Regulatory Specialist

Piedmont Cancer Institute P.C • Atlanta, GA

407d • $66,560 - $66,560

About The Position

The Regulatory Specialist at Piedmont Cancer Institute plays a crucial role in ensuring compliance with regulatory agencies and promoting Good Clinical Practice in clinical trials. This position involves assisting research coordinators, maintaining regulatory documentation, and ensuring the safety and welfare of study patients. The specialist will also communicate effectively with various stakeholders and participate in the development and revision of departmental policies and procedures.

Requirements

• Bachelor's degree preferred
• 5 years research experience required with a minimum of 3 years in Regulatory Oncology background preferred
• Knowledge and understanding of clinical trial protocols, IRB regulations and requirements, human subject's protection in research setting, ICH Good Clinical Practice guidelines
• Skill and experience interpreting medical charts and abstracting data from medical records
• Ability to organize and coordinate multiple tasks
• Ability to work in a changing, multi-demand setting to prioritize a large volume of work and meet deadlines efficiently
• Requires strong written, verbal, and problem-solving skills
• Requires strong computer skills in word processing, and using a spreadsheet, database entry, Internet applications
• Proficient in Microsoft Office products

Nice To Haves

• Experience with clinical trials
• Knowledge of oncology practices

Responsibilities

• Ensures compliance with multiple regulatory agencies
• Promotes Good Clinical Practice in the conduct of all clinical trials
• Assists Research Coordinators to ensure the safety and welfare of study patients
• Demonstrates excellent customer service
• Reviews and assesses protocols and presents questions/concerns to Investigators, Clinical Research Coordinator, and Clinical Research Manager as necessary
• Remains up to date on current protocols, amendments, and new protocols
• Handles information confidentially and correctly de-identifies data as necessary
• Assures HIPAA requirements are met
• Assists Research Coordinators and other Regulatory Assistants in day-to-day research activities
• Communicates with Sponsor or delegated authority in a timely and professional manner
• Submits and monitors FDA and IRB regulatory requirements for protocols
• Maintains current protocols with revisions, amendments, and current IRB approved informed consents
• Communicates effectively with physicians and other research staff regarding protocol amendments, safety, and procedural changes
• Maintains department records of training for assigned studies
• Maintains records of all deviations and SAE's and submits appropriate notifications to IRB's and Sponsors
• Prepares reports, takes minutes, and prepares necessary documents for research team meetings
• Prepares, distributes, and files Safety IND Reports
• Assists Clinical Research Manager in the formulation, review, and revision of department policies, procedures, and guidelines
• Participates in study initiation, monitoring, and close-out visits
• Prepares for site monitoring visits and has source documents, CRFs, and regulatory binders available for monitor
• Assists sponsors and monitors as needed
• Assists with maintaining and submitting screening and enrollment logs as required by study protocol
• Maintains site master files and archives documents as needed
• Ensures all closed studies are archived appropriately
• Maintains Sponsor contact for determining destruction of old files
• Attends department, staff, and other research meetings
• Participates in professional development activities to keep current with health care and research trends and practices
• Maintains and performs internal audits and assists with external quality assurance audits on all protocol and regulatory documents
• Maintains required training including Human Subject Protection training, HIPAA training, and GCP training

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree