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.

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

The Quality Systems Manager is responsible for leading eQMS system design, implementation, system administration and ongoing maintenance. This role also provides support to the Quality Assurance Department through closely overseeing the quality and compliance of clinical work throughout the Company to ensure all systems and procedures undertaken are compliant with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements. With and in support of Quality Assurance Management, will coordinate and participate in specific projects and conduct activities in collaboration with other QA members.

What You'll Be Working On

Duties include but not limited to:

Quality System Management

· With input from key stakeholders, determine optimal workflow and configuration specifics related to electronic document management and related training, quality issues, CAPAs, audit issues and management, and reporting across all modules.

· Lead the eQMS system design, implementation, system administration and ongoing maintenance.

· Act as the eQMS primary system administrator, and lead for ongoing system management and maintenance.

· Provide support to the Quality Department through the creation, administration and maintenance of quality systems, trackers, programs and processes.

Overall Quality Support

· Track and report on quality assurance activities and metrics

· Conduct reviews of Care Access procedures, as required, to ensure alignment with quality standards and regulatory requirements.

· Work with other Care Access Departments to assist and provide guidance and support from a quality perspective.

· Investigate, analyze, and ensure the accuracy of information in quality data collection tools, contributing to reliable data-driven decision-making.

Audit Support

· Execute the yearly audit plan, conducting both internal and on-site audits

· Conduct routine internal audits, as required, to ensure consistency and compliance with Care Access SOPs, study protocols, ICH-GCP Guidelines, and other applicable regulatory requirements.

Other Responsibilities

Perform other duties as assigned. The duties listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Work on specific projects as assigned by Quality Assurance Management

Scope of Role

· Autonomy of Role: Work is performed under limited supervision

· Direct Reports: No

· Number of Direct Reports (if applicable):

· Role(s) Managing: Not applicable

Physical Requirements

· This role requires 100% of work to be performed in a remote office or clinical research site environment and requires the ability to use keyboards and other computer equipment.

Travel Requirements

· This is a remote position with up to 20% travel requirements. Occasional planned travel will be required as part of the role.

o Type of travel required: National

What You Bring

Knowledge, Skills, and Abilities:

· Prior experience with the design, implementation, system administration, and ongoing management of an enterprise eQMS solution, including electronic document management, training, quality issues, CAPAs, audit management, and reporting functionality.

· Excellent working knowledge of medical and research terminology

· Excellent working knowledge of federal regulations and good clinical practice (GCP)

· Attention to detail

· Ability to communicate and work effectively with a diverse team of professionals

· Strong Organizational Skills: Able to prioritize, delegate, direct, support and evaluate others work and follow through on assignments

· Communication Skills: Strong verbal and written communication skills as evidence by positive interactions with coworkers, management, clients and vendors

· Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals

· Strong computer skills with demonstrated abilities using clinical trials associated systems, electronic data capture, MS Word and Excel

· Ability to balance tasks with competing priorities

· Demonstrate effective decision-making skills

· Curiosity and passion to learn, innovate, able to communicate any possible risks and get things done

· Friendly, outgoing personality with the ability to maintain a positive attitude under pressure

· High level of self-motivation and energy

· Ability to work independently in a fast-paced environment with minimal supervision

· Must have a client service mentality

Certifications, Education, and Experience:

· Bachelor’s Degree or equivalent research experience

· 4 years of experience in Clinical Research and 3 years in Quality Assurance

Licenses:

· Not applicable

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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