Clinical Results and Medical Consult Sub-Investigator

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