Regulatory Associate

At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida 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 the development and maintenance of regulatory documents pertaining to the clinical trials conducted at K2 Medical Research. The position will manage all aspects of study start-up, modification submissions, ongoing reporting, and study close-out to the Institutional Review Board (IRB) and the clinical trial sponsor. This role requires collaborating and interfacing with a variety of teams and excellent attention to detail. 

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 approvals 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.
• Ensure 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 binder or electronic regulatory platforms are updated at final monitoring closeout visits.
• Notification to Finance team as necessary to facilitate invoices.
• 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
• Strong customer service skills
• Ability to think critically, problem solve and take initiative when appropriate
• Knowledgeable with MS Office and Outlook

Qualifications:

• Prefer 2 or more years of clinical research or regulatory experience
• Bachelor's Degree and CCRP preferred

At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings:

• Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
• 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
• PTO of 16 days per year, 17 days after the first year of FT employment
• 9 paid Holidays
• K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.