Regulatory Associate

2 weeks ago

Winter Garden, United States K2 STAFFING LLC Full time
Job DescriptionJob Description

At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.

Description:

The Regulatory Associate is responsible for ensuring compliance with regulatory requirements for all stages of clinical trials and processing of regulatory packets/documents, maintenance of regulatory documents, ensuring adherence to relevant guidelines. The role is critical to fascinating the smooth execution of clinical trials while maintaining the highest standards of compliance. You will collaborate with cross-functional teams to prepare, submit and maintain regulatory documents, ensuring adherence to relevant regulations and guidelines.

Primary Responsibilities:

Prepare regulatory documents for new study submissions to IRB and sponsor

Maintain regulatory files at audit-ready status at all times by ensuring filing are up-to-date upon completion of the processing of new or revised documents

Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.

Receive, track, and distribute IND Safety Reports to the Principal Investigator for acknowledgement of review and file. Submit IND Safety Reports to the study-assigned IRB if submission is not handled by the sponsor

Inform clinical operations of new study approvals including at initiation, amendments, and consent forms upon receipt. Ensure documents are distributed to the clinical team as appropriate and filed

Communicate and update Sponsor with any revised site information and notify the IRB as required

Liaison with IRBs on a frequent basis to ensure resolution of outstanding submissions requests

Learn and utilize IRB electronic web portals for the processing of study submissions

Distribute IRB feedback on new study submission to the clinical team and sponsor for resolution of questions or Board requests

Manage the development of new Informed Consent Form drafts with the IRB, as needed, and ensure agreement with ICF language between K2 Medical Research Clinical Operations teams, IRB, and Sponsor

Obtain Clinical assignments from the Operations teams for the development of new Delegation of Authority Logs and inform teams of missing information or needs for updates to the Logs

Verify protocol training is captured and returned to the regulatory department prior to the assigned staff members completing the Delegation of Authority Logs

Ensure all regulatory books are updated at final monitoring closeout visits

Inform assigned individuals of the need for archiving assistance of closed regulatory books at the defined time frame for long-term storage

Liaison with sponsor monitors during routine and closeout monitoring visits to ensure resolution of outstanding regulatory document requirements are attended to within an appropriate time frame

Schedule monitoring visits, prep books, and assign monitoring space as requested

Provide team assistance on all projects as needed

Assist in the tracking of the status of new study submissions status

Perform ad-hoc projects and/or general office duties as necessary

Other duties as assigned

Knowledge, Skills, Abilities:

  • Learn and support the organization goals, missions, and values
  • Good interpersonal, planning/organizational, and communication skills (written and oral)
  • Ability to handle multiple tasks/projects simultaneously
  • Attention to detail
  • Handles confidential information appropriately
  • Takes initiative and participates as a team player
  • Knowledgeable with MS Office and Outlook

Qualifications:

  • Ideal candidate would have a minimum of 2 years clinical research or regulatory experience.

  • Bachelor's Degree and CCRP preferred

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