Regulatory Specialist

Welcome to Piedmont Cancer Institute - not just a workplace, but a partner in patient care.

Piedmont Cancer Institute ("PCI") has served patients in the Atlanta area for over 36 years. We currently have 20 APPs and 17 physicians and 5 locations serving the greater Atlanta area and we are growing.

At PCI, we strive to deliver the best possible comprehensive patient care, using leading-edge cancer therapies, dedication to excellence and compassion in care.

Regardless of your profession, you will find more than a job at PCI. You will find a meaningful career.

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description :

Duties and 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 assess protocols and present 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, correctly de-identifies data, as necessary. Assures HIPPA requirements are met.
• Assist Research Coordinators and other Regulatory Assistants in the day to day research activities in an efficient, productive, and professional manner
• Communicates with Sponsor or delegated authority (CRO, Monitor) in a timely and professional manner.
• Submit and monitor FDA and IRB regulatory requirements for protocols (Regulatory documentation to include submissions of 1572 forms, IRB submission forms for approvals, revisions, renewals; adverse event reporting, study closures, suspensions, and addition of new investigators, etc.) for assigned studies.
• Maintain current protocols with revisions, amendments and current IRB approved informed consents and file in appropriate files and binders for assigned studies.
• Communicates effectively with physicians and other research staff regarding protocol amendments, safety, and procedural changes. Assure all research staff has been provided copies of protocols, amendments, IB, correspondence and / or other training material. Maintain department records of training for assigned studies.
• Maintain records of all deviations and SAE's and submit appropriate notifications to IRB's and Sponsors
• Prepare reports, take minutes and prepare necessary documents for research team meetings as requested.
• Prepares, distributes and file 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 for assigned studies. Assists sponsors and monitors as needed
• Assists with maintaining and submitting screening and enrollment logs as required by study protocol
• Maintains site master files (CVs, CLIAs, Lab normal ranges, Memos, Licenses, etc.), archives documents as needed
• Ensures all closed studies are archived appropriately. Maintains Sponsor contact for determining destruction of old files and maintains documentation. Maintains master file of archive activities
• Attend department, staff and other research meetings
• Assist with additional department needs as necessary
• 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 but not limited to Human Subject Protection training, HIPPA training, training for shipping diagnostic specimens, CPR and GCP training.
• Performs related work as required
• Other duties as assigned

Qualifications and Requirements :

HIPAA Requirements :

Regulatory Specialist will have access to PHI and ePHI in the course of his / her duties. Applying the minimum necessary standard of HIPAA, this employee has access to the minimum amount of designated record sets required to perform his or her duties.

Interpersonal :

Develops and maintain effective relationships with research staff. Communicates effectively in both print and speech. Skill in preparing and presenting reports. Ability to remain calm and poised in urgent situations.

Critical Thinking :

Planning and organizing. Skill in exercising imitative, judgment, problem solving and decision-making. Skill in development of comprehensive reports and interpretation of complex operations. Ability to set priorities and avoid crises management.

Demands of Position :

Requires sitting, walking, some bending, stooping, stretching, and lifting or moving materials anywhere up to possibly 50 lbs.

Typical Working Conditions :

Normal office environment

Machines, Equipment, Work Aids :

Computer, printer, copier / scanner, telephone, voicemail, and fax

Job Type : Full-time

Pay : From $32.00 per hour

Schedule :

Ability to Relocate :

Work Location : In person

Salary : $32