<p>Location: Baltimore, MD</p><br/><p>Employment Type: Full Time - Regular</p><br/><p>Team: Site Network 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 Site Manager is responsible for the most pivotal and complex protocols and study designs being conducted at Care Access Research sites. </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>&nbsp;</div><div><span style="font-size: 12pt">Duties include but not limited to:</span></div><div><b style="font-size: 12pt">Site Support Responsibilities:</b></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Supports Key Sponsors and CROs </span></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Manages some of the sites most challenging therapeutic areas and study designs </span></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Able to monitor and mentor all levels of CRCs to ensure complete understanding of Care Access Research processes, SOPs and values, ensuring that a successful transition to more demanding opportunities and responsibilities </span></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Assist Region Manager</span></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Assist Region Manager in performing quality control check of all study source documents for completeness and quality </span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 12pt">Therapeutic Responsibilities:</b></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Demonstrate deep knowledge about the therapeutic area of responsibility </span></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Demonstrate comprehensive understanding of related Protocol designs, outcomes and timelines </span></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Engage in continuous independent learning within the therapeutic area of responsibility</span></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Act as a primary point of contact in the therapeutic field for Care Access Research </span></div><div><b style="font-size: 12pt">&nbsp;</b></div><div><b style="font-size: 12pt">Study Preparation:</b></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&nbsp; </span><b style="font-size: 12pt">Study Management:</b></div><div><span style="font-size: 9pt">●</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: 9pt">●</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: 9pt">●</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: 9pt">●</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: 9pt">●</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><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 12pt">Patient Coordination:</b></div><div><span style="font-size: 9pt">●</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: 9pt">●</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: 9pt">●</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: 9pt">●</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: 9pt">●</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: 9pt">●</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><span style="font-size: 12pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 12pt">Documentation</b><span style="font-size: 12pt">:</span></div><div><span style="font-size: 9pt">●</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: 9pt">●</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: 9pt">●</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: 9pt">●</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">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><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><span style="font-size: 13pt">●</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp; </span><b style="font-size: 13pt">Physical and Travel Requirements</b></div><div><span style="font-size: 9pt">●</span><span style="font-size: 7pt">&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. </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 assigned and are not necessarily all-inclusive </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><span style="font-size: 12pt">Knowledge, Skills and Abilities:</span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Excellent working knowledge of medical and research terminology </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Excellent working knowledge of federal regulations, good clinical practices (GCP) </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Understanding of issues affecting clinical research in the identified therapeutic area of expertise </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Ability and willingness to mentor and guide less experienced CRC as they develop and gain experience in all therapeutic areas </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&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: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Excellent organizational, prioritization and leadership skills and capabilities with a strong attention to detail </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Excellent 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: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Critical thinker and problem solver </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Excellent interpersonal skills, detailed oriented and meticulous </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Friendly, outgoing personality with the ability to maintain a positive attitude under pressure </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">High level of self-motivation and energy </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Excellent professional writing and communication skills </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Ability to work independently in a fast-paced environment with minimal supervision </span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">Certifications/Licenses, Education, and Experience:</span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">RN or LPN/LVN preferred </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Research Professional Certification- CRCC preferred </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&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: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">A minimum of 5 years experience as a Clinical Research Coordinator required</span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&nbsp; </span><span style="font-size: 12pt">Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator </span></div><div><span style="font-size: 14pt">●</span><span style="font-size: 7pt">&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><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">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. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled.</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><span style="font-size: 12pt">Care Access currently is unable to sponsor work visas.&nbsp;</span></div>

Location: Baltimore, MD

  

Employment Type: Full Time - Regular

  

Team: Site Network 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 Site Manager is responsible for the most pivotal and complex protocols and
study designs being conducted at Care Access Research sites.



 **What You'll Be Working On**



Duties include but not limited to:

 **Site Support Responsibilities:**

●  Supports Key Sponsors and CROs

●  Manages some of the sites most challenging therapeutic areas and study
designs

●  Able to monitor and mentor all levels of CRCs to ensure complete
understanding of Care Access Research processes, SOPs and values, ensuring
that a successful transition to more demanding opportunities and
responsibilities

●  Assist Region Manager

●  Assist Region Manager in performing quality control check of all study
source documents for completeness and quality



 **Therapeutic Responsibilities:**

●  Demonstrate deep knowledge about the therapeutic area of responsibility

●  Demonstrate comprehensive understanding of related Protocol designs,
outcomes and timelines

●  Engage in continuous independent learning within the therapeutic area of
responsibility

●  Act as a primary point of contact in the therapeutic field for Care Access
Research

** **

 **Study Preparation:**

●  **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.



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



 **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)

●  Understanding of issues affecting clinical research in the identified
therapeutic area of expertise

●  Ability and willingness to mentor and guide less experienced CRC as they
develop and gain experience in all therapeutic areas

●  Ability to communicate and work effectively with a diverse team of
professionals

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

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

●  Critical thinker and problem solver

●  Excellent interpersonal skills, detailed oriented and meticulous

●  Friendly, outgoing personality with the ability to 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:

●  RN or LPN/LVN preferred

●  Research Professional Certification- CRCC preferred

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

●  A minimum of 5 years experience as a Clinical Research Coordinator 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 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.



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 currently is unable to sponsor work visas.

