Location: Remote, US
Employment Type: Full Time - Regular
Team: Sub Investigators
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.
**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.
Physical demands associated with onsite duties include:
Walking
Standing
Sitting
Lifting:
up to 25 lbs
over 25 lbs
overhead
Driving
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.