Clinical Trials Operations Lead
2 weeks ago
Job Overview
We are seeking a seasoned Clinical Trials Operations Lead to join our team at Advarra. In this role, you will be responsible for driving service development and expansion, providing updates to leadership, and acting as the primary liaison and expert for assigned services across the company.
Key Responsibilities
- Work closely with the Business Operations Services team to drive service development and expansion.
- Provide Quality Assurance oversight and collaborate on required changes prior to delivering end product to the customer.
- Act as a subject matter expert within Advarra to ensure guidelines and builds are in accordance with the latest regulations and industry certification provider.
- Communicate with customers, including Clinical Trial Office administration, investigators, and study teams, upon completion of services requiring communication.
- Act as a liaison and escalation point for requested changes or questions from customers.
- Review, understand, and apply information in clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other relevant study-related documents when managing or conducting quality assurance.
- Define processes for internal and external workflows to ensure quality and efficiency, and excellent customer communication.
- Train or oversee the training of new United States based Business Operations Services team members performing coverage analysis and budget negotiation services ensuring quality and consistency of customer deliverables.
- Ability to be flexible to collaborate internationally as required.
Requirements
- High School diploma required.
- 5+ years of directly related experience in a clinical trials environment, and certification with the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) as a certified clinical research professional within three years of employment.
- Knowledge of FDA and Medicare regulations related to clinical trials is required.
- Medical coverage determination experience is required.
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