<p>Location: Youngstown, OH</p><br/><p>Employment Type: Full-time Employment</p><br/><p>Team: Clinical Research Coordinator (CRC)</p><br/><div><b>What We Do</b></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.</div><div><br></div><div><b>Who We Are</b></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;</div><div><br></div><div><b>Position Overview</b></div><div>The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.</div><div><br></div><div><b>What You'll Be Working On</b></div><div><b>Duties include but not limited to:</b></div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to understand and follow institutional SOPs.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Review and assess protocol (including amendments) for clarity, logistical feasibility</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure that all training and study requirements are met prior to trial conduct.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assist with planning and creation of appropriate recruitment materials.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Actively work with recruitment team in calling and recruiting subjects </div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Attend Investigator meetings as required. </div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assist in the creation and review of source documents.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)</div><div><br></div><div><b>Study Management:</b></div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prioritize activities with specific regard to protocol timelines</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Maintain effective relationships with study participants and other care Access Research personnel.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Communicate clearly verbally and in writing.</div><div>&nbsp;</div><div><b>Patient Coordination:</b></div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prescreen study candidates </div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Obtain informed consent per Care Access Research SOP .</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Complete visit procedures in accordance with protocol.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)</div><div>&nbsp;</div><div><b>Documentation</b>:</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Record data legibly and enter in real time on paper or e-source documents </div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Accurately record study medication inventory, medication dispensation, and patient compliance.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Resolve data management queries and correct source data within sponsor provided timelines</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Assist regulatory personnel with completion and filing of regulatory documents.</div><div>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.</div><div><br></div><div><b>Physical and Travel Requirements</b></div><div>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role.&nbsp; </div><div>&nbsp;</div><div><b>What You Bring</b></div><div>&nbsp;</div><div><b>Knowledge, Skills, and Abilities:</b></div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent working knowledge of medical and research terminology</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent working knowledge of federal regulations, good clinical practices (GCP)</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to communicate and work effectively with a diverse team of professionals.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Critical thinker and problem solver</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Friendly, outgoing personality; maintain a positive attitude under pressure.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; High level of self-motivation and energy</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Excellent professional writing and communication skills</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ability to work independently in a fast-paced environment with minimal supervision.</div><div><b>&nbsp;</b></div><div><b>Certifications/Licenses, Education, and Experience:</b></div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Bachelor’s Degree preferred, or equivalent combination of education, training and experience.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; A minimum of 3 years prior Clinical Research Coordinator experience required</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator &nbsp;</div><div>●&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Recent phlebotomy experience required</div><div>&nbsp;</div><div><b>Benefits (US Full-Time Employees Only)</b></div><div>●&nbsp;&nbsp;&nbsp;&nbsp; PTO/vacation days, sick days, holidays. </div><div>●&nbsp;&nbsp;&nbsp;&nbsp; 100% paid medical, dental, and vision Insurance. 75% for dependents.</div><div>●&nbsp;&nbsp;&nbsp;&nbsp; HSA plan</div><div>●&nbsp;&nbsp;&nbsp;&nbsp; Short-term disability, long-term disability, and life Insurance. </div><div>●&nbsp;&nbsp;&nbsp;&nbsp; Culture of growth and equality</div><div>●&nbsp;&nbsp;&nbsp;&nbsp; 401k retirement plan</div><div><b>Diversity &amp; Inclusion</b></div><div><br></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. We do not discriminate based on race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status.</div><div>&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. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled service model. </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.</div><div>&nbsp;</div><div>Care Access is unable to sponsor work visas at this time.</div>

Location: Youngstown, OH

  

Employment Type: Full-time Employment

  

Team: Clinical Research Coordinator (CRC)

  

 **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 Clinical Research Coordinator’s primary responsibilities are to utilize
Good Clinical Practices (GCP)s in the process of screening, enrolling and
closely monitoring clinical research study subjects while ensuring protocol
and regulatory compliance.

  

 **What You'll Be Working On**

 **Duties include but not limited to:**

●       Ability to understand and follow institutional SOPs.

●       Review and assess protocol (including amendments) for clarity,
logistical feasibility

●       Ensure that all training and study requirements are met prior to trial
conduct.

●       Discuss study medication, required procedures, eligibility criteria
and impact on office flow with Investigator and site staff.

●       Assist with planning and creation of appropriate recruitment
materials.

●       Assist in development of recruitment plan and obtain listing of
potential candidates to contact from subject database.

●       Actively work with recruitment team in calling and recruiting subjects

●       Attend Investigator meetings as required.

●       Coordinate and attend pre-study site visits, site initiation visits,
and monitor visits with clinical staff and Sponsor/CRO representatives.

●       Assist in the creation and review of source documents.

●       Ensure adequate supplies have arrived on site for protocol initiation
(lab kits, study medication, specialized equipment, IVRS/EDC access and
passwords)

  

 **Study Management:**

●       Prioritize activities with specific regard to protocol timelines

●       Maintain adherence to FDA regulations and ICH guidelines in all
aspects of conducting clinical trials.

●       Maintain effective relationships with study participants and other
care Access Research personnel.

●       Interact in a positive, professional manner with patients, sponsor
representatives, investigators and Care Access Research personnel and
management.

●       Communicate clearly verbally and in writing.



 **Patient Coordination:**

●       Prescreen study candidates

●       Obtain informed consent per Care Access Research SOP .

●       Complete visit procedures in accordance with protocol.

●       Train others and complete basic clinical procedures, such as blood
draws, vital signs, ECGs, etc.

●       Review laboratory results, ECGs, and other test results (e.g., MRIs)
for completeness and alert values, ensuring investigator review in a timely
fashion.

●       Identify adverse events (AEs) and Serious Adverse Events (SAEs) and
promptly notify Principal Investigator and Sponsor (where appropriate)



 **Documentation** :

●       Record data legibly and enter in real time on paper or e-source
documents

●       Accurately record study medication inventory, medication dispensation,
and patient compliance.

●       Resolve data management queries and correct source data within sponsor
provided timelines

●       Assist regulatory personnel with completion and filing of regulatory
documents.

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.

  

 **Physical and Travel Requirements**

·         This is an on-site position with regional commute requirements.
Regularly planned travel within the region will be required as part of the
role.



 **What You Bring**



 **Knowledge, Skills, and Abilities:**

●       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, prioritization and leadership skills and
capabilities with a strong attention to detail

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

●       Critical thinker and problem solver

●       Friendly, outgoing personality; maintain a positive attitude under
pressure.

●       High level of self-motivation and energy

●       Excellent professional writing and communication skills

●       Ability to work independently in a fast-paced environment with minimal
supervision.

 ** **

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

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

●       A minimum of 3 years prior Clinical Research Coordinator experience
required

●       Prefer 1 year of experience as a Care Access Research Clinical
Research Coordinator  

●       Recent phlebotomy experience required



 **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. We do not discriminate based on race, sex, religion, color, national
origin, gender identity, age, marital status, veteran status, or disability
status.



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. Our team of experts is paving the way to
take this vision forward through innovation and a unique technology-enabled
service model.



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.

