Clinical Results and Medical Consult Sub-Investigator

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.

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