<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 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">Care Access Research is currently looking to hire a full time, remote, Source Document Specialist. The Source Document Specialist will be responsible for creating, maintaining, and controlling accurate versions of source documents (eSource or paper) for each clinical trial to substantiate trial activities.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">What You'll Be Working On</b></div><div><span style="font-size: 12pt">Duties include but not limited to:</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">All source documents will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to Care Access Research internal SOP.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Initial creation of e-Source with use of all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided templates/worksheets, or reference manuals) to design source documents that are accurate and complete and to ensure that the source document is equipped to record all the required data for a clinical trial.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Create paper source templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Review draft source and ensure it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Coordinate initial source review and update process.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Maintain version control of all source documents.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Update current source as needed per protocol amendments.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">File, maintain, distribute, organize, and archive source for each clinical trial.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Manage daily communication with Site staff and other internal departments</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">Remote role, with minimal travel requirements</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">What You Bring</b></div><div><span style="font-size: 12pt">Role Requirements:</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Experience as a Clinical Research Coordinator with diverse and complex clinical trials preferred.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Skilled and proficient with e-Source build and design (e.g. CRIO/Clinical Conductor)</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Skilled in creation and revision of paper source templates. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ability to interpret clinical trial protocol and determine how to design complete and accurate source documents.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Self-motivated, task oriented, detailed person who can work independently prioritizing responsibilities and adhering to project deadlines.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ability to create source documents in Excel.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Willing to learn computerized programs used in creating eSource.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Good verbal and written communication skills, especially for the remote work environment, including editing, proofreading, and grammar skills.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Highly organized.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">IT Skills including Word, Email and Direct Messaging, digital document maintenance, and expert level in Excel.</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ability to work well within a team.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">&nbsp;</b></div><div><b style="font-size: 13pt">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">Bachelor's degree in a relevant field (Life Sciences, Healthcare, or related discipline), or relevant experience. </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 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><span style="font-size: 12pt">&nbsp;</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">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</span></div><div><span style="font-size: 12pt">physicians and caring for patients. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled.</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></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 new ideas to accelerate medicine, and seed a long-term
impact for generations.



 **Position Overview**

Care Access Research is currently looking to hire a full time, remote, Source
Document Specialist. The Source Document Specialist will be responsible for
creating, maintaining, and controlling accurate versions of source documents
(eSource or paper) for each clinical trial to substantiate trial activities.



 **What You'll Be Working On**

Duties include but not limited to:

●      All source documents will follow GCP Guidelines and 21 CFR Part 11
Compliance in addition to Care Access Research internal SOP.

●      Initial creation of e-Source with use of all available protocol
specific documents (i.e., current IRB approved protocol, blank or annotated
CRF, Sponsor provided templates/worksheets, or reference manuals) to design
source documents that are accurate and complete and to ensure that the source
document is equipped to record all the required data for a clinical trial.

●      Create paper source templates, worksheets, supplemental source for
visits based on detailed review of protocol-defined exams, tests, evaluations,
and assessments.

●      Review draft source and ensure it is accurate and complete and to
ensure that the source document is equipped to record all the required data
for the trial.

●      Coordinate initial source review and update process.

●      Maintain version control of all source documents.

●      Update current source as needed per protocol amendments.

●      File, maintain, distribute, organize, and archive source for each
clinical trial.

●      Manage daily communication with Site staff and other internal
departments



 **Physical and Travel Requirements**

·       Remote role, with minimal travel requirements



 **What You Bring**

Role Requirements:

●      Experience as a Clinical Research Coordinator with diverse and complex
clinical trials preferred.

●      Skilled and proficient with e-Source build and design (e.g.
CRIO/Clinical Conductor)

●      Skilled in creation and revision of paper source templates.

●      Ability to interpret clinical trial protocol and determine how to
design complete and accurate source documents.

●      Self-motivated, task oriented, detailed person who can work
independently prioritizing responsibilities and adhering to project deadlines.

●      Ability to create source documents in Excel.

●      Willing to learn computerized programs used in creating eSource.

●      Good verbal and written communication skills, especially for the remote
work environment, including editing, proofreading, and grammar skills.

●      Highly organized.

●      IT Skills including Word, Email and Direct Messaging, digital document
maintenance, and expert level in Excel.

●      Ability to work well within a team.



 ** **

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

·       Bachelor's degree in a relevant field (Life Sciences, Healthcare, or
related discipline), or 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. Our team of experts is paving the way to
take this vision forward through innovation and a unique technology-enabled.



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.

