Sub-Investigator NP/PA

Flourish Research•Walnut Creek, CA

3h•$72 - $82•Onsite

About The Position

Flourish Research is hiring an onsite Sub-Investigator to support its Walnut Creek site. The role works under the Primary Investigator and helps manage clinical-study participant safety, protocol adherence, participant care, and study documentation. The position is scheduled Monday through Friday on the day shift for 40 hours per week and is classified as exempt. Compensation is $72.00–$82.00 per hour. The Sub-Investigator performs study-related procedures and assessments, evaluates participant eligibility and investigational-product compliance, reviews laboratory results, assesses adverse experiences, and facilitates appropriate medical care and follow-up. The role also supports informed consent, maintains accurate source documents and case report forms, and communicates and reports safety information to sponsors, CROs, and IRBs as required. Flourish Research describes itself as a clinical trial organization working across several research areas and emphasizes inclusive, respectful care and a safe work environment. It offers a comprehensive benefits package, a collaborative work environment, and growth opportunities.

Requirements

One of the following degrees or credentials: M.D., D.O., D.N.P., A.P.R.N., P.A., or 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 regarding study participants’ health and safety.
Exceptional organizational and planning skills and good documentation skills.
Conflict-resolution skills and a 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; preferred but not required.

Responsibilities

Represent Flourish Research professionally and courteously in interactions with sponsors, physicians and their office personnel, participants, employees, contract personnel, and other people.
Maintain the confidentiality of participant information in accordance with applicable confidentiality agreements and HIPAA regulations.
Understand each study protocol, including applicable amendments.
Work under the Primary Investigator to manage participant safety, assess inclusion and exclusion criteria, monitor laboratory results, arrange appropriate follow-up, and maintain adherence to protocols and procedures.
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 follow-up in accordance with the protocol.
Maintain protocol compliance and follow the schedule of assessments; implement only sponsor/CRO- and IRB-approved protocol deviations or changes, except when necessary to eliminate an immediate participant hazard.
Understand and share information about eligibility criteria, procedures, scheduled visits, endpoint criteria, investigational article use, investigator brochures, product inserts, and other investigational-product information with the research team.
Assess participant compliance with investigational products and evaluate adverse experiences, including severity and relationship to the investigational product.
Ensure participants receive medical care for adverse events as needed.
Document and report serious adverse events to the sponsor/CRO and IRB within 24 hours of the site learning of the event.
Obtain signed and dated informed consent from the participant or legal representative before beginning study-related procedures; explain all aspects of the trial 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 participants’ medical records and Flourish Research CTMS, eDocs, and Source.
Administer tests, scales, and assessments according to established psychometric-testing standards and sponsor protocols to ensure validity and reliability.
Determine the reason for a participant’s premature study withdrawal.
Maintain professional and technical knowledge, including attending educational workshops and other activities to meet continuing medical education requirements and reviewing professional publications.