<p>Location: Atlanta, GA</p><br/><p>Employment Type: Part Time - Regular</p><br/><p>Team: Principal Investigator</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">The Principal Investigator is responsible for ensuring that all research team members have appropriate education, training and qualifications to assume delegated study tests. Principal Investigator is responsible for ensuring that the conduct of the study is compliant with federal and industry guidance and regulations. Principal Investigators manage Phase 1 – Phase 4 studies, with demonstrated decision-making capabilities. They will also engage with the sponsor’s monitor to discuss findings and ensure timely correction and documentation of any identified issues.&nbsp;&nbsp; </span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">The administrative structure of investigational sites under the decentralized site model requires a nontraditional approach. The Principal Investigator will be responsible for the oversight of trial conduct at one or more facilities where participants are located. Since the facilities may not be in proximity, oversight will be provided in accordance with a well laid out Decentralized Clinical Trials Oversight Plan.&nbsp; </span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">This is a remote position for oversight for Sub Investigators, Research Coordinators, Laboratory Coordinators etc., is provided over email, phone, video conferencing etc. </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><b style="font-size: 12pt">Duties include but not limited to:</b></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Review the inclusion/exclusion criteria, endpoint criteria, and investigational article use with the internal research </span><a href="http://team.determine/" style="font-size: 12pt" class="postings-link">team.</a></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Determine whether inclusion/exclusion criteria apply to the study population.&nbsp; </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Maintain protocol compliance on all clinical trials/studies according to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP), local regulations, and study protocol. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Oversee IRB review of study and ensure written IRB approval is obtained before initiating the study or instituting any changes to the protocol as approved.&nbsp; </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Assess subject response to therapy, evaluate and address adverse experiences Meet regularly with the research team to discuss subject participation and protocol progress. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Meet with study assigned monitors at regular intervals. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Train Sub-Investigators and study staff members on protocol and protocol specific procedures. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Maintain essential documents and records necessary for conduction of study. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Train on and implement Care Access Standard Operating Procedures.&nbsp; </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Review sponsor provided safety reports. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Review and maintain accurate case report forms. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Sign off electronic case books as required by the study sponsor. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Provide clinical oversight and quality of the studies virtually.&nbsp; </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Ensure the medical well-being and safety of the study participants, through the safe performance and execution of the clinical trials/studies.&nbsp; </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Participate and engage in driving delivery of study targets, such as: participant recruitment, enrollment and retention. </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Perform other duties as assigned. </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: 7pt">&nbsp;</span><span style="font-size: 12pt">This is a remote positions 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><b style="font-size: 13pt">What You Bring</b></div><div>&nbsp;</div><div><b style="font-size: 12pt">Role Requirements:</b></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Prior research experience required&nbsp;&nbsp; </span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Possess a thorough understanding of the requirements of clinical protocols.</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; </span><span style="font-size: 12pt">Board Certification in any of the following areas: Internal Medicine, Cardiology, Gastroenterology, Dermatology, Endocrinology</span></div><div><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">MD/DO License in good standing. </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><span style="font-size: 12pt">&nbsp;</span></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.</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><br></div><div><span style="font-size: 16px">Care Access is unable to sponsor work visas at this time.&nbsp;</span></div><div>&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><div><br></div>

Location: Atlanta, GA

  

Employment Type: Part Time - Regular

  

Team: Principal Investigator

  

 **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**

The Principal Investigator is responsible for ensuring that all research team
members have appropriate education, training and qualifications to assume
delegated study tests. Principal Investigator is responsible for ensuring that
the conduct of the study is compliant with federal and industry guidance and
regulations. Principal Investigators manage Phase 1 – Phase 4 studies, with
demonstrated decision-making capabilities. They will also engage with the
sponsor’s monitor to discuss findings and ensure timely correction and
documentation of any identified issues.  



The administrative structure of investigational sites under the decentralized
site model requires a nontraditional approach. The Principal Investigator will
be responsible for the oversight of trial conduct at one or more facilities
where participants are located. Since the facilities may not be in proximity,
oversight will be provided in accordance with a well laid out Decentralized
Clinical Trials Oversight Plan.



This is a remote position for oversight for Sub Investigators, Research
Coordinators, Laboratory Coordinators etc., is provided over email, phone,
video conferencing etc.



 **What You'll Be Working On**

 **Duties include but not limited to:**

●   Review the inclusion/exclusion criteria, endpoint criteria, and
investigational article use with the internal research
[team.](http://team.determine/)

●   Determine whether inclusion/exclusion criteria apply to the study
population.

●   Maintain protocol compliance on all clinical trials/studies according to
the International Conference on Harmonization-Good Clinical Practice (ICH-
GCP), local regulations, and study protocol.

●   Oversee IRB review of study and ensure written IRB approval is obtained
before initiating the study or instituting any changes to the protocol as
approved.

●   Assess subject response to therapy, evaluate and address adverse
experiences Meet regularly with the research team to discuss subject
participation and protocol progress.

●   Meet with study assigned monitors at regular intervals.

●   Train Sub-Investigators and study staff members on protocol and protocol
specific procedures.

●   Provide medical support to sub-investigators and study staff for protocol-
related issues including protocol clarifications, inclusion/exclusion
determinations, and issues of patient safety and/or eligibility.

●   Maintain essential documents and records necessary for conduction of
study.

●   Train on and implement Care Access Standard Operating Procedures.

●   Review sponsor provided safety reports.

●   Review and maintain accurate case report forms.

●   Sign off electronic case books as required by the study sponsor.

●   Provide clinical oversight and quality of the studies virtually.

●   Ensure the medical well-being and safety of the study participants,
through the safe performance and execution of the clinical trials/studies.

●   Participate and engage in driving delivery of study targets, such as:
participant recruitment, enrollment and retention.

●   Perform other duties as assigned.



 **Physical and Travel Requirements**

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



 **What You Bring**



 **Role Requirements:**

●   Prior research experience required  

●   Possess a thorough understanding of the requirements of clinical
protocols.



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

●   Board Certification in any of the following areas: Internal Medicine,
Cardiology, Gastroenterology, Dermatology, Endocrinology

●   MD/DO License in good standing.



 **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.

  

