<p>Location: Remote, US</p><br/><p>Employment Type: Full-time Employment</p><br/><p>Team: Management</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 Region Manager assumes overall responsibility for the management of up to sites in an assigned geography. This individual’s responsibility spans the entire functionality of the sites to include personnel management, site profitability and the successful conduct of all studies while providing a high-quality point of intersection for staff, study subjects, CROs and sponsors. The Senior Regional Manager provides leadership and oversight of site operations according to CARE SOPs, GCP and FDA/ICH Guidelines.</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">The Senior Region Manager, Research Empowered Communities (REC), will be responsible for:</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 12pt">Overall ownership of Clinical Operations at REC sites:</b><span style="font-size: 12pt"> Including P&amp;L ownership of REC sites, Enhanced stakeholder management of Principal Investigators, relevant REC-specific external and internal stakeholders, inclusive of Clinical Research Coordinators at the site. As needed direct Liaison to Community contacts.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 12pt">Leading and proactively managing a team:</b><span style="font-size: 12pt"> Set goals and objectives for the team in alignment with KPIs. Manage team performance, ensuring continuous feedback, support, and coaching are provided. In partnership with the Director of Site Conduct, interview and hire new staff members as needed. Liaise with the Training Manager to train and onboard new team members and ensure all annual training and documentation is up to date.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 12pt">Ensure active management of studies and site workload and maintenance:</b><span style="font-size: 12pt"> In partnership with Investigator(s), evaluate and determine feasibility of upcoming opportunities/protocols. Liaise with appropriate stakeholders to ensure site, coordinator, study, and sponsor needs are met in terms of staff coverage, vendor support, site maintenance, and timely study start-up and activation of new trials in line with established and regulatory guidelines/requirements as applicable. Ensure QC/QA of key materials and reports, and work with the QA team and site teams to address any issues that may arise, including coordinating the creation of CAPA plans as required for complete and timely execution. Responsible for planned revenue generation of each site within the assigned region. Review protocols to identify needed outsourcing procedures and plan for and communicate any upcoming staffing needs to the Director of Site Conduct.</span></div><div><span style="font-size: 12pt">&nbsp;</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 expected and are not necessarily all-inclusive.</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">Travel requirements will be as needed, up to 50% of the time nationwide. Frequency and length of travel may depend on site level activities (e.g., Site Evaluation Visits, etc.)</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">No significant lifting.</span></div><div><b style="font-size: 12pt">&nbsp;</b></div><div><b style="font-size: 13pt">What You Bring</b></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 12pt">Knowledge, Skills and Abilities:</b></div><div><span style="font-size: 12pt">o</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Excellent working knowledge of medical and research terminology. Excellent working knowledge of federal regulations, 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.</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 12pt">Communication skills: </b></div><div><span style="font-size: 12pt">o</span><span style="font-size: 7pt">&nbsp;&nbsp; </span><span style="font-size: 12pt">Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors. 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 clinical trials database, IVR 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. High level of self-motivation, energy and possess a high degree of urgency. Ability to work independently in a fast-paced environment with minimal supervision. Ability to adapt to changes in responsibilities and workloads. Must have a client service mentality.</span></div><div><b style="font-size: 12pt">&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 preferred, or equivalent combination of education, training and experience</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">A minimum of 1 year of relevant management experience</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">A minimum of 3 years prior Clinical Research Coordinator experience</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">1 year of experience as a Care Access Research Clinical Research Coordinator Preferred.</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">RN or LPN preferred.</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">Research Professional Certification- CCRP/CCRC preferred.</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: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">PTO/vacation days, sick days, holidays. </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">100% paid medical, dental, and vision Insurance. 75% for dependents.</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">HSA plan</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">Short-term disability, long-term disability, and life Insurance. </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">Culture of growth and equality</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">401k retirement plan</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">&nbsp;</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>&nbsp;</div><div><span style="font-size: 12pt">Care Access is unable to sponsor work visas at this time.</span></div>

Location: Remote, US

  

Employment Type: Full-time Employment

  

Team: Management

  

 **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 Region Manager assumes overall responsibility for the management of up to
sites in an assigned geography. This individual’s responsibility spans the
entire functionality of the sites to include personnel management, site
profitability and the successful conduct of all studies while providing a
high-quality point of intersection for staff, study subjects, CROs and
sponsors. The Senior Regional Manager provides leadership and oversight of
site operations according to CARE SOPs, GCP and FDA/ICH Guidelines.



 **What You'll Be Working On**

 **Duties include but not limited to:**

The Senior Region Manager, Research Empowered Communities (REC), will be
responsible for:

·       **Overall ownership of Clinical Operations at REC sites:** Including
P&L ownership of REC sites, Enhanced stakeholder management of Principal
Investigators, relevant REC-specific external and internal stakeholders,
inclusive of Clinical Research Coordinators at the site. As needed direct
Liaison to Community contacts.

·       **Leading and proactively managing a team:** Set goals and objectives
for the team in alignment with KPIs. Manage team performance, ensuring
continuous feedback, support, and coaching are provided. In partnership with
the Director of Site Conduct, interview and hire new staff members as needed.
Liaise with the Training Manager to train and onboard new team members and
ensure all annual training and documentation is up to date.

·       **Ensure active management of studies and site workload and
maintenance:** In partnership with Investigator(s), evaluate and determine
feasibility of upcoming opportunities/protocols. Liaise with appropriate
stakeholders to ensure site, coordinator, study, and sponsor needs are met in
terms of staff coverage, vendor support, site maintenance, and timely study
start-up and activation of new trials in line with established and regulatory
guidelines/requirements as applicable. Ensure QC/QA of key materials and
reports, and work with the QA team and site teams to address any issues that
may arise, including coordinating the creation of CAPA plans as required for
complete and timely execution. Responsible for planned revenue generation of
each site within the assigned region. Review protocols to identify needed
outsourcing procedures and plan for and communicate any upcoming staffing
needs to the Director of Site Conduct.



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

 **Physical and Travel Requirements**

·       Travel requirements will be as needed, up to 50% of the time
nationwide. Frequency and length of travel may depend on site level activities
(e.g., Site Evaluation Visits, etc.)

·       No significant lifting.

 ** **

 **What You Bring**

·       **Knowledge, Skills and Abilities:**

o   Excellent working knowledge of medical and research terminology. Excellent
working knowledge of federal regulations, 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.

·       **Communication skills:**

o   Strong verbal and written communication skills as evidenced by positive
interactions with coworkers, management, clients and vendors. 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 clinical trials database, IVR 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. High level of
self-motivation, energy and possess a high degree of urgency. Ability to work
independently in a fast-paced environment with minimal supervision. Ability to
adapt to changes in responsibilities and workloads. Must have a client service
mentality.

 ** **

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

·       Bachelor’s Degree preferred, or equivalent combination of education,
training and experience

·       A minimum of 1 year of relevant management experience

·       A minimum of 3 years prior Clinical Research Coordinator experience

·       1 year of experience as a Care Access Research Clinical Research
Coordinator Preferred.

·       RN or LPN preferred.

·       Research Professional Certification- CCRP/CCRC preferred.



 **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.

