Principal Investigator

Flourish Research•Jacksonville, FL

8d•Onsite

About The Position

Flourish Research is seeking a motivated Principal Investigator to join our Jacksonville site. This role is crucial for ensuring the integrity and safety of clinical trials. The Principal Investigator will oversee and direct the conduct of clinical investigations, adhering strictly to protocol requirements, participant safety, data integrity, and all relevant regulations and guidelines. We are committed to fostering a diverse and inclusive environment where all employees, customers, and patients are treated with dignity and respect. This position offers an excellent benefits package, a supportive work environment, and opportunities for career growth.

Requirements

Medical (M.D.) degree, Doctor of Osteopathy (D.O.), Doctor of Nursing Practice (D.N.P.), or 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.
Ability to make good, sound decisions under stress and time constraints.
Ability to make sound medical judgments on the health and safety of subjects.
Maintain professional and technical knowledge by attending educational workshops and maintaining continuing medical education requirements.
Review professional publications.
Exceptional organizational and planning skills.
Good documentation skills.
Good conflict resolution skills.
Commitment 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.
Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.
Ability to drive and daily availability of an automobile.

Responsibilities

Ensure adherence to protocol requirements, participant safety, and data integrity.
Direct and oversee the conduct of clinical investigations according to SOPs, policies, procedures, federal and state regulations, medical ethics, GCPs, ICH guidelines, IRB requirements, and sponsor protocol requirements.
Maintain confidentiality of participant information in compliance with HIPAA regulations.
Assume overall responsibility for the success of the clinical trial under the direction of the CEO.
Possess a thorough knowledge and understanding of each study protocol's requirements.
Determine the applicability of inclusion/exclusion criteria to the study population.
Follow each study's randomization procedures.
Maintain protocol compliance and prevent deviations or changes without sponsor/CRO agreement and IRB approval (except to eliminate immediate hazards).
Review inclusion/exclusion criteria, procedures, scheduled visits, endpoint criteria, and investigational article use with the research team.
Ensure 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 adverse experiences, determine severity, and relationship to the investigational product.
Ensure medical care is provided for any adverse event(s).
Document and report all serious adverse events immediately to the sponsor/CRO and IRB.
Obtain signed and dated informed consent from the study participant or legal representative prior to initiating study-related procedures.
Inform the participant or legal representative about all aspects of the clinical trial.
Prioritize participant safety and welfare.
Ensure the accuracy, completeness, legibility, and timeliness of case report forms (CRFs).
Explain discrepancies between source documents and CRFs.
Endorse changes or corrections to CRFs.
Review and sign data management queries and CRFs in a timely manner.
Document deviations from the approved protocol.
Document and explain premature un-blinding of investigational product(s).
Document that informed consent has been obtained.
May perform clinical interviews and administer 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.
Ascertain the reason for a participant’s premature study withdrawal.
Comply with written procedures to document changes to data and/or CRFs.
Develop thorough knowledge and familiarity with the use of investigational product(s).
Read the current investigator’s brochure, product insert, or other source information.
Represent Flourish Research professionally and courteously in all interactions.
Perform additional duties as assigned by management.