<p>Location: Remote, US</p><br/><p>Employment Type: Full time - Temporary</p><br/><p>Team: Supply Chain & Infrastructure</p><br/><div><b style="font-size: 13pt">&nbsp;</b></div><div><b style="font-size: 13pt">What We Do</b></div><div><span style="font-size: 12pt">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.</span></div><div><span style="font-size: 10.5pt">&nbsp;</span></div><div><b style="font-size: 13pt">Who We Are</b></div><div><span style="font-size: 12pt">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. </span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">Position Overview</b></div><div><span style="font-size: 12pt">The Pre-Screening Data Quality Manager will serve as an integral part of our organization, overseeing the data quality process for the Care Access Pre-screening Program. The individual will ensure that data collection quality checks are in place for each pre-screening program, queries are generated and resolved promptly, and quality trends are escalated to the Care Access central compliance team and staff managers when appropriate. Additionally, the Data Quality Manager may train and maintain a small team responsible for this process.&nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><i style="font-size: 13pt"><b>What You'll Be Working On</b></i></div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Develop the data quality plan in coordination with the central compliance team, site network leadership, and pre-screening event leadership.</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Work closely with site personnel to ensure the clinical data is accurate and complete.&nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Create training materials for the on-site data quality plan for the pre-screening training team.&nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Follow up with Site management to resolve queries promptly, ensuring quality data throughout the project.&nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Maintain quality dashboard and report findings and trends to sites and leadership.&nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Adjust the on-site data quality plan where necessary based on data trends and assist in facilitating training/re-training as needed.&nbsp;&nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Operationalize and implement the pre-screening data quality process for the pre-screening program.</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Regularly review and assess the process for potential improvements in efficiency and accuracy.&nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Maintain a call schedule for overseeing data quality at all sites active on a certain pre-screening project.</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Ensure all Care Access sites are aligned in their processes, company SOPs, and program-specific protocols regarding data quality checks, escalating where appropriate.&nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Ensure all processes are compliant with state-specific guidelines, legal, regulatory, and organizational policies.</div><div><span style="font-size: 9pt">&nbsp;</span></div><div><b style="font-size: 13pt">Physical and Travel Requirements</b></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role. </span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><i style="font-size: 13pt"><b>What You Bring</b></i></div><div><b style="font-size: 12pt">Knowledge, Skills, and Abilities:</b></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Leadership qualities </span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Successfully able to manage multiple sites/projects.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Project Management Experience</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Strong organizational skills: Able to prioritize, support, and follow through on assignments.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Thorough knowledge of company SOPs and Care Access Project Specific process flows/ expectations</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Excellent working knowledge of federal regulations, good clinical practices (GCP)</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">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.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Strong computer skills with demonstrated abilities using clinical trials databases and Microsoft systems.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ability to balance tasks with competing priorities.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Critical thinker and problem solver.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Maintain a positive attitude under pressure.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">High level of self-motivation and energy.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Must have a client-service mentality.</span></div><div><b style="font-size: 12pt">&nbsp;</b></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Certifications/Licenses, Education, and Experience:</b></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">4-5 years of Clinical Research experience, CCRC Preferred</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Regulatory submission and Investigator Site File experience</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Strong knowledge of GCP-ICH requirements and data collection in a research setting</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Proficient in research terminology and medical (basic) terminology</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Strength in communication, planning, and time management skills</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Strong People Skills</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Microsoft office and computer skills</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">Benefits (US Full-Time Employees Only)</b></div><div><span style="font-size: 13.5pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">PTO/vacation days, sick days, holidays. </span></div><div><span style="font-size: 13.5pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">100% paid medical, dental, and vision Insurance. 75% for dependents.</span></div><div><span style="font-size: 13.5pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">HSA plan</span></div><div><span style="font-size: 13.5pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Short-term disability, long-term disability, and life Insurance. </span></div><div><span style="font-size: 13.5pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Culture of growth and equality</span></div><div><span style="font-size: 13.5pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">401k retirement plan</span></div><div><b style="font-size: 13pt">&nbsp;</b></div><div><b style="font-size: 13pt">Diversity &amp; Inclusion</b></div><div><span style="font-size: 12pt">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. </span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">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</span></div><div><span style="font-size: 12pt">physicians and caring for patients.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">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.</span></div><div>&nbsp;</div><div><span style="font-size: 12pt">Care Access is unable to sponsor work visas at this time.</span></div><div><span style="font-size: 12pt">&nbsp;</span>&nbsp;</div><div><b style="font-size: 13pt">Employment Statement</b></div><div><span style="font-size: 11.5pt">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.</span></div>

Location: Remote, US

  

Employment Type: Full time - Temporary

  

Team: Supply Chain & Infrastructure

  

 ** **

 **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**

The Pre-Screening Data Quality Manager will serve as an integral part of our
organization, overseeing the data quality process for the Care Access Pre-
screening Program. The individual will ensure that data collection quality
checks are in place for each pre-screening program, queries are generated and
resolved promptly, and quality trends are escalated to the Care Access central
compliance team and staff managers when appropriate. Additionally, the Data
Quality Manager may train and maintain a small team responsible for this
process.



 _ **What You'll Be Working On**_

·         Develop the data quality plan in coordination with the central
compliance team, site network leadership, and pre-screening event leadership.

·         Work closely with site personnel to ensure the clinical data is
accurate and complete.

·         Create training materials for the on-site data quality plan for the
pre-screening training team.

·         Follow up with Site management to resolve queries promptly, ensuring
quality data throughout the project.

·         Maintain quality dashboard and report findings and trends to sites
and leadership.

·         Adjust the on-site data quality plan where necessary based on data
trends and assist in facilitating training/re-training as needed.  

·         Operationalize and implement the pre-screening data quality process
for the pre-screening program.

·         Regularly review and assess the process for potential improvements
in efficiency and accuracy.

·         Maintain a call schedule for overseeing data quality at all sites
active on a certain pre-screening project.

·         Ensure all Care Access sites are aligned in their processes, company
SOPs, and program-specific protocols regarding data quality checks, escalating
where appropriate.

·         Ensure all processes are compliant with state-specific guidelines,
legal, regulatory, and organizational policies.



 **Physical and Travel Requirements**

·         This is a remote position with less than 10% travel requirements.
Occasional planned travel may be required as part of the role.



 _ **What You Bring**_

 **Knowledge, Skills, and Abilities:**

·         Leadership qualities

·         Successfully able to manage multiple sites/projects.

·         Project Management Experience

·         Strong organizational skills: Able to prioritize, support, and
follow through on assignments.

·         Thorough knowledge of company SOPs and Care Access Project Specific
process flows/ expectations

·         Excellent working knowledge of federal regulations, good clinical
practices (GCP)

·         Communication Skills: Strong verbal and written communication skills
as evidenced 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 databases and Microsoft systems.

·         Ability to balance tasks with competing priorities.

·         Critical thinker and problem solver.

·         Maintain a positive attitude under pressure.

·         High level of self-motivation and energy.

·         Must have a client-service mentality.

 ** **



 **Certifications/Licenses, Education, and Experience:**

·         4-5 years of Clinical Research experience, CCRC Preferred

·         Regulatory submission and Investigator Site File experience

·         Strong knowledge of GCP-ICH requirements and data collection in a
research setting

·         Proficient in research terminology and medical (basic) terminology

·         Strength in communication, planning, and time management skills

·         Strong People Skills

·         Microsoft office and computer skills



 **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.

