<p>Location: Remote, US</p><br/><p>Employment Type: Full Time - Regular</p><br/><p>Team: Global Study Operations</p><br/><div><b style="font-size: 12pt">Purpose:</b></div><div><span style="font-size: 12pt">The Manager, Regulatory, oversees the Regulatory team members and supports all aspects of regulatory efforts for the Care Access site model and is responsible for helping ensure compliance with regulations. This individual will stay abreast of regulations impacting the business according to Care Access SOPs, GCP, FDA/ICH, country-specific and all other applicable Regulatory Guidelines.</span></div><div><br></div><div><span style="font-size: 12pt">&nbsp;</span><b style="font-size: 12pt">DUTIES INCLUDE BUT ARE NOT LIMITED TO:</b></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Lead and oversee all aspects of the central regulatory team operations. Develop, improve, and make more robust the systems, repeatable processes, and workflows that support the successful function of central Regulatory in trials at Care Access.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Manage direct reports including Regulatory Specialist &amp; Regulatory Coordinators. This includes conducting interviews, making hiring recommendations, routine performance evaluations, performance improvement plans, overseeing scheduling, and department workflow.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Manage the successful onboarding and training of new hires to the Regulatory team.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Provide back-up support to Regulatory Associate role as needed including plan, prepare, and review submissions to applicable IRBs, such as:</span></div><div><span style="font-size: 12pt">o&nbsp;&nbsp; Initial submissions</span></div><div><span style="font-size: 12pt">o&nbsp;&nbsp; Continuing Reviews</span></div><div><span style="font-size: 12pt">o&nbsp;&nbsp; Study Closeout Reports</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Manage generic regulatory submissions including ICF, prescreening plans, and all marketing/recruitment materials requiring IRB approval</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Design creative solutions to stay within regulatory guidelines while the company creates new ways to run clinical trials.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assist in the development and maintenance of KPIs to measure department success</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Develop and maintain electronic regulatory platforms at Care Access.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Manage regulatory document/ISF quality through internal review (department QC) </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 knowledge of pertinent regulations and guidance </span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure quality is maintained in all investigator site files and regulatory workflows overall; Develop processes to verify compliance and best practice.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Support the submission of new CLIA waiver applications and maintain CLIA certification for sites or other required Site or PI level regulatory registrations certificates as needed.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Constantly strive to improve the department.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Lead by example and display a high level of integrity and professionalism.</span></div><div><span style="font-size: 12pt">Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive</span></div><div><br></div><div><span style="font-size: 12pt">&nbsp;</span><b style="font-size: 12pt">KNOWLEDGE, SKILLS, AND ABILITIES:</b></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent working knowledge of medical and research terminology</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Expert knowledge of federal research regulations and good clinical practices (GCP).</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to communicate and work effectively with a diverse team of professionals.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong computer skills with demonstrated abilities using CTMS and clinical trials database systems, electronic data capture, MS word, and excel.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to balance tasks with competing priorities.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Critical thinker and problem-solver.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Friendly, outgoing personality with the ability to maintain a positive attitude under pressure in fast-paced environment</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; High level of self-motivation, energy, initiative, and flexibility.</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Must have a client service mentality.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">EDUCATION:</b></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Bachelor’s Degree required in life sciences or equivalent education</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span><b style="font-size: 12pt">EXPERIENCE:</b></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; A minimum of 3 years of experience managing direct reports and teams</span></div><div><span style="font-size: 12pt">●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; A minimum of 3 years of experience in regulatory</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Certifications:</b></div><div><span style="font-size: 12pt">●&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp; CCRC or CCRP preferred</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><br></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: Global Study Operations

  

 **Purpose:**

The Manager, Regulatory, oversees the Regulatory team members and supports all
aspects of regulatory efforts for the Care Access site model and is
responsible for helping ensure compliance with regulations. This individual
will stay abreast of regulations impacting the business according to Care
Access SOPs, GCP, FDA/ICH, country-specific and all other applicable
Regulatory Guidelines.

  

  **DUTIES INCLUDE BUT ARE NOT LIMITED TO:**

●       Lead and oversee all aspects of the central regulatory team
operations. Develop, improve, and make more robust the systems, repeatable
processes, and workflows that support the successful function of central
Regulatory in trials at Care Access.

●       Manage direct reports including Regulatory Specialist & Regulatory
Coordinators. This includes conducting interviews, making hiring
recommendations, routine performance evaluations, performance improvement
plans, overseeing scheduling, and department workflow.

●       Manage the successful onboarding and training of new hires to the
Regulatory team.

●       Provide back-up support to Regulatory Associate role as needed
including plan, prepare, and review submissions to applicable IRBs, such as:

o   Initial submissions

o   Continuing Reviews

o   Study Closeout Reports

●       Manage generic regulatory submissions including ICF, prescreening
plans, and all marketing/recruitment materials requiring IRB approval

●       Design creative solutions to stay within regulatory guidelines while
the company creates new ways to run clinical trials.

●       Assist in the development and maintenance of KPIs to measure
department success

●       Develop and maintain electronic regulatory platforms at Care Access.

●       Manage regulatory document/ISF quality through internal review
(department QC)

●       Maintain knowledge of pertinent regulations and guidance

●       Ensure quality is maintained in all investigator site files and
regulatory workflows overall; Develop processes to verify compliance and best
practice.

●       Support the submission of new CLIA waiver applications and maintain
CLIA certification for sites or other required Site or PI level regulatory
registrations certificates as needed.

●       Constantly strive to improve the department.

●       Lead by example and display a high level of integrity and
professionalism.

Perform other duties as assigned. The duties and responsibilities listed above
are representative of the nature and level of work assigned and are not
necessarily all-inclusive

  

  **KNOWLEDGE, SKILLS, AND ABILITIES:**

●       Excellent working knowledge of medical and research terminology

●       Expert knowledge of federal research regulations and good clinical
practices (GCP).

●       Ability to communicate and work effectively with a diverse team of
professionals.

●       Strong organizational skills: Able to prioritize, delegate, direct,
support, assign and evaluate others work and follow through on assignments

●      Team Collaboration Skills: Work effectively and collaboratively with
other team members to accomplish mutual goals. Bring positive and supportive
attitude to achieving these goals.

●       Strong computer skills with demonstrated abilities using CTMS and
clinical trials database systems, electronic data capture, MS word, and excel.

●       Ability to balance tasks with competing priorities.

●       Critical thinker and problem-solver.

●       Curiosity and passion to learn, innovate, able to take thoughtful
risks and get things done.

●       Friendly, outgoing personality with the ability to maintain a positive
attitude under pressure in fast-paced environment

●       High level of self-motivation, energy, initiative, and flexibility.

●       Must have a client service mentality.



 **EDUCATION:**

●       Bachelor’s Degree required in life sciences or equivalent education



  **EXPERIENCE:**

●       A minimum of 3 years of experience managing direct reports and teams

●       A minimum of 3 years of experience in regulatory



 **Certifications:**

●         CCRC or CCRP preferred

 **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.

