Job Description

Highland Performance Solutions is proud to be leading a retained search for Flourish Research for a Sub-Investigator at the de novo site in Little Haiti, FL. This role is onsite and requires conversational language proficiency in Haitian Creole.

Who We Are

Advancing the health and wellness of society through clinical trials, Flourish Research is one of the largest integrated clinical research site companies in the US, with best-in-class sites who have a strong brand and track-record of recruiting and retaining a highly diversified patient populations in the therapeutic areas of cardiology, metabolic disorders/renal, CNS, pulmonology, and vaccines. Flourish’s fully integrated site network strategy with centralized infrastructure and investment in technology allows for superior patient access, engagement, and diversification as well as consistent, high quality data delivery. Flourish has differentiated its sites through an investment in Quality Management Systems, a focus on patient diversity, and deep clinical expertise backed by SMEs in its Centers of Excellence focus areas.

The Role & Opportunity

As a Sub-Investigator, to ensure adherence to protocol requirements, participant safety, and data integrity. Direct and oversee the conduct of the clinical investigation according to Flourish Research standard operating procedures (SOPs) and policies, 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. This is an onsite role that reports to the Site Director.

Key Responsibilities

• 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 tasks and responsibilities.
• Ensure the maintenance of confidentiality of participant information by team members 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.
• Contact and engage patients to discuss their interest in participating in clinical studies.
• Ensure familiarity with eligibility criteria to accurately schedule qualified participants.
• Inform patients about their eligibility for a clinical trial and notify those who do not qualify while discussing alternative study opportunities that may be available.
• Be prepared to step in and assist with any aspect of trial execution, maintaining high standards and strict compliance with study protocols ensuring all procedures and requirements are completed accurately and efficiently per protocol.
• Possess a thorough knowledge and understanding of the requirements of each study protocol including any amendment changes, as applicable.
• Work closely under the Primary Investigator to manage the safety of study participants, assess inclusionary and exclusionary study criteria, monitor laboratory results, ensure appropriate follow up as necessary, and maintain adherence to study protocol and procedures.
• Perform protocol-related procedures, injections, physical examinations, clinical interviews, clinical rating scales, psychological testing, and neurological assessments. Interpret laboratory results, facilitate participant care, and ensure appropriate follow up per protocol.
• Maintain protocol compliance, including following schedule of assessments, implementing only protocol deviations or changes approved by the sponsor/CRO and IRB (except to eliminate immediate hazards to the participant).
• Acquire thorough knowledge of the inclusion/exclusion criteria, procedures, scheduled visits, end point criteria, and investigational articles use and share relevant information with the research team to include information in the current investigator’s brochure, product insert, or other source information, as well as other information about the investigational product(s).
• Assess participant compliance to investigational product. Evaluate 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) as needed.
• Document and report all serious adverse events to the sponsor/CRO and IRB within 24 hours of the site’s knowledge of the event.
• Conduct appropriate informed consent procedures to obtain signed and dated informed consent from the study participant or participant's legal representative prior to initiating any study-related procedures, including documentation that the informed consent has been fully executed prior to study procedures by an authorized site individual and the participant and/or legal representative.
• 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 source documentation and case report forms (CRFs) as applicable.
• Review and sign data management queries and case report forms (CRFs) in a timely manner as applicable.
• Document and explain premature unblinding of the investigational product(s) when necessary.
• Evaluate results and documented findings in participants’ 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.

Knowledge and Skills:

• Possess strong supervision, interpersonal and communication skills.
• Be able to make good, sound decisions under stress and time constraints.
• 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.
• Possess exceptional organizational and planning skills and good documentation skills.
• Have good conflict resolution skills and be committed to quality and honesty.
• Possess in-depth knowledge of the clinical research process, including Good Clinical Practices.
• Ability to think independently and influence when appropriate.

Minimum Requirements

• Fluency in Haitian Creole is a requirement for this position.
• Education : Medical (M.D.) degree, 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.), Doctor of Psychology (PsyD).
• A minimum of 5+ experience in performing physicals, assessing, and treating patients.
• 3+ years' experience within the field of clinical research or biological research is required.

Compensation and Benefits Package

• $125,000 per year
• Paid Time Off
• 8 Paid holidays, Including 2 Floating Holidays
• 401K plan: 4% Match
• Employee Review and Performance Program
• Tuition Reimbursement Policy
• Employee Referral Bonus
• Supplemental Parental Leave

Why Join Flourish Research?

• Be part of a mission-driven organization dedicated to advancing clinical research.
• Opportunity to lead and grow a start-up site with significant impact.
• Collaborative and supportive work environment.

Requirements for Application

• Apply via LinkedIn or send a resume and salary requirements to: executivesearch@highlandperformancesolutions.com
• No faxes or phone calls will be accepted
• Flourish is an equal opportunity employer

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