Clinical Results and Medical Consult Sub-Investigator

What We Do

Who We Are

Position Overview

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

Employment Statement