<p>Location: Remote, US</p><br/><p>Employment Type: Full-time Employment</p><br/><p>Team: Clinical Delivery</p><br/><div><b>What We Do</b>&nbsp;</div><div>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.&nbsp;</div><div>&nbsp;&nbsp;</div><div><b>Who We Are</b>&nbsp;</div><div>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.&nbsp;&nbsp;</div><div>&nbsp;&nbsp;</div><div><b>Position Overview</b>&nbsp;</div><div>This role requires an active RN license. Central Clinical Services enables decentralized and hybrid clinical trials by providing staff who virtually support patients and sites. The Central Study Coordinator (CSC) position combines clinical research and project management skills&nbsp;into a singular role that delivers a strong customer experience for both patients and sites. The CSC acts as a virtual extension of the research site and supports one to four sites concurrently across one or more studies. The CSC is accountable for study delivery at the patient level, including screening, consenting, and conducting protocol mandated study visits, and is expected to coordinate daily work using patient centric practices and a quality-first approach. The CSC also serves as a project manager for their assigned studies with their assigned PIs, helping their sites to stay on top of study deliverables in line with sponsor and CRO expectations. As such, this role will also manage monitoring visits, data management, and query resolution for their assigned sites, and ensure ongoing inspection readiness. This is a mid-to-senior level individual contributor role with the expectation that the CSC has strong working knowledge of and experience in the clinical research industry. &nbsp;</div><div>&nbsp;&nbsp;&nbsp;&nbsp;</div><div><b>What You'll Be Working On</b>&nbsp;</div><div><b>Duties include but are not limited to:</b>&nbsp;</div><div>&nbsp;</div><div><b>CSC I:</b>&nbsp;</div><div>&nbsp;</div><div>Licensed RN in the state of Pennsylvania </div><div>Manage study work for each assigned site as delegated by the PI,      collaborating with multiple sites and site teams concurrently to deliver      the highest quality work with each participant for each site&nbsp;</div><div>Build strong rapport with sites, participants, CRAs, and sponsor      contacts&nbsp;</div><div>Host regular calls with each assigned PI and present on key      elements of the study within CSC scope, which may include a review of new      referrals, participants in screening, participants in treatment, data and      query progress and issues, upcoming monitoring visits, etc. &nbsp;</div><div>Prepare meeting agendas and circulate meeting minutes, follow-up      on action items for self and teammates&nbsp;</div><div>Make decisions that optimize the experience within the study for      the participant, PI, and other site staff&nbsp;</div><div>Facilitate communication between study site, CRA, and sponsor&nbsp;</div><div>Pre-screen and educate potential study participants on the study.      Manage participant referral portals and study specific applications in      real time in accordance with GCP &nbsp;</div><div>Perform the Informed Consent process with study participants      virtually using e-consent technology. Review all elements of the ICF with      the participant and assess their understanding to ensure the protection of      human participants in clinical research. Complete signatures using the      e-consent platform and register participants in IWRS&nbsp;</div><div>Schedule, prepare for, and facilitate participant visits in      accordance with the study protocol. This may include overseeing the      required scheduling, logistics, technology requirements, and communication      applications for participants, central raters, investigators, and other      study-related entities such as MRI centers and infusion centers&nbsp;</div><div>Maintain all study documentation in accordance with ALCOA-C &nbsp;</div><div>Enter data and resolve queries in EDC and other portals within      appropriate time window defined by the study&nbsp;</div><div>Perform quality checks for self and others to ensure overall data      integrity&nbsp;</div><div>Complete ongoing trainings and adhere to system access guidelines&nbsp;</div><div>Correctly identify, document, and report AEs and SAEs&nbsp;</div><div>Analyze and understand study protocols &nbsp;</div><div>Support site compliance with subject safety reporting&nbsp;</div><div>Ensure all study trackers and systems are up to date daily&nbsp;</div><div>Additional duties and responsibilities may be assigned as needed&nbsp;</div><div>&nbsp;&nbsp;</div><div><b>CSC II includes all the above plus the following:</b>&nbsp;</div><div>&nbsp;</div><div>Manage and deliver special projects for the team&nbsp;</div><div>Support and guide others on understanding of the protocol and GCP&nbsp;</div><div>Train, mentor, and coach other CSCs on study conduct and CSC      processes&nbsp;</div><div>Identify solutions to issues with study processes, proactively      identify and implement process improvements&nbsp;</div><div>Autonomously evaluate competing activities and decide on      priorities based on guidance provided by manager and study team&nbsp;</div><div>&nbsp;</div><div><b>&nbsp;</b></div><div><br></div><div><b> Physical and Travel Requirements</b>&nbsp;</div><div>This is a remote position with less than 10% travel requirements.      Occasional planned travel may be required as part of the role.&nbsp;</div><div>&nbsp;&nbsp;</div><div><b>What You Bring</b>&nbsp;</div><div><b>Knowledge, Skills, and Abilities:</b>&nbsp;</div><div>&nbsp;</div><div><b>CSC I:</b>&nbsp;</div><div>Able to navigate and troubleshoot a wide variety of technologies      used for clinical research including recruitment platforms, IWRS, EDC, and      other clinical trial software, and able to work across multiple platforms      at the same time&nbsp;</div><div>Proficient with Microsoft Office applications (Word, Outlook,      Teams, and Excel)&nbsp;</div><div>Demonstrate professionalism in all situations and work effectively      with a diverse group of individuals &nbsp;</div><div>Understand when issues require escalation&nbsp;</div><div>Strong communication customer service abilities&nbsp;</div><div>Proficient in research terminology and basic medical terminology&nbsp;</div><div>Understand the overall clinical development paradigm and excellent      working knowledge of government regulations, GCP, and ALCOA-C&nbsp;</div><div>Strong organization and time management skills&nbsp;</div><div>High attention to detail&nbsp;</div><div>Ability to work in a fast-paced environment&nbsp;</div><div>Critical thinker and problem solver&nbsp;</div><div>Ability to work effectively in a remote environment&nbsp;</div><div>Proper home office set-up including a private space for      participant communication and high-speed internet (at minimum: 100MB up      and 15 MB down, 5 GHz router)&nbsp;</div><div>&nbsp;<b>&nbsp;</b>&nbsp;</div><div><b>CSC II includes all the above plus the following:</b>&nbsp;</div><div>Advanced communication skills both verbally and in writing&nbsp;</div><div>Able to speak to all levels of an organization &nbsp;</div><div>People mentoring abilities&nbsp;</div><div>&nbsp;</div><div><b>Certifications/Licenses, Education, and Experience:</b>&nbsp;</div><div>&nbsp;</div><div><b>CSC I:</b>&nbsp;</div><div>At least 3 years of relevant clinical research experience&nbsp;</div><div>CCRC preferred&nbsp;</div><div>Fluency in Spanish is a bonus&nbsp;</div><div>Active Pennsylvania RN licensure </div><div>&nbsp;&nbsp;</div><div><b>&nbsp;</b></div><div><b>&nbsp;</b></div><div><b>CSC II:</b>&nbsp;</div><div>At least 4&nbsp;years of relevant clinical research experience,      and at least 1 year as a high performing CSC I&nbsp;</div><div>CCRC preferred&nbsp;</div><div>Fluency in Spanish is a bonus&nbsp;</div><div>Active Pennsylvania RN licensure </div><div><b>&nbsp;</b></div><div><b>&nbsp;</b></div><div><b>Benefits (US Full-Time Employees Only)</b>&nbsp;</div><div>PTO/vacation days, sick days, holidays.&nbsp;&nbsp;</div><div>100% paid medical, dental, and vision Insurance. 75% for      dependents&nbsp;</div><div>HSA plan&nbsp;</div><div>Short-term disability, long-term disability, and life      Insurance&nbsp;&nbsp;</div><div>Culture of growth and equality&nbsp;</div><div>401k retirement plan&nbsp;</div><div>&nbsp;</div><div><b>&nbsp;</b></div><div><b>Diversity &amp; Inclusion</b>&nbsp;</div><div> &nbsp;</div><div>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;</div><div>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.&nbsp;</div><div> &nbsp;</div><div>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.&nbsp;</div><div>&nbsp;</div><div>&nbsp;</div>

Location: Remote, US

  

Employment Type: Full-time Employment

  

Team: Clinical Delivery

  

 **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**  

This role requires an active RN license. Central Clinical Services enables
decentralized and hybrid clinical trials by providing staff who virtually
support patients and sites. The Central Study Coordinator (CSC) position
combines clinical research and project management skills into a singular role
that delivers a strong customer experience for both patients and sites. The
CSC acts as a virtual extension of the research site and supports one to four
sites concurrently across one or more studies. The CSC is accountable for
study delivery at the patient level, including screening, consenting, and
conducting protocol mandated study visits, and is expected to coordinate daily
work using patient centric practices and a quality-first approach. The CSC
also serves as a project manager for their assigned studies with their
assigned PIs, helping their sites to stay on top of study deliverables in line
with sponsor and CRO expectations. As such, this role will also manage
monitoring visits, data management, and query resolution for their assigned
sites, and ensure ongoing inspection readiness. This is a mid-to-senior level
individual contributor role with the expectation that the CSC has strong
working knowledge of and experience in the clinical research industry.  

    

 **What You'll Be Working On**  

 **Duties include but are not limited to:**  



 **CSC I:**  



Licensed RN in the state of Pennsylvania

Manage study work for each assigned site as delegated by the PI, collaborating
with multiple sites and site teams concurrently to deliver the highest quality
work with each participant for each site

Build strong rapport with sites, participants, CRAs, and sponsor contacts

Host regular calls with each assigned PI and present on key elements of the
study within CSC scope, which may include a review of new referrals,
participants in screening, participants in treatment, data and query progress
and issues, upcoming monitoring visits, etc.  

Prepare meeting agendas and circulate meeting minutes, follow-up on action
items for self and teammates

Make decisions that optimize the experience within the study for the
participant, PI, and other site staff

Facilitate communication between study site, CRA, and sponsor

Pre-screen and educate potential study participants on the study. Manage
participant referral portals and study specific applications in real time in
accordance with GCP  

Perform the Informed Consent process with study participants virtually using
e-consent technology. Review all elements of the ICF with the participant and
assess their understanding to ensure the protection of human participants in
clinical research. Complete signatures using the e-consent platform and
register participants in IWRS

Schedule, prepare for, and facilitate participant visits in accordance with
the study protocol. This may include overseeing the required scheduling,
logistics, technology requirements, and communication applications for
participants, central raters, investigators, and other study-related entities
such as MRI centers and infusion centers

Maintain all study documentation in accordance with ALCOA-C  

Enter data and resolve queries in EDC and other portals within appropriate
time window defined by the study

Perform quality checks for self and others to ensure overall data integrity

Complete ongoing trainings and adhere to system access guidelines

Correctly identify, document, and report AEs and SAEs

Analyze and understand study protocols  

Support site compliance with subject safety reporting

Ensure all study trackers and systems are up to date daily

Additional duties and responsibilities may be assigned as needed

  

 **CSC II includes all the above plus the following:**  



Manage and deliver special projects for the team

Support and guide others on understanding of the protocol and GCP

Train, mentor, and coach other CSCs on study conduct and CSC processes

Identify solutions to issues with study processes, proactively identify and
implement process improvements

Autonomously evaluate competing activities and decide on priorities based on
guidance provided by manager and study team



 ** **

  

 **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:**  



 **CSC I:**  

Able to navigate and troubleshoot a wide variety of technologies used for
clinical research including recruitment platforms, IWRS, EDC, and other
clinical trial software, and able to work across multiple platforms at the
same time

Proficient with Microsoft Office applications (Word, Outlook, Teams, and
Excel)

Demonstrate professionalism in all situations and work effectively with a
diverse group of individuals  

Understand when issues require escalation

Strong communication customer service abilities

Proficient in research terminology and basic medical terminology

Understand the overall clinical development paradigm and excellent working
knowledge of government regulations, GCP, and ALCOA-C

Strong organization and time management skills

High attention to detail

Ability to work in a fast-paced environment

Critical thinker and problem solver

Ability to work effectively in a remote environment

Proper home office set-up including a private space for participant
communication and high-speed internet (at minimum: 100MB up and 15 MB down, 5
GHz router)

  ** **  

 **CSC II includes all the above plus the following:**  

Advanced communication skills both verbally and in writing

Able to speak to all levels of an organization  

People mentoring abilities



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



 **CSC I:**  

At least 3 years of relevant clinical research experience

CCRC preferred

Fluency in Spanish is a bonus

Active Pennsylvania RN licensure

  

 ** **

 ** **

 **CSC II:**  

At least 4 years of relevant clinical research experience, and at least 1 year
as a high performing CSC I

CCRC preferred

Fluency in Spanish is a bonus

Active Pennsylvania RN licensure

** **

 ** **

 **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.





