Sub-Investigator

Flourish Research•Chicago, IL

3d•Onsite

About The Position

Flourish Research is hiring an onsite Sub-Investigator to support its Ravenswood site in Chicago, Illinois. The role ensures adherence to clinical trial protocols, participant safety, and data integrity. Working under the Primary Investigator, the Sub-Investigator helps direct and oversee clinical investigations in accordance with Flourish Research standard operating procedures and policies, applicable federal and state regulations, medical ethics, Good Clinical Practices, ICH guidelines, IRB requirements, and sponsor protocol requirements. The Sub-Investigator performs study-related clinical procedures and assessments, manages participant safety and care, evaluates laboratory results and adverse experiences, and ensures appropriate follow-up. The role also supports informed consent, protocol compliance, and accurate, timely study documentation. The position is scheduled Monday through Friday on the day shift for 40 hours per week and is classified as exempt. Work is normally performed in a typical interior clinical or office environment and involves participant care.

Requirements

Medical degree (M.D.), Doctor of Osteopathy (D.O.), Doctor of Nursing Practice (D.N.P.), Advanced Practice Registered Nurse (A.P.R.N.), Physician’s Assistant (P.A.), or Doctor of Psychology (PsyD).
At least 2 years of experience performing physical examinations, assessing patients, and treating patients.
Strong supervision, interpersonal, and communication skills.
Ability to make sound decisions under stress and time constraints.
Ability to make sound medical judgments concerning participant health and safety during clinical research studies.
Maintain professional and technical knowledge through educational workshops and other activities to meet continuing medical education requirements.
Review professional publications.
Strong organizational, planning, and documentation skills.
Conflict-resolution skills and commitment to quality and honesty.
In-depth knowledge of the clinical research process, including Good Clinical Practices.

Nice To Haves

1–3+ years of experience in clinical research or biological research; this experience is preferred but not required.

Responsibilities

Represent Flourish Research professionally and courteously when interacting with sponsors, physicians, participants, employees, contract personnel, and others.
Maintain the confidentiality of participant information in accordance with applicable agreements and HIPAA regulations.
Understand each study protocol and its amendments.
Work under the Primary Investigator to manage participant safety, assess eligibility criteria, monitor laboratory results, arrange follow-up, and maintain protocol adherence.
Perform study-related procedures, injections, physical examinations, clinical interviews, clinical rating scales, psychological testing, and neurological assessments.
Interpret laboratory results, facilitate participant care, and ensure protocol-required follow-up.
Follow the protocol schedule of assessments and implement only sponsor/CRO- and IRB-approved protocol changes, except when needed to eliminate immediate hazards to a participant.
Know and share relevant information about eligibility criteria, procedures, visit schedules, endpoint criteria, investigational products, and applicable source information with the research team.
Assess participant compliance with investigational products and evaluate adverse experiences for severity and relationship to the investigational product.
Ensure participants receive medical care for adverse events as needed.
Report serious adverse events to the sponsor/CRO and IRB within 24 hours of the site’s knowledge of the event.
Obtain signed and dated informed consent from the participant or legal representative before study-related procedures begin, explain trial aspects, and document that consent was obtained.
Prioritize participant safety and welfare.
Ensure source documentation and case report forms are accurate, complete, legible, and timely.
Review and sign data management queries and case report forms in a timely manner, as applicable.
Document and explain premature unblinding of investigational products when necessary.
Evaluate results and document findings in participant medical records and Flourish Research CTMS, eDocs, and Source.
Administer tests, scales, and assessments according to established psychometric testing standards and sponsor protocols.
Determine the reason for a participant’s premature study withdrawal.