Operational Compliance Specialist
Care Access Research
Legal
United States · Remote
Posted on Nov 1, 2024
What We Do
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.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
We are currently seeking a dedicated and experienced professional for the position of Operational Compliance Specialist. As an Operational Compliance Specialist, 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, ultimately increasing operational quality, efficiency, and long-term business success.
What You'll Be Working On (Duties include but are not limited to):
· Complete operational compliance checks on clinical trial documents at sites.
· Maintain a quality and compliance role within operations, separate from operational quality control (QC) and routine operational activities.
· Provide quality focused support to the business so that regulatory compliance and commercial objectives are achieved.
· Assist clinical operational staff with Quality Issue Management, Corrective Action and Preventive Action Plan (CAPA) definition to ensure adequacy, robustness, and compliance with Standard Operating Procedures (SOPs), regulations and best practice.
· Maintain a CAPA owner listing and robust mechanisms for ensuring quality findings and CAPAs are addressed, implemented and effective.
· Escalate issues to management/QA.
· Support staff with process improvement and procedure definition and process mapping, where applicable.
· Facilitate and report root cause analysis to aid CAPA definition and process improvement, where applicable.
· Establish and maintain processes, procedures, and minimum expectations for operational compliance (OC), including, but not limited to:
o Oversight of quality control (QC), CAPA and process effectiveness
o Process for OC assessments, including scope/purpose/responsibilities.
o A risk-based approach
o Local OC activity schedule
o Process for OC output reporting, trending, distribution, follow up and CAPA definition.
o Identify operational quality performance measures, collate metrics on data generated within operational compliance and provide required metrics/RAG reports to management, as appropriate.
· Ensure operational quality, participant safety and data integrity are at the forefront of all activities through review and interpretations of quality reports (e.g., audit reports, noncompliance, inspection output, complaints) and specific activities undertaken via operational compliance.
· Support internal governance structures to facilitate quality, process improvement and compliance within operations.
· Support development and delivery of client governance/quality agreements in conjunction with QA and operational management.
· Support the QA function with regards to notification, preparation and facilitation of client audit and regulatory inspections, investigations of non-compliance and tracking and follow up of CAPA status ensuring on time completion of quality related tasks.
· Maintain effective relationships internally and externally, for efficient and effective delivery of service.
· Comply with company quality framework, regulatory (GCP) legislation, guidelines, and international standards.
· Provide training on functional GCP, and other compliance and quality related topics, as required to improve quality and expertise within the operation of the research centres.
· Safeguard confidentiality of staff, participant and sponsor matters as required by regional Data Protection and Good Clinical Practice expectations.
Physical and Travel Requirements
- Candidates must be willing to travel up to 30% of the time nationwide. Frequency and length of travel may depend on need for on-site visits.
What You Bring (Knowledge, Skills, and Abilities):
- 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
Certifications/Licenses, Education, and Experience:
- 5 years of relevant experience
Benefits (US Full-Time Employees Only)
- 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
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
