Clinical Trials Regulatory Specialist

The US Oncology Network; Salem (VA); In loco; USD 32.000 - 48.000; Tempo pieno

Descrizione del lavoro

The US Oncology Network in Salem, VA is seeking a research regulatory affairs professional to oversee regulatory activities for clinical trials under minimal supervision. You will manage study regulatory documents, support QA initiatives, and ensure compliance with SOPs, GCP, OSHA and HIPAA across site activities.

Responsibilities include coordinating feasibility questionnaires, regulatory document control, audits, IRB submissions, and training staff on regulatory processes, with opportunities

Competenze

• High School Diploma required; Associate's degree preferred.
• Minimum 3 years of experience in clinical research, regulatory affairs and/or an oncology related field.
• Experience working with Sponsor Monitor representatives.
• Excellent communication skills, strong ability to multi-task, and high attention to detail.

Mansioni

• Track and complete protocol feasibility questionnaires; coordinate document collection for timely trial openings.
• Maintain Protocol Regulatory Documents per SOPs and regulations.
• Coordinate audits, study start-up visits and close-out visits; communicate regulatory issues to staff and investigators.
• Prepare Informed Consent Documents and regulatory packets for sponsor/IRB submissions; coordinate IRB submissions.
• Collect and organize training documents; participate in study initiations and educational programs.

Conoscenze

Regulatory compliance

Communication skills

Time management

Interpersonal skills

Attention to detail

Multi-tasking

Formazione

High School Diploma

Associate's degree

Strumenti

Microsoft Office

Descrizione del lavoro

The US Oncology Network in Salem, VA is seeking a research regulatory affairs professional to oversee regulatory activities for clinical trials under minimal supervision. You will manage study regulatory documents, support QA initiatives, and ensure compliance with SOPs, GCP, OSHA and HIPAA across site activities.

Responsibilities include coordinating feasibility questionnaires, regulatory document control, audits, IRB submissions, and training staff on regulatory processes, with opportunities