Regulatory Specialist

Job highlights:

The Regulatory Affairs Coordinator is responsible for maintaining the Regulatory Binders up to date and working closely with Sponsors, CROs, and IRBs to facilitate the timely turnaround of study documents, ensuring there is adequate Regulatory oversight. All duties are carried out in accordance with the company policies, SOPs, and Good Clinical Practice (GCP) as well as all applicable Local, State, and Federal regulations. Job functions:

• Accesses the IRBs portals for daily updates.
• Interacts with Sponsors/CROs and Site staff to exchange relevant information and study updates.
• Work with study staff to expedite start-up activities and enhance the Site activation.
• process, while ensuring all activation accesses and requirements have been met.
• Collects, reviews, and submits essential Regulatory documents.
• Updates Trust with updated Informed Consent Forms and Protocol Amendments.
• Oversee initial submission, collection, and maintenance of central and current IRBs and documents.
• Ensures filing of IRB-approved documents i.e., Protocol and Protocol amendments, Investigators Brochure, Recruitment materials, interim and approval reports, etc.
• Registers and coordinates Investigators' meeting schedules, including monitors visits.
• Review the Regulatory Binder before monitoring visits.
• Ensures all Regulatory items are filed under the appropriate section.
• Reviews Delegation of Authority logs are appropriately updated by PI’s as necessary.
• Able to identify, escalate, and resolve issues before they become critical.
• Proposes alternatives to improving Regulatory workflow.
• Reviews 1572 FDA Form for errors.
• Collects signed Financial Disclosure Forms from Investigators.
• Ensures that offsite facilities working in the study are also included in the 1572and verify they receive training and accesses required by the Sponsor.
• Updates Regulatory documents as needed.
• Learns and utilizes various reporting tools.
• Resolves all queries related to the Regulatory matters left by Clinical Research Associates within a week of them being issued.
• Accurately maintains data in the Site’s system.
• Provides training and assists as liaison between the Sponsors and the Clinical Research Coordinators.
• Accesses Sponsor’s specific portals such as Exostar, CPAC, SIP, Clinergize, Firecrest, Investigator Space, Longboat, for new communications and INDs.
• Assists with preparation for FDA Inspections, Sponsor audits, and Internal audits.
• Reviews and resolves Sponsor, CRA, CRC or supervisors request in a timely manner.
• Completes additional tasks as required by a specific protocol.
• This position reports to the Regulatory Affairs Manager.

Desired qualifications:

• Works well in a team environment.
• Familiarity with Clinical Terminology preferred.
• Excellent written and verbal communication skills.
• High attention to detail and organization.
• Clinical Research experience preferred.
• Adjusts quickly to environmental changes and shifting priorities of the dynamic organization.
• Bi-lingual English/Spanish required.
• Ability to work after hours and weekends if needed.
• Knowledge of Microsoft Office 365.

Minimum requirements:

• Associate degree required; bachelor’s degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, and experience.

Benefits:

• Medical, GAP, Dental, and Vision Insurance
• Life Insurance (includes Will Preparation, Employee Assistance Program (EAP), and Travel Assistance)
• Short & Long-Term Disability
• Workers’ Compensation Insurance
• COBRA Continuation Coverage
• 401(k) Retirement Savings Plan with employer match up to 4%.
• Paid Time Off
• Paid Holidays
• Bereavement Leave
• Family and Medical Leave Act (FMLA)
• Military Leave
• Referral Program
• Tuition Assistance/Professional Development
• Certification Reimbursement

Job Type: Full-time

Pay: $24.00 - $31.00 per hour

Expected hours: 40.0 per week

Benefits:

• 401(k)
• 401(k) matching
• Health insurance

Work Location: In person

Salary : $24 - $31