Sub-Investigator (with Infusion)- Quincy, MA

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)

· 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 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.