<p>Location: Remote, US</p><br/><p>Employment Type: Full Time - Regular</p><br/><p>Team: Source Documents</p><br/><div><b style="font-size: 13pt">What We Do</b></div><div><span style="font-size: 12pt">Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. 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 the latest 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">As the Associate Director of the Source Department at Care Access Research, you will assume a leadership role in overseeing, motivating, and project managing a team of dedicated professionals. Your primary focus will be to ensure the efficient and compliant management of source documents across our clinical trials. And to implement e-source platforms across the Care Access Global site network. This critical role requires a combination of leadership, project management, and clinical research expertise to drive success.</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><b style="font-size: 12pt">Duties include but not limited to:</b></div><div><b style="font-size: 12pt">&nbsp;</b></div><div><b style="font-size: 12pt">Leadership and Motivation</b><span style="font-size: 12pt">: Lead and inspire the Source Department to achieve departmental and organizational goals. Foster a culture of collaboration, accountability, and continuous improvement within the team. Provide guidance, coaching, and mentorship to team members, supporting their professional development.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Project Management</b><span style="font-size: 12pt">: </span></div><div><span style="font-size: 12pt">Plan and implement e-Source platforms across the Care Access Global Site Network</span></div><div><span style="font-size: 12pt">Plan, initiate, and execute projects aligning with study-specific requirements.</span></div><div><span style="font-size: 12pt">Drive productivity, organize workloads, and plan resources to meet workload deliverables.</span></div><div><span style="font-size: 12pt">Implement a robust project management system to coordinate deliverables.</span></div><div><span style="font-size: 12pt">Track and supervise project progress, ensuring adequate resources, evaluating, and escalating risks, as necessary.</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><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Documentation Management:</b></div><div><span style="font-size: 12pt">Utilize protocols, case report forms, pharmacy manuals, and other essential documents to create comprehensive e-source builds/paper source templates tailored to study-specific needs from baseline templates.</span></div><div><span style="font-size: 12pt">Verify the accuracy and completeness of data fields and templates within the software.</span></div><div><span style="font-size: 12pt">Maintain a detailed audit trail of revisions.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Quality</b><span style="font-size: 12pt">: Ensure that source documents adhere to GCP (Good Clinical Practices) guidelines, 21 CFR Part 11 Compliance, and Care Access Research Internal Standard Operating Procedures (SOPs). Implement quality control processes to maintain the accuracy and completeness of source documents. Conduct regular reviews of templates to identify and address compliance issues.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Resource Management</b><span style="font-size: 12pt">: Allocate department resources effectively to support multiple clinical trials simultaneously. Assess staffing needs and participate in recruitment efforts, as necessary.</span></div><div><span style="font-size: 12pt">Manage department budgets and expenditures.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Stakeholder Engagement</b><span style="font-size: 12pt">: Collaborate with internal and external stakeholders, including site staff, sponsors, and regulatory authorities, to ensure seamless source document management.</span></div><div><span style="font-size: 12pt">Address inquiries and concerns promptly and professionally.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Reporting</b><span style="font-size: 12pt">: Generate comprehensive reports to present to leadership on productivity and improvement initiatives. Ensure deliverables for Sponsored projects meet expected quality standards.</span></div><div><span style="font-size: 12pt">Keep leadership fully informed of any projects that may impact the quality or timeliness of project delivery to customer satisfaction.</span></div><div><span style="font-size: 12pt">&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; </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">&nbsp;</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">Strong understanding of GCP guidelines and 21 CFR Part 11 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">Expert experience in e-Source systems (CRIO/Clinical Conductor e-source). </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">Prior experience in clinical research essential.</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">Proficiency in document management systems and software.</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">Expert experience in change management of systems</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">Excellent attention to detail and organizational skills.</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">Effective communication and interpersonal skills.</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">Ability to work collaboratively in a cross-functional team environment.</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">Proven leadership and team management skills</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">Strong project management expertise, including the ability to manage multiple projects simultaneously. </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">Excellent problem-solving skills.</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">Exceptional communication and interpersonal skills</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><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">Bachelor's degree in a relevant field (Life Sciences, Healthcare, or related discipline).</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">At least 5 years of experience in clinical research, with growing responsibilities.</span></div><div><span style="font-size: 12pt">&nbsp;</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;&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;&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;&nbsp; </span><span style="font-size: 12pt">HSA (Health Savings Account) plan</span></div><div><span style="font-size: 13.5pt">●</span><span style="font-size: 7pt">&nbsp;&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;&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;&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">&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 are uniting standard patient care with innovative 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 are 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 at this time.</span></div><div><span style="font-size: 12pt">&nbsp;</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>

Location: Remote, US

  

Employment Type: Full Time - Regular

  

Team: Source Documents

  

 **What We Do**

Care Access is delivering the future of medicine today! Care Access has a
revolutionary model that breaks down traditional barriers to clinical trials
that limit participation among physicians and patients to 3%. 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 the latest ideas to accelerate medicine, and seed a long-
term impact for generations.



 **Position Overview**

As the Associate Director of the Source Department at Care Access Research,
you will assume a leadership role in overseeing, motivating, and project
managing a team of dedicated professionals. Your primary focus will be to
ensure the efficient and compliant management of source documents across our
clinical trials. And to implement e-source platforms across the Care Access
Global site network. This critical role requires a combination of leadership,
project management, and clinical research expertise to drive success.



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

 **Duties include but not limited to:**

 ** **

 **Leadership and Motivation** : Lead and inspire the Source Department to
achieve departmental and organizational goals. Foster a culture of
collaboration, accountability, and continuous improvement within the team.
Provide guidance, coaching, and mentorship to team members, supporting their
professional development.



 **Project Management** :

Plan and implement e-Source platforms across the Care Access Global Site
Network

Plan, initiate, and execute projects aligning with study-specific
requirements.

Drive productivity, organize workloads, and plan resources to meet workload
deliverables.

Implement a robust project management system to coordinate deliverables.

Track and supervise project progress, ensuring adequate resources, evaluating,
and escalating risks, as necessary.











 **Documentation Management:**

Utilize protocols, case report forms, pharmacy manuals, and other essential
documents to create comprehensive e-source builds/paper source templates
tailored to study-specific needs from baseline templates.

Verify the accuracy and completeness of data fields and templates within the
software.

Maintain a detailed audit trail of revisions.



 **Quality** : Ensure that source documents adhere to GCP (Good Clinical
Practices) guidelines, 21 CFR Part 11 Compliance, and Care Access Research
Internal Standard Operating Procedures (SOPs). Implement quality control
processes to maintain the accuracy and completeness of source documents.
Conduct regular reviews of templates to identify and address compliance
issues.



 **Resource Management** : Allocate department resources effectively to
support multiple clinical trials simultaneously. Assess staffing needs and
participate in recruitment efforts, as necessary.

Manage department budgets and expenditures.



 **Stakeholder Engagement** : Collaborate with internal and external
stakeholders, including site staff, sponsors, and regulatory authorities, to
ensure seamless source document management.

Address inquiries and concerns promptly and professionally.



 **Reporting** : Generate comprehensive reports to present to leadership on
productivity and improvement initiatives. Ensure deliverables for Sponsored
projects meet expected quality standards.

Keep leadership fully informed of any projects that may impact the quality or
timeliness of project delivery to customer satisfaction.



 **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:**



·       Strong understanding of GCP guidelines and 21 CFR Part 11 Compliance.

·       Expert experience in e-Source systems (CRIO/Clinical Conductor
e-source).

·       Prior experience in clinical research essential.

·       Proficiency in document management systems and software.

·       Expert experience in change management of systems

·       Excellent attention to detail and organizational skills.

·       Effective communication and interpersonal skills.

·       Ability to work collaboratively in a cross-functional team
environment.

·       Proven leadership and team management skills

·       Strong project management expertise, including the ability to manage
multiple projects simultaneously.

·       Excellent problem-solving skills.

·       Exceptional communication and interpersonal skills



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

 ** **

·       Bachelor's degree in a relevant field (Life Sciences, Healthcare, or
related discipline).

·       At least 5 years of experience in clinical research, with growing
responsibilities.





 **Benefits (US Full-Time Employees Only)**

●      PTO/vacation days, sick days, holidays.

●      100% paid medical, dental, and vision Insurance. 75% for dependents.

●      HSA (Health Savings Account) 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 are
uniting standard patient care with innovative 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 are 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 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.

