University of Rochester Human Subject Res Coord I - 224294 in Rochester, New York
Human Subject Res Coord I
School of Medicine & Dentistry
Full Time 40 hours Grade 051 Med M&D-Pulmnry/Crit Care Unit
Coordinates and oversees human subject research activities and clinical trials involving government, industry-sponsored, and investigator-initiated studies in Pulmonary Hypertension. Under general direction, the Incumbent is responsible for recruiting and screening research subjects, scheduling studies, performing 6-minute walk tests with sensors, managing Actigraph and MC10 devices, and downloading data into a database.
Supervision and Direction Received: Under general direction and with some latitude for independent judgment, incumbent will interact with the Principal Investigators and Staff Scientist on an individual basis on various studies.
Machines and Equipment Used: Computer proficiency specifically with MS Office and Excel are necessary. Having a basic understanding of wearable technology will be needed. The two devices currently used are MC10 Biostamp nPoint and Actigraph.
TYPICAL RESPONSIBILITIES & DUTIES:
Oversees and coordinates clinical research studies evaluating wearable technology in pulmonary hypertension. This entails reviewing clinic schedules weekly to look at upcoming potential subjects’ appointments.
Sets up visits per the protocol and ensures all necessary equipment available. This requires good understanding of the research study requirements and use of independent decision-making and assessment skills.
Determines what patients may be eligible to participate in, explains the details of the study to the subject and has them consider consenting.
Assists with primary data collection for the clinical research studies. Data will be obtained from the electronic medical record and imported into a HIPAA compliant server. Coordinates and performs research subject visits. Data obtained from the MC10 Biostamp and Actigraph will need to be collected and imported into a database. Data quality will need to be evaluated after each use.
Ensure compliance with all applicable regulatory and institutional requirements and standards. Ensure the integrity and security of all study data at all times. Initiates, monitors and ensures that all protocol activities are standardized across studies. Ensures that all documentation is maintained according to industry sponsor requirements, and IRB (local or central) regulatory guidelines. Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keep current with industry standards, best practice, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.
REQUIREMENTS (Education, Experience, License or Certificates):
Bachelor’s degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Proficiency in computer software applications including Microsoft Office programs such as Excel, Outlook, and Word. Ability to learn and master existing department applications and future software applications and programs. Excellent communication, interpersonal and organizational skills; highly persistent and energetic professional style; self-motivation and drive to reach goals/objectives. Strong attention to detail, ability to digest and understand the study, and the strong ability to use good judgment in assessing each individual’s comprehension.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled