<p>Location: Warsaw</p><br/><p>Employment Type: Full-time Employment</p><br/><p>Team: Global Study Operations</p><br/><div><span style="font-size: 16px">&nbsp;</span><b style="font-size: 16px">What We Do</b></div><div><span style="font-size: 16px">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><br></div><div><b style="font-size: 16px">Who We Are</b></div><div><span style="font-size: 16px">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><br></div><div><b style="font-size: 16px">Position Overview</b></div><div><span style="font-size: 16px">Care Access Study Start Up Managers play a critical role in facilitating the start-up activities needed to select and activate studies at sites within Care Access. This role supports the selection and start-up process for our sites by leading cross-functional groups across the global organization to complete successful pre-site visits and accelerate site activation. This role will follow the Care Access study start-up processes in accordance with industry regulations, Care Access SOPs, and study-specific requirements.</span></div><div><span style="font-size: 16px">&nbsp;</span></div><div><span style="font-size: 16px">&nbsp;</span><b style="font-size: 16px">What You'll Be Working On</b></div><div><b style="font-size: 16px">Duties include but not limited to:</b></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Lead the process of global study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent </span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Oversee the execution of Site Activation, site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan.</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Provide overall guidance and oversight of programs during initial start-up phase as an integral member of the study start-up team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Identify regulatory complexity and challenges and offer creative and practical solutions</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Collect and interpret information from the Protocol &amp; Site Feasibility team to help prepare the sites and site staff that have been chosen for site evaluation visits </span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Support sites through their evaluation and begin start-up activities upon selection</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Review study information and understand start-up timelines, requirements, key contacts, and performance expectations</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Track and report on forecasted and actual SSU submission and approval timelines</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Work closely with the staff onsite to help address their remaining questions about the study</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Partner with other Care Access teams to initiate other Study related processes at the appropriate SSU milestone (e.g. capacity planning, systems build requests, etc)</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure that any and all information gained during the start-up process is completely transitioned to sites, as required</span></div><div><br></div><div><b style="font-size: 16px">Physical and Travel Requirements</b></div><div><span style="font-size: 16px">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><br></div><div><b style="font-size: 16px">What You Bring</b></div><div><b style="font-size: 16px">Knowledge, Skills, and Abilities:</b></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Expert knowledge of general clinical research processes and Good Clinical Practice</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Expert knowledge of EU CTR regulatory requirements &amp; submission guidelines</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent written and verbal communication skills including good command of English &amp; Polish language.</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; High level of professionalism and confidentiality required</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent interpersonal skills</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to manage against tight timelines and competing priorities</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong judgment and ability to make evidence based decisions</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Proficient with Microsoft Office Suite </span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experience working with Salesforce and CRIO</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to work collaboratively across departments</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent project and process management skills; ability to prioritize in a fast-paced work environment, pivot quickly based on changing business needs, and manage time appropriately</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to build relationships effectively in a geographically dispersed, largely remote environment</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to independently coordinate and manage new processes</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to establish and maintain effective working relationships with coworkers, managers and clients</span></div><div><b style="font-size: 16px">Certifications/Licenses, Education, and Experience:</b></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Minimum 5+ years clinical research experience with at least 1+ years of relevant experience completing study start-up activities at a site</span></div><div><span style="font-size: 16px">·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Bachelor’s degree in life sciences or equivalent is preferred (6-10 years of experience in lieu of degree)</span></div><div><br></div><div><b style="font-size: 16px">Diversity &amp; Inclusion</b></div><div><span style="font-size: 16px">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. &nbsp;</span></div><div><span style="font-size: 16px">&nbsp;</span></div><div><span style="font-size: 16px">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: 16px">physicians and caring for patients.</span></div><div><span style="font-size: 16px">&nbsp;</span></div><div><span style="font-size: 16px">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><span style="font-size: 16px">&nbsp;</span></div><div><span style="font-size: 16px">Care Access is unable to sponsor work visas at this time.</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><div><span style="font-size: 12pt">&nbsp;</span></div>

Location: Warsaw

  

Employment Type: Full-time Employment

  

Team: Global Study Operations

  

  **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 Study Start Up Managers play a critical role in facilitating the
start-up activities needed to select and activate studies at sites within Care
Access. This role supports the selection and start-up process for our sites by
leading cross-functional groups across the global organization to complete
successful pre-site visits and accelerate site activation. This role will
follow the Care Access study start-up processes in accordance with industry
regulations, Care Access SOPs, and study-specific requirements.



  **What You'll Be Working On**

 **Duties include but not limited to:**

·         Lead the process of global study start-up to support site
evaluation/selection visits on each new study and help get selected sites
successfully activated and ready to consent

·         Oversee the execution of Site Activation, site activation strategy,
adhering to project timelines. Develop, implement, and maintain the Management
Plan according to the Scope of Work and Project Plan.

·         Provide overall guidance and oversight of programs during initial
start-up phase as an integral member of the study start-up team. Determine
regulatory strategy/expectations and parameters for submissions and all
necessary authorizations.

·         Identify regulatory complexity and challenges and offer creative and
practical solutions

·         Collect and interpret information from the Protocol & Site
Feasibility team to help prepare the sites and site staff that have been
chosen for site evaluation visits

·         Support sites through their evaluation and begin start-up activities
upon selection

·         Review study information and understand start-up timelines,
requirements, key contacts, and performance expectations

·         Track and report on forecasted and actual SSU submission and
approval timelines

·         Liaise with key stakeholders across the global organization to
communicate needs and establish start-up timelines

·         Work closely with the staff onsite to help address their remaining
questions about the study

·         Support the site through the Site Evaluation Visit, Site Initiation
Visit, and greenlight to consent

·         Partner with other Care Access teams to initiate other Study related
processes at the appropriate SSU milestone (e.g. capacity planning, systems
build requests, etc)

·         Ensure that any and all information gained during the start-up
process is completely transitioned to sites, as required

  

 **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:**

·         Expert knowledge of general clinical research processes and Good
Clinical Practice

·         Expert knowledge of EU CTR regulatory requirements & submission
guidelines

·         Excellent written and verbal communication skills including good
command of English & Polish language.

·         High level of professionalism and confidentiality required

·         Excellent interpersonal skills

·         Ability to manage against tight timelines and competing priorities

·         Strong judgment and ability to make evidence based decisions

·         Proficient with Microsoft Office Suite

·         Experience working with Salesforce and CRIO

·         Ability to work collaboratively across departments

·         Excellent project and process management skills; ability to
prioritize in a fast-paced work environment, pivot quickly based on changing
business needs, and manage time appropriately

·         Ability to build relationships effectively in a geographically
dispersed, largely remote environment

·         Ability to independently coordinate and manage new processes

·         Ability to establish and maintain effective working relationships
with coworkers, managers and clients

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

·         Minimum 5+ years clinical research experience with at least 1+ years
of relevant experience completing study start-up activities at a site

·         Bachelor’s degree in life sciences or equivalent is preferred (6-10
years of experience in lieu of degree)

  

 **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.



