<p>Location: Warsaw</p><br/><p>Employment Type: Full Time - Regular</p><br/><p>Team: Operational Compliance</p><br/><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. 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;">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.</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b><i style="font-size: 13pt;">What You'll Be Working On</i></b></div><div><b style="font-size: 12pt;">Duties include but not limited to:</b></div><div><b style="font-size: 12pt;">&nbsp;</b></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Oversee the accuracy and quality of data for research projects within a designated research site. </span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Develop, maintain and produce dashboard metrics for site recruitment, participant statuses and operational quality metrics for research projects within a designated research site. </span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Oversee the Data and Quality Processes within a designated site, which include PI Oversight, Delegation Log checks, and SAE reporting tracking. </span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Oversee the implementation of best practices within a designated site to pre-empt quality issues. </span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">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. </span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Collaborate with the Operational Compliance Team for the facilitation and participation of Root Cause Analysis. </span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">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. </span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Ensure designated site staff are compliant with regulatory, client and or Sponsor requirements and or expectations</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 13pt;">Physical and Travel Requirements</b></div><div><span style="font-size: 12pt;">This is an on-site position with regional commute requirements. Regularly planned travel within region will be required as part of the role. Overnight travel will be minimal (&lt;10%).&nbsp;</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b><i style="font-size: 13pt;">What You Bring</i></b></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; </span><span style="font-size: 12pt;">Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.</span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">knowledge and understanding of the industry requirements, best practice, and organization of a clinical research site.</span></div><div><span style="font-size: 12pt;">·</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Minimum of 3 years industry experience and have had exposure to internal audits as well as Regulatory inspections.</span></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; </span><span style="font-size: 12pt;">Minimum of 3 years of industry experience </span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b style="font-size: 13pt;">Benefits </b></div><div><span style="font-size: 15px;">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; PTO/vacation days, sick days, holidays.</span></div><div><span style="font-size: 15px;">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; LuxMed</span></div><div><span style="font-size: 15px;">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; PPK Plan</span></div><div><span style="font-size: 15px;">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Life Insurance</span></div><div><span style="font-size: 15px;">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Health &amp; Wellness Allowance</span></div><div><span style="font-size: 15px;">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Culture of growth and equality</span>&nbsp;</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><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><div><span style="font-size: 12pt;">&nbsp;</span></div>

Location: Warsaw

  

Employment Type: Full Time - Regular

  

Team: Operational Compliance

  

 **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. 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 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 an on-site position with regional commute requirements. Regularly
planned travel within region will be required as part of the role. Overnight
travel will be minimal (<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**

●      PTO/vacation days, sick days, holidays.

●      LuxMed

●      PPK Plan

●      Life Insurance

●      Health & Wellness Allowance

●      Culture of growth and equality

 ** **

 **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.



