The Regulatory Associate manages the development and maintenance of regulatory documents for clinical trials, including study start-up, IRB submissions, and close-out procedures. They also collaborate with clinical operations and sponsors to ensure audit-ready regulatory files and compliance with protocol requirements.
Requirements summary
The role requires at least 2 years of clinical research or regulatory experience and a Bachelor's degree. Proficiency in MS Office and strong organizational and communication skills are essential for success in this position.
bachelor degreeMS OfficeOutlookCommunication skillsInterpersonal skillsAttention to detailProblem solvingRegulatory complianceClinical operations supportRegulatory documentationAdverse event reportingClinical trial managementIRB submissionProtocol deviation reportingInformed consent form developmentDelegation of authority logs
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 Associate to support our facilities out of The Villages, FL.
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
Benefits
Dental insurance
Vision insurance
Medical insurance
Paid holidays
Paid time off
Supplemental insurance plans
401(k) with immediate employer match
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, and 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
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 Talent@k2med.com. We are here to ensure you have the support and tools you need to shine.
