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 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
Join the K2 Family: Where Compassion and Connection Lead the Way!
At K2 Med, 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 thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll 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 we're partial to good research snacks) don't 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 [email protected], and we'll ensure you have everything you need to shine.
