Regulatory Assistants
K2 Medical Research
Summary
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.
Job description
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.
Requirements
- Prefer 1 year of clinical research or regulatory experience
- Good interpersonal, prioritization/organizational, and communication skills (written and oral)
- 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
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Supplemental Insurance
- 401(k) With Immediate Employer Match
- Paid Time Off
- Paid Holidays
- Four-Day Work Week
Company overview
K2 Medical Research is a privately-owned clinical research organization (CRO) headquartered in Orlando, Florida, with multiple research facilities across Florida, Tennessee, and Rhode Island. Founded in 2021, the company specializes in conducting multiphasic clinical trials that advance the development of innovative medical treatments while ensuring participant safety and privacy. K2 operates under the mission "Tomorrow's treatment today," focusing on connecting patients with cutting-edge therapies while contributing to medical progress. The company conducts research across diverse therapeutic areas including Alzheimer's disease, Parkinson's disease, depression, anxiety, NASH/fatty liver disease, migraines, diabetes, vaccines, and cardiovascular conditions. With a network of clinical research sites and a team of experienced physicians and researchers, K2 Medical Research emphasizes the concept of Clinical Research as a Care Option (CRAACO), positioning clinical trials as viable alternatives or supplements to conventional healthcare. The company has completed over 5,000 clinical trials and maintains a strong community outreach program focused on health equity and inclusive research practices.