REGULATORY ASSISTANT

K2 Staffing LLC • Clermont, FL

21h • Hybrid

About The Position

K2 Medical Research is seeking a Regulatory Assistant to support the Winter Garden, FL clinic. 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.

Requirements

• 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

Nice To Haves

• Prefer 1 year of clinical research or regulatory experience

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.

Benefits

• Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
• 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
• PTO of 16 days per year, 17 days after the first year of FT employment
• 9 paid Holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed