Regulatory Assistants

K2 Medical Research is seeking a Regulatory Assistants to support our clinics out of Orlando (Maitland) FL. The Regulatory Assistant is responsible for maintaining regulatory documents pertaining to the clinical trials conducted at K2 Medical Research. This hybrid role will assistin duties related to eRegulatory filing and processing of essential documents for all phases of the study trial. This role requires collaboration and interfacing with a variety of teams proficiency with technology and excellent attention to detail.

Primary Responsibilities:

• Maintain regulatory files at audit-ready status at all times by ensuring document filing training and essential site files are up-to-date upon completion of the processing of new or revised documents.
• Provide support to the site Regulatory Associates reports to the Associate Director of Regulatory Affairs.
• Hybrid Role providing support for 1-2 days on-site with the K2 Central Florida Network 1-2 days remote.
• 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.
• Distribute IRB approvals on new study submissions to the clinical team and sponsor for resolution of questions or Board requests.
• Obtain assignments and deadlines from the Associate Director of Regulatory Affairs Manager/Clinical Teams
• Ensure protocol training is captured and returned to the Regulatory Department before the assigned staff members complete the Delegation of Authority Logs.
• Ensure all Regulatory Binders or Electronic Regulatory Platforms are updated at final monitoring closeout visits Routine Monitoring visits Audits and SIV as directed by the Associate Director of Regulatory Affairs
• Perform ad-hoc projects and/or general office duties as necessary.
• Assist with document completion / red line changes as requested.
• Assist with completing action items on routine Quality reviews.
• Assist with onboarding and routing training in eRegulatory for new staff.
• Prepare Regulatory Documents for new study submissions to the IRB and Sponsor
• To provide backup site coverage across network in person or remotely.
• File from site Repository to eRegulatory platform.

Knowledge Skills and Abilities:

• Learn and support theorganizationsgoals missions and values.
• Good interpersonal prioritization/organizational and communication skills (written and oral).
• Ability topivot projectsand shift focus routinely depending on the Organizationsneeds.
• Attention to detail.
• Handles confidential information appropriately.
• Takes initiative and participates as a team player.
• Self-Motivated Goal-Oriented
• Ability to think criticallysolve problemsand take initiative when appropriate
• Knowledgeable with MS OfficeOutlook and mastering new softwareand platforms

Qualifications:

• Prefer 1 year of clinical research or regulatory experience

Join the K2 Family: Where Compassion and Connection Lead the Way!

At K2 Med people come first and were seeking warm wonderful humans who effortlessly click with everyone from our incredible patients to brilliant physicians and dedicated research staff. We thrive on empathy a patient-first approach and absolutely zero big egos (unless its an ego about being extra kind then well allow it!). We believe a supportive caring experience is paramount for our patients and that starts with you.

We celebrate what makes you uniquely you! Your race color religion marital status age national origin or even your favorite snack (though were partial to good research snacks) dont define your talent or fit here. If you need a little extra support or accommodation due to a disability no sweat! Just reach out to our friendly team at and well ensure you have everything you need to shine.