested by OCRST Regulatory Affairs Manager or RACs.
Drafts and maintains IND applications/IDE submissions to FDA and correspond with agency as needed.
Writes clear and accurate consent/HIPAA documents.
Completes required applications, forms/documents for submission to regulatory agencies, including COMIRB, PRMS, and other regulatory bodies as required.
Maintains regulatory documentation for the lifetime of study.
In collaboration with Clinical Project Coordinator, compiles summary of changes document and other necessary documents for submission of protocol amendments to study/support sponsor and/or regulatory bodies for review and approval.
Prepares and maintains the regulatory binder for review by monitors and auditors, including preparation for monitoring/auditing visits and assists with resolution of regulatory queries.
Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting.
Works closely with multiple study/support sponsors’ web portals to:
Download safety updates and compile for PI review
Download study template documents and pharmacovigilance documents (i.e., Investigator’s Brochure)
Upload study approval documents
Compiles and submits study documents or progress reports to funding partners as required, independently completes, and submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the Cancer Center for assigned projects.
Serves as back up coverage during RAC absences.
Collects essential documents from participating trial sites and participates in regulatory communication for single site clinical trials.
Updates OnCore and/or eReg with regulatory review information, documents, or other information in accordance with Standard Operating Procedures (SOPs), guidance documents, or work instructions.
Independently manages and provides support to more complex, higher acuity, or multi-site research studies.
Participates in onboarding and training activities for new members of the Regulatory team; serves as back up coverage during team absences.
Manages essential document collection and site regulatory communication for single site and multi-center clinical trials.
Maintains site regulatory communication for multi-center clinical trials.
Recommends and drafts enhancements to IIT Team SOPs, guidance documents, or other tools/templates pertinent to regulatory activities.
Participates with OCRST Regulatory Affairs Manager and staff in discussions and activities to identify and implement ways to improve regulatory practices, procedures, and workflows.
Creates and maintains Trial Master File for applicable trials. Provides guidance and support to external sites during start up process to ensure timely filing of all regulatory requirements.
Assists in development of Cancer Center SOPs, guidance documents, work instructions, and process workflow for IITs.
Assists OCRST Regulatory Affairs Manager with resolving issues by utilizing independent judgement, discretion, creativity and analytical thinking.
Collaborates with OCRST Regulatory Affairs Manager and staff to identify and implement ways to improve regulatory practices, procedures, and workflows.
Acts as OCRST representative in Cancer Center initiatives and willingly accepts additional responsibilities and duties as assigned by management.
Delegates tasks appropriately to student worker and/or Regulatory Affairs Coordinator I and II, oversees work performed on delegated tasks.
Acts as mentor to and participates in planning for and onboarding activities for new members of the Regulatory Affairs team.
Problem solves with other Regulatory Affairs Coordinators and Regulatory Manger when issues arise and collaborates with OCRST Regulatory Affairs Manager to define training and onboarding requirements and plans for new staff.
Presents educational topics for initial or refresher training as part of new hire onboarding and at team meetings.