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Join a rapidly growing team that is a global leader in clinical trials! Re:Cognition Health, a leading provider of clinical trial research specializing in cognitive impairment, is looking for a bright, caring and highly motivated Sub Investigator (SI) for its clinical trials. Re:Cognition Health’s clinics are major centers for international trials of disease-modifying drugs for Alzheimer’s disease and other neurological conditions.   

The Sub Investigator has responsibility for the clinical safety of the patients partaking in the clinical trial, collecting and recording accurate clinical data while also ensuring that the well-being and interests of the subjects enrolled in the studies are being met. The SI provides essential clinical support to the Center Managers, Coordinators, Principal Investigators, and other clinical trials staff. 

The ideal individual is a dedicated clinical practitioner with experience in cognitive and/or neurological diseases and clinical research.  This is a part-time position for now, with 3 days per week working in the clinic from circa 10 am to 4 pm.  Unique opportunity for individuals looking for a more flexible schedule while working with a cutting-edge clinical research team.

JOB RESPONSIBILITIES: 

•  Perform the clinical study in accordance with ICH GCP, ensuring that adequate time and resources are available, as described in the trials’ protocols 
• Clinically evaluate study participants, answer their medical questions, and resolve medical issues, related to the clinical trial during study visits  
• Maintain records of each subject’s participation, which includes a review of participants’ past and current medical records, to be compared with visit medical history, concomitant medication and protocol inclusion and exclusion criteria. 
• Determine participant’s eligibility for the study
• Assessment of subject response to therapy and subject compliance with use of the study drug at follow-up visits
• Administration of in-site study drug, including IV drugs, SC drugs and oral medications. 
• Clinical evaluation and treatment of subjects for adverse events and reporting of all such events to the PI or study coordinator, according to protocol
• Ensure medical care is provided (or made available) to subjects for any treatable adverse event
• Monitor use of concomitant therapy as authorized by the study protocol
• Ensure that study drugs and devices are used for protocol purposes only
• Provide leadership in identifying new clinical trials and assist in initiation of new trials
• Play an active role in the doctor-led recruitment of patients to designated studies, while ensuring that subject recruitment is conducted ethically and efficiently
• Participate in pre-screening recruitment initiatives and activities for clinical trials participants, including presentations to healthcare professionals, public screening clinics, etc, as required.
• Comprehensive understanding of the informed consent process and protocol so that proper written informed consent from each subject is received prior to participation in the study
• Partake in Company Governance, FDA, Sponsor and CRO monitoring visits
• Completion of all administrative tasks for patient files according to GCP guidelines and best clinical practice 

REQUIREMENTS: 

• MD, DO or foreign trained medical doctor, licensed to practice in Virginia
• Act in a professional and caring manner towards patients, visitors, and colleagues, projecting a high quality and high service experience 
• High ethical standards in line with company policies and procedures
• Self-starter able to plan and prioritize own workload
• Work collaboratively with colleagues to deliver services effectively and efficiently
• Must undertake all training and certification required by Pharma to carry out clinical trials within specified timelines.
• Attention to detail
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements
• Excellent communication skills