Location: Quincy, MA

  

Employment Type: Full Time - Regular

  

Team: Site Conduct

  

 **What We Do**

Care Access is a unique, multi-specialty network of research sites which
operates as one connected team of physician investigators, nurse coordinators,
and operations managers. Our goal is to engage every healthcare professional
in clinical research and to make clinical trials a care option for every
patient. 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 Sub-Investigator II will be responsible for regional travel mixed with
remote tele-medicine work to support our clinical research studies.
Additionally, our Sub-Investigator II’s will be skilled in administering
investigational products (IV, SC, TD, IM, PO administration), performing
physical examinations, monitoring for investigational product related
reactions, among other duties beyond the standard clinical research Sub-
Investigator role. Care Access is looking for highly motivated Nurse
Practitioners or Physician’s Assistants to support clinical trial related
activities in states throughout the USA.



 _ **What You’ll Be Working On**_

 **Duties include but not limited to:**

 ** **

·       Work closely with the Principal Investigator to oversee the execution
of study protocols, delegating study related duties to site staff, as
appropriate, and ensuring site compliance with study protocols, study-specific
laboratory procedures, standards of Good Clinical Practice (GCP), Standard
Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and
other state and local regulations as applicable.

·       Attends and participates in meetings with the director, other
managers, and staff as necessary.

·       Complies with regulatory requirements, policies, procedures, and
standards of practice.

·       Read and understand the informed consent form, protocol, and
investigator's brochure.

·        Be available to see subjects virtually or in-person as dictated by
project design, answer their questions, and resolve medical issues during the
study visit.

·        Sign and ensure that the study documentation for each study visit is
completed.

·        Perform all study responsibilities in compliance with the IRB
approved protocol.

·        Administration of Investigational Products (via subcutaneous,
transdermal, intramuscular, intravenous, or oral routes).

·        Proficiency in starting, monitoring, and maintaining intravenous
lines.

·        Proficiency in phlebotomy, proper blood collection practices, and
laboratory processing practices (can be learned)

·        Contribute as an active member of clinicians involved in the
management of infusion or other investigational product related reactions.

·        Maintain a clean, efficient clinical area to assure the highest
standards of patient care.

·        Follow safety and PPE procedures as well as maintain proper
documentation of infusion procedures.

·        Timely communications with internal teams, investigators, review
boards, and study subjects

·        Perform trial procedures as per delegation which can include the
following but not limited to:

·        Prescreen study candidates by telephone and review exclusionary
conditions or medications prior to scheduling screening appointment.

○      Obtain informed consent per SOP.

○      Administer delegated study questionnaires, as appropriate.

○      Collect and evaluate medical records.

○      Complete visit procedures and ensure proper specimen collection,
processing, and shipment in accordance with protocol.

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

○      Review screening documentation and approves subjects for admission to
study.

○      Review admission documentation and approves subject for randomization.

o   Provide ongoing assessment of the study subject/patient to identify
Adverse Events.

o   Ensure that serious and unexpected adverse events are reported promptly to
the Pl.

o   Review and evaluates all study data and comments to the clinical
significance of any out-of-range results.

o   Perform physical examinations as part of screening evaluation and active
study conduct.

o   Provide medical management of adverse events as appropriate.

o   Dispense study medication per protocol and/or IVRS systems. Educate
patient on proper administration and importance of compliance.

o   Monitor patient progress on study medication.

o   Other duties as assigned.



  _ **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:**

·        Ability to check, perform, and document vitals as well as EKG (ECG)

·        Phlebotomy and expert IV skills

·        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 skills: Able to prioritize, support, and follow
through on assignments with good understanding of medical terminology.

·        Communication Skills: Strong verbal and written communication skills
as evidenced by positive interactions with coworkers, management, clients and
vendors.

·        Communication Skills: Strong verbal and written communication skills
as evidenced by positive interactions with coworkers, management, clients and
vendors.

·        Team Collaboration Skills: Work effectively and collaboratively with
other team members to accomplish mutual goals. Bring positive and supportive
attitude to achieving these goals.

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

·        Ability to balance tasks with competing priorities.

·        Critical thinker and problem solver.

·        Curiosity and passion to learn, innovative, and able to take
thoughtful risks while communicating concerns and mitigations.

·        Good management and organizational skills, understanding of medical
procedures.

·        Exceptional interpersonal skills, willingness to the ability to work
independently.

·        Ability to lift a minimum of 50 pounds.

·        Command of professional and Business English (written and spoken).

·        You must have the authorization to work in the US for any employer.

·        You must not need visa sponsorship, either now or in the future.

·        You must live in the USA and be willing and able to travel with
24–36-hour notice





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

·       At least Master’s Level Science Degree.  Nurse Practitioner or
Physician Assistant with 5+ years of clinical experience.

·       Clinical Practice Experience Desired with Infusion Skillset.

·       Currently licensed in good standing in one or more states.

·       A minimum of 1 year of relevant work experience as Sub-Investigator
(preferred) in a Clinical Research setting.

·       Preferred at least one (1) year of experience as a Clinical Research
Coordinator or willingness to learn.



 **Benefits (US Full-Time Employees Only)**

·        Paid Time Off (PTO) and Company Paid Holidays

·        100% Employer paid medical, dental, and vision insurance plan options

·        Health Savings Account and Flexible Spending Accounts

·        Bi-weekly HSA employer contribution

·        Company paid Short-Term Disability and Long-Term Disability

·        401(k) Retirement Plan, with Company Match

 **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 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.

