Regulatory Assistants

Job Description

Job Description

At K2 Medical Research , we are transforming healthcare by delivering tomorrow’s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most.

K2 Medical Research is seeking a Regulatory Assistants to support our clinics out of Tampa or The Villages, FL . 

The Regulatory Assistant is responsible for maintaining regulatory documents pertaining to the clinical trials conducted at K2 Medical Research. This hybrid role will assist in 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 the organization's goals, missions, and values. 
• Good interpersonal, prioritization/organizational, and communication skills (written and oral).
• Ability to pivot projects and shift focus routinely depending on the Organization's needs. 
• Attention to detail.
• Handles confidential information appropriately.
• Takes initiative and participates as a team player.
• Self-Motivated, Goal-Oriented  
• Ability to think critically, solve problems, and take initiative when appropriate 
• Knowledgeable with MS Office, Outlook, and mastering new software and platforms 

Qualifications:

• Prefer 1 year of clinical research or regulatory experience

Your growth and well-being are our priority. Our comprehensive benefits package for full-time employees includes medical, dental, and vision options, supplemental insurance plans, 401(k) with immediate employer match, generous paid time off, and paid holidays. Most notably, we support a healthy work-life balance through a four-day work week, consisting of 10-hour shifts from Monday through Thursday. Fridays are reserved only for critical business needs or administrative tasks; otherwise, they are your chance to kick-start your weekend.

Join the K2 Family: Where Compassion and Connection Lead the Way! At K2 Medical Research, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff.

We are an equal opportunity employer. We celebrate what makes you uniquely you and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital, or veteran statuses.

We value the differences among our team members and are committed to providing reasonable accommodations for qualified individuals with disabilities. If you require a reasonable accommodation to participate in the job application or interview process, please contact View email address on ziprecruiter.com. We are here to ensure you have the support and tools you need to shine.