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Care Access · 15 hours ago

Clinical Results and Medical Consult Sub-Investigator

United States

Full-time

Remote

Entry, Mid Level

2+ years exp

Care Access is working to improve health accessibility globally through innovative research and health services. The Clinical Results and Medical Consult Sub-Investigator will manage patient communications regarding abnormal test results, provide medical consults, and ensure compliance with clinical protocols and regulations.

Clinical TrialsHealth Care

No H1B

Responsibilities

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

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

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

Qualification

Clinical research experienceActive NPPA licenseClinical Practice (GCP)Telehealth experienceMedical terminology knowledgeClient service mentalityCommunication skillsOrganizational skillsTeam collaboration skillsCritical thinking

Required

Minimum of 2 years of clinical experience as APP

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

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

Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors

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