Operational Compliance Specialist

3 days ago

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Care Access

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rare diseases • pulmonology • oncology • decentralized • decentralized trials

201 - 500

Description

• Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. • Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. • By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. • We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. • You will play a crucial role in leading and executing an operational quality compliance framework. • Your main objective will be to drive and deliver operational quality and process improvement initiatives, training, and compliance across the region.

Requirements

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials. • In depth knowledge and understanding of the requirements, best practice, and organisation of a clinical research site. • Worked as a clinical research auditor or clinical research associate (CRA) / clinical trials monitor (CTM) for at a minimum of 3 years and have had exposure to internal audits as well as Regulatory Body inspections. • Experience in training other members of staff at all levels. • Excellent communication skills and the ability to manage upwards successfully. • Ability to work independently, with minimal supervision, and be confident to make local decisions and escalate accordingly. • Willingness to travel on a regular basis. • Exceptional customer services skills to both internal and external stakeholders. • An understanding and experience of working within a matrix management environment. • Experience of working within a highly regulated environment. • Personal skills including assertiveness, persistence, flexibility, highly organized and detail oriented. • research Experience in managing Stressful situations and managing controversial issues whilst firmly adhering to the principles of the regulations and guidelines. • Expertise in reviewing, revising, and writing Standard Operating Procedures. • Ability to manage projects / teams of significant scope and complexity, while meeting all deliverables and timelines

Benefits

• PTO/vacation days, sick days, holidays. • 100% paid medical, dental, and vision Insurance. 75% for dependents • HSA plan • Short-term disability, long-term disability, and life Insurance • Culture of growth and equality • 401k retirement plan