Principal Investigator

Flourish Research•Jacksonville, FL

6d•Onsite

About The Position

Flourish Research is actively hiring a Principal Investigator to support our Jacksonville site. The purpose of this role is to ensure adherence to protocol requirements, participant safety, data integrity, and to 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.

Requirements

Medical (M.D.) degree, Doctor of Osteopathy (D.O.), Doctor of Nursing Practice (D.N.P.), Doctor of Psychology (PsyD).
A minimum of 2 years’ experience in performing physicals, assessing, and treating patients.
1-3+ years' experience within the field of clinical research or biological research.
Exceptional knowledge of clinical research methods.
Strong supervision, interpersonal and communication skills.
Able to make good, sound decisions under stress and time constraints.
Must be able to make sound medical judgments on the health and safety of subjects during their participation in a clinical research study.
Maintain professional and technical knowledge by attending educational workshops in other activities to maintain continuing medical education requirements.
Review professional publications.
Must possess exceptional organizational and planning skills and good documentation skills.
Must have good conflict resolution skills and be committed to quality and honesty.
In-depth knowledge of the clinical research process, including Good Clinical Practices.
Completes at least 80% of goals annually.
Flexible and able to multi-task and prioritize competing demands.

Responsibilities

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.
May perform clinical interviews and administer a variety of psychological tests, clinical rating scales, and/or diagnostic assessments.
Evaluate results through scoring and documented findings in subjects’ medical records and Flourish Research CTMS, eDocs, Source.
Ensure validity and reliability when administering tests/scales/assessments by complying with established standards for administering psychometric testing and per sponsors’ protocols.
Ascertain the reason for a participant’s premature study withdrawal.
Comply with written procedures to document changes to data and/or case report forms (CRFs).
Develop thorough knowledge and familiarity with the use of the investigational product(s).
Read the current investigator’s brochure, product insert, or other source information.
Represent Flourish Research in a professional and courteous manner (verbal, written, and in appearance) during all interactions with sponsors, physicians, physicians' office personnel, participants, Flourish Research employees, Flourish Research contract personnel, as well as any other person(s) when carrying out task and responsibilities.
Additional duties as assigned by management.