About the Job:
We are actively hiring a Sub-Investigator to support our Ravenswood site in Chicago, Illinois.
Shift: Monday-Friday day shift (40 hours per week)
Location: Onsite, Chicago, IL
FLSA Classification: Exempt
PURPOSE: 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.
ESSENTIAL JOB FUNCTIONS:
• 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.
• 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 study-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 article 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.
• Obtain 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.
• Document that informed consent has been obtained from the participant or legal representative.
• Always consider participant safety and welfare the priority.
• 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.
Requirements
PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:
• Work is normally performed in a typical interior clinical/office work environment.
• Participant Care
MINIMUM REQUIREMENTS:
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).
Experience: 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 preferred; however, is not required.
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.
Benefits
Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.
