<p>Location: Remote, US</p><br/><p>Employment Type: Full Time - Regular</p><br/><p>Team: Operational Compliance</p><br/><div><b style="font-size: 16px;">What We Do</b><span style="font-size: 16px;">&nbsp;</span></div><div><span style="font-size: 16px;">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.&nbsp;</span></div><div><span style="font-size: 16px;">&nbsp;</span></div><div><b style="font-size: 16px;">Who We Are</b><span style="font-size: 16px;">&nbsp;</span></div><div><span style="font-size: 16px;">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.&nbsp;&nbsp;</span></div><div><span style="font-size: 16px;">&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 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.</span></div><div><br></div><div><b style="font-size: 18px;">What You'll Be Working On (Duties include but are not limited to):</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;">Complete operational compliance checks on clinical trial documents at sites. </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;">Maintain a quality and compliance role within operations, separate from operational quality control (QC) and routine operational activities.</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;">Provide quality focused support to the business so that regulatory compliance and commercial objectives are achieved.</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;">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.</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;">Maintain a CAPA owner listing and robust mechanisms for ensuring quality findings and CAPAs are addressed, implemented and effective. </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;">Escalate issues to management/QA. </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;">Support staff with process improvement and procedure definition and process mapping, where applicable.</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;">Facilitate and report root cause analysis to aid CAPA definition and process improvement, where applicable.</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;">Establish and maintain processes, procedures, and minimum expectations for operational compliance (OC), including, but not limited to:</span></div><div><span style="font-size: 12pt;">     o</span><span style="font-size: 7pt;">&nbsp;&nbsp; </span><span style="font-size: 12pt;">Oversight of quality control (QC), CAPA and process effectiveness </span></div><div><span style="font-size: 12pt;">     o</span><span style="font-size: 7pt;">&nbsp;&nbsp; </span><span style="font-size: 12pt;">Process for OC assessments, including scope/purpose/responsibilities.</span></div><div><span style="font-size: 12pt;">     o</span><span style="font-size: 7pt;">&nbsp;&nbsp; </span><span style="font-size: 12pt;">A risk-based approach</span></div><div><span style="font-size: 12pt;">     o</span><span style="font-size: 7pt;">&nbsp;&nbsp; </span><span style="font-size: 12pt;">Local OC activity schedule&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></div><div><span style="font-size: 12pt;">     o</span><span style="font-size: 7pt;">&nbsp;&nbsp; </span><span style="font-size: 12pt;">Process for OC output reporting, trending, distribution, follow up and CAPA definition. </span></div><div><span style="font-size: 12pt;">     o</span><span style="font-size: 7pt;">&nbsp;&nbsp; </span><span style="font-size: 12pt;">Identify operational quality performance measures, collate metrics on data generated within operational compliance and provide required metrics/RAG reports to management, as appropriate. </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 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.</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;">Support internal governance structures to facilitate quality, process improvement and compliance within operations.</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;">Support development and delivery of client governance/quality agreements in conjunction with QA and operational management.</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;">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.</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;">Maintain effective relationships internally and externally, for efficient and effective delivery of service. </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;">Comply with company quality framework, regulatory (GCP) legislation, guidelines, and international standards.</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;">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.</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;">Safeguard confidentiality of staff, participant and sponsor matters as required by regional Data Protection and Good Clinical Practice expectations.</span></div><div><br></div><h3>Physical and Travel Requirements </h3><br/><ul><li>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.</li></ul><br/><h3>What You Bring (Knowledge, Skills, and Abilities): </h3><br/><ul><li>Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.</li><li>In depth knowledge and understanding of the requirements, best practice, and organisation of a clinical research site.</li><li>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.</li><li>Experience in training other members of staff at all levels.</li><li>Excellent communication skills and the ability to manage upwards successfully.</li><li>Ability to work independently, with minimal supervision, and be confident to make local decisions and escalate accordingly.</li><li>Willingness to travel on a regular basis.</li><li>Exceptional customer services skills to both internal and external stakeholders.</li><li>An understanding and experience of working within a matrix management environment.</li><li>Experience of working within a highly regulated environment.</li><li>Personal skills including assertiveness, persistence, flexibility, highly organized and detail oriented.</li><li>research Experience in managing Stressful situations and managing controversial issues whilst firmly adhering to the principles of the regulations and guidelines.</li><li>Expertise in reviewing, revising, and writing Standard Operating Procedures.</li><li>Ability to manage projects / teams of significant scope and complexity, while meeting all deliverables and timelines</li></ul><br/><h3>Certifications/Licenses, Education, and Experience: </h3><br/><ul><li>5 years of relevant experience</li></ul><br/><h3>Benefits (US Full-Time Employees Only) </h3><br/><ul><li>PTO/vacation days, sick days, holidays.&nbsp;&nbsp;</li><li>100% paid medical, dental, and vision Insurance. 75% for dependents&nbsp;</li><li>HSA plan&nbsp;</li><li>Short-term disability, long-term disability, and life Insurance&nbsp;&nbsp;</li><li>Culture of growth and equality&nbsp;</li><li>401k retirement plan&nbsp;</li></ul><br/><div><b style="font-size: 16px;">Diversity &amp; Inclusion</b><span style="font-size: 16px;">&nbsp;</span></div><div><span style="font-size: 16px;"> &nbsp;</span></div><div><span style="font-size: 16px;">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. &nbsp;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.&nbsp;</span></div><div><br></div><div><span style="font-size: 16px;">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><span style="font-size: 16px;">&nbsp;</span></div><div><span style="font-size: 16px;">Care Access is unable to sponsor work visas at this time.&nbsp;</span></div><div><br></div><div><b style="font-size: 16px;">Employment Statement</b></div><div><span style="font-size: 16px;">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 - 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. 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.

