Principal Investigator

About Us:

Flourish Research is where clinical trials thrive. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

About the Job:

We are actively hiring a Principal Investigator to support our Northridge site.

Shift: Monday-Friday day shift (40 hours per week)

Location: Onsite

FLSA Classification: Exempt

Compensation: $300,000-$350,000

Requirements

PURPOSE: To ensure adherence to protocol requirements, participant safety, data integrity and direct and oversee the conduct of the clinical investigation according to Flourish Research standard operating procedures (SOPs), policies and procedures, federal and state regulations, medical ethics, Good Clinical Practices (GCPs), International Council of Harmonization (ICH) guidelines, Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. All responsibilities should be completed in accordance with Flourish Research’s Core Values and Employee Manual.

JOB RELATIONSHIPS:

Reports to: Site Director

Departments Supervised: N/A

ESSENTIAL JOB FUNCTIONS:

• Ensure the maintenance of confidentiality by team members of participant information as appropriate and as bound by Confidentiality Agreements with Flourish Research, between Flourish Research and sponsors/CROs and between Flourish Research and other entities while abiding by HIPAA regulations.
• Assume overall responsibility of the success of Flourish Research under the direction of the CEO.
• Possess a thorough knowledge and understanding of the requirements of each study protocol.
• Determine whether inclusion/exclusion criteria are applicable to the study population.
• Follow each study's randomization procedures.
• Maintain protocol compliance and does not implement any protocol deviation or changes without agreement by the sponsor/CRO and prior review and approval by the IRB (except to eliminate immediate hazards to the participant).
• Review the inclusion/exclusion criteria, procedures, scheduled visits, end point criteria and investigational article use with the research team.
• Ensure that a qualified physician is responsible for all trial-related medical decisions.
• Assess participant compliance with the test article and follow-up visits.
• Assess participant's response to therapy.
• Evaluate for adverse experiences and determine severity and relationship to the
• investigational product.
• Ensure that medical care is provided to a participant for any adverse event(s).
• Document and report all serious adverse events immediately to the sponsor/CRO and IRB.
• Obtain a signed and dated informed consent from the study participant or participant's legal representative prior to initiating any study-related procedures.
• Inform the participant or legal representative about all aspects of the clinical trial.
• Always consider participant safety and welfare the first priority.
• Ensure the accuracy, completeness, legibility, and timeliness of case report forms (CRFs).
• Explain any discrepancies between source documents and case report forms (CRFs).
• Endorse changes or corrections to a case report form (CRF).
• Review and signs data management queries and case report forms (CRFs) in a timely manner.
• Document deviations from the approved protocol.
• Document and explain premature un-blinding of the investigational product(s).
• Document that informed consent has been obtained from the participant or legal
• representative.