<p>Location: Sun City Center, FL</p><br/><p>Employment Type: Full Time - Regular</p><br/><p>Team: Site Conduct</p><br/><div><b style="font-size: 13pt;">Clinical Research Coordinator II</b></div><div>______________________________________________________________________________________</div><div><b style="font-size: 13pt;">&nbsp;</b></div><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 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.</span></div><div><span style="font-size: 12pt;">&nbsp;</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;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Ability to understand and follow institutional SOPs.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Review and assess protocol (including amendments) for clarity, logistical feasibility</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Ensure that all training and study requirements are met prior to trial conduct.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Assist with planning and creation of appropriate recruitment materials.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Actively work with recruitment team in calling and recruiting subjects </span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Attend Investigator meetings as required. </span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Assist in the creation and review of source documents.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b style="font-size: 12pt;">Study Management:</b></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Prioritize activities with specific regard to protocol timelines</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Maintain effective relationships with study participants and other care Access Research personnel.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Communicate clearly verbally and in writing.</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b style="font-size: 12pt;">Patient Coordination:</b></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Prescreen study candidates </span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Obtain informed consent per Care Access Research SOP .</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Complete visit procedures in accordance with protocol.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b style="font-size: 12pt;">Documentation</b><span style="font-size: 12pt;">:</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Record data legibly and enter in real time on paper or e-source documents </span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Accurately record study medication inventory, medication dispensation, and patient compliance.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Resolve data management queries and correct source data within sponsor provided timelines</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Assist regulatory personnel with completion and filing of regulatory documents.</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><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;">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; </span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b style="font-size: 13pt;">What You Bring</b></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><b style="font-size: 12pt;">Knowledge, Skills, and Abilities:</b></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Excellent working knowledge of medical and research terminology</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Excellent working knowledge of federal regulations, good clinical practices (GCP)</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Ability to communicate and work effectively with a diverse team of professionals.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Critical thinker and problem solver</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Friendly, outgoing personality; maintain a positive attitude under pressure.</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">High level of self-motivation and energy</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Excellent professional writing and communication skills</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Ability to work independently in a fast-paced environment with minimal supervision.</span></div><div><b style="font-size: 12pt;">&nbsp;</b></div><div><b style="font-size: 12pt;">Certifications/Licenses, Education, and Experience:</b></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&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; </span><span style="font-size: 12pt;">A minimum of 3 years prior Clinical Research Coordinator experience required</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator &nbsp;</span></div><div><span style="font-size: 12pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Recent phlebotomy experience required</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div><span style="font-size: 12pt;">&nbsp;</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: 13.5pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">PTO/vacation days, sick days, holidays. </span></div><div><span style="font-size: 13.5pt;">●</span><span style="font-size: 7pt;">&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: 13.5pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">HSA plan</span></div><div><span style="font-size: 13.5pt;">●</span><span style="font-size: 7pt;">&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: 13.5pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">Culture of growth and equality</span></div><div><span style="font-size: 13.5pt;">●</span><span style="font-size: 7pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt;">401k retirement plan</span></div><div><span style="font-size: 12pt;">&nbsp;</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;">&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</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 currently unable to sponsor work visas.</span></div><div><span style="font-size: 12pt;">&nbsp;</span></div><div>&nbsp;</div>

Location: Sun City Center, FL

  

Employment Type: Full Time - Regular

  

Team: Site Conduct

  

 **Clinical Research Coordinator II**

______________________________________________________________________________________

 ** **

 **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.



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

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 currently unable to sponsor work visas.





