K2 Medical Research ยท 2 weeks ago
REGULATORY ASSISTANT
Maitland, FL
Full-time
Hybrid
Entry Level
1+ years expK2 Medical Research is seeking a Regulatory Assistant to support the Maitland (Orlando), FL clinic. The role involves maintaining regulatory documents for clinical trials and requires collaboration with various teams, proficiency with technology, and attention to detail.
Clinical TrialsHealth CareHealth DiagnosticsMedical
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
Qualification
Required
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
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
Preferred
Prefer 1 year of clinical research or regulatory experience
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
Company
K2 Medical Research
K2 Medical Research is a clinical research center that specializes in conducting clinical trials.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
TPG
2024-06-17Private Equity
Leadership Team
Sean Stanton
Founder
Recent News
2025-01-09
Company data provided by crunchbase