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Clinical Results and Medical Consult Sub-Investigator

Remote: 
Full Remote
Contract: 
Full time
Work from: 
United States

Offer summary

Qualifications:

Minimum of 2 years of clinical experience as an Advanced Practice Provider (APP), Active unrestricted Nurse Practitioner (NP) or Physician Assistant (PA) license, Strong knowledge of medical and research terminology, federal regulations, and good clinical practices (GCP), Excellent communication skills and ability to work independently in a fast-paced environment..

Key responsibilities:

  • Manage communication of abnormal test results to patients and provide medical consults
  • Collaborate with RN, Member Services, and site teams to ensure proper patient interaction management
  • Oversee execution of study protocols and ensure compliance with clinical standards
  • Document all communications and follow-up actions accurately in patient progress notes.

Care Access logo
Care Access Research SME https://www.careaccess.com/
501 - 1000 Employees
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Job description

What We Do
Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers.

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 Advanced Practice Provider (APP) in this role will manage the communication of abnormal test results to patients and provide medical consults. The APP will function within their scope of practice ensuring compliance with state licensure requirements. This includes contacting patients, documenting communications, following up on medical escalations, and collaborating with RN, Member Services, and site teams to ensure all patient interactions are appropriately managed and documented. This role is critical in ensuring timely patient communication and maintaining compliance with clinical and legal standards. 

What You'll Be Working On (Duties include but not limited to):
  • Clinical Results and Medical Consult Management: 
  • Receive and Review Results: Receive flagged abnormal, urgent, or critical test results and ensure they are ready for patient communication. Review and sign off on test results as defined by the program requirements and within scope of practice where licensed. 
  • Patient Communication: Contact patients to communicate abnormal test results, ensuring focused, uninterrupted time for calls due to potential challenges in reaching patients. Provide personalized medical consult either separately or combined with test result calls. Discuss potential study opportunities and refer as appropriate.   
  • Medical Escalations: Address and/or triage test-related or other medical escalations from the Member Services team, RN team, and site teams, such as result clarifications, member requests for medical advice/test interpretation, and communicate resolutions back to the patient, documenting the outcome. 

  • Sub-Investigator: 
  • 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.   
  • Read and understand the informed consent form, protocol, and investigator's brochure  
  • Be available to see subjects, 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   
  • Review screening documentation and approves subjects for admission to study   
  • Review admission documentation and approves subject for randomization   
  • Provide ongoing assessment of the study subject to identify Adverse Events   
  • Ensure that serious and unexpected adverse events are reported promptly to the Pl   
  • Review and evaluates all study data and comments to the clinical significance of any out-of-range results   
  • Perform physical examinations as part of screening evaluation and active study conduct   
  • Provide medical management of adverse events as appropriate 

  • Other Responsibilities 
  • Documentation: Accurately document all communications in patient progress notes, including abnormal results, patient concerns, and follow-up actions. Ensure compliance with part-11 signature requirements.  

    • Scope of Role
  • Autonomy of Role: ​Work is performed under limited supervision​ 

    • Physical Requirements
  • Physical demands associated with onsite duties include:  
  • Walking
  • Standing
  • Sitting

  • Lifting:
  • up to 25 lbs
  • over 25 lbs
  • overhead

  • Driving 

    • Travel Requirements:
  • This role requires up to 100% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.  
  • Type of travel required: ​National​ 


    • What You Bring (Knowledge, Skills, and Abilities):
  • Excellent communication and patient interaction skills
  • Strong attention to detail and ability to manage multiple patients efficiently
  • Ability to work independently while collaborating with a larger clinical team
  • 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
  • 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, innovate, able to take thoughtful risks and get things done
  • Friendly, outgoing personality; maintain a positive attitude under pressure
  • High level of self-motivation and energy
  • Ability to work independently in a fast-paced environment with minimal supervision
  • Must have a client service mentality

    • Certifications, Education, and Experience:
  • Minimum of 2 years of clinical experience as APP  
  • Clinical research experience preferred 
  • Telehealth experience preferred 

    • Licenses:
  • Active unrestricted NP or PA license  
  • Multi-state licensure required 
  • Willingness to maintain and obtain additional state licenses as needed. Must hold all licenses in good standing. 

    • 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.

    Required profile

    Experience

    Industry :
    Research
    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Hard Skills

    Communicating With PatientsRegulatory ComplianceClinical AssessmentsMedical AffairsGood Clinical Practices (GCP)Project CollaborationMedical AbbreviationsTelehealthClinical Assessments

    Other Skills

    • Critical Thinking
    • Organizational Skills
    • Detail Oriented
    • Computer Literacy
    • Problem Solving
    • Communication
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