Operational Compliance Associate-Warsaw, Poland
5 dni temu
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 clinical research experienced professional for the position of Operational Compliance Associate. As an Operational Compliance Associate, you will play a crucial role in supporting the execution of our operational quality and compliance framework at the Research Site level. Your main objective will be to oversee Operational Compliance at the site level ultimately increasing operational quality, efficiency, and long-term business success.
What You'll Be Working On
Duties include but are not limited to:
- Oversee the accuracy and quality of data for research projects within a designated research site.
- Develop, maintain and produce dashboard metrics for site recruitment, participant statuses and operational quality metrics for research projects within a designated research site.
- Oversee the Data and Quality Processes within a designated site, which include PI Oversight, Delegation Log checks, and SAE reporting tracking.
- Oversee the implementation of best practices within a designated site to pre-empt quality issues.
- Collaborate with the Operational Compliance Team with the management of quality issues reported in the Care Access Quality Management System specific to a designated site.
- Collaborate with the Operational Compliance Team for the facilitation and participation of Root Cause Analysis.
- Complete operational compliance checks on clinical trial records for a designated site ensuring that source data, CRF and ISF records are accurate complete and inspection ready at all times.
- Ensure designated site staff are compliant with regulatory, client and or Sponsor requirements and or expectations.
Physical and Travel Requirements
This is a site based role and travel will be less than 10%.
What You Bring
Knowledge, Skills, and Abilities:
- Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
- Knowledge and understanding of the industry requirements, best practice, and organization of a clinical research site.
- Minimum of 3 years industry experience and have had exposure to internal audits as well as Regulatory inspections.
Certifications/Licenses, Education, and Experience:
- Minimum of 3 years of industry 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 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.
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