University of Rochester Human Subject Res Coord I in Rochester, New York
Full Time 40 hours Grade 051 OBGYN Research
8:30 AM-5 PM; OCC WKENDS/HOL
Working closely within a team, provides support at the professional level for a health project involving units within the University and other health facilities and offices within the region to manage the activities for a NIH-funded study focusing on prenatal exposures and infant outcomes. The coordinator is responsible for supporting senior research staff and faculty working in order to reach recruitment and retention goals and ensure the successful conduct of all study activities.
Subject Recruitment and Retention:
Identify and assess subject eligibility, coordinate consents and enroll research subjects for clinical study at all inpatient and outpatient clinic locations served by the Ob/Gyn Department. Coordinate research subject visits involving outpatient study visits; arrange appointments, review protocols, determine eligibility, explain study.
Conduct study visits with enrolled mothers and infants, paying special attention to the specific requirements in each visit type. Track clinic visits of each participant to ensure no collections are missed. Infant assessments will include physical measures and biospecimen collection as well as neurodevelopmental measures.
Working independently, collect and process various biospecimens from study participants in a timely and methodical fashion. Track the processing and storage of biospecimens (including, but not limited to, blood, urine, saliva, placenta). Sample collection will sometimes occur on nights and weekends when births to study subjects occur.
Data Management and Integrity:
Ensure integrity of all study data collected. Enter data into databases, extract data from medical charts and prepare summary reports of data abstracted. Assist team in extracting data needed for presentations and publications. Identify, make recommendations, and resolve data extraction issues.
Other duties as assigned.
Bachelor's degree with major course work in an appropriate health, social or technical field and 1-2 years of related experience; or an equivalent combination of education and experience.
Previous experience with working with women and/or young children strongly preferred. Phlebotomy certification desirable. Familiarity and expertise dealing with patients/subjects is necessary. Assistance with study design, coordination, implementation, operation and evaluation are integral components of the position. Maintaining a working knowledge of the clinical areas under investigation by reviewing research literature, and attending pertinent meetings and seminars. This position may require travel to private medical offices or hospitals in the Rochester areas and to national meetings of the research cooperatives for training.
Must possess effective communication skills in frequent interaction with collaborative clinical Investigators, Coordinators, ancillary staff and numerous departments involved with studies in the department. Work independently with supervision from Principal Investigator and the Senior Study Coordinator. Candidate must be very flexible, able to juggle multiple responsibilities, and take direction. Ensures compliance with acceptable regulatory requirements and IRB standards.
The successful applicant must be adept at communication using electronic media such as text messaging, social media, and on-line interfaces. The successful applicant will also possess great attention to detail and excellent organizational skills as the position will be highly demanding in tracking the subjects and ensuring their compliance as well as in the volume of data to be collected. Excellent telephone skills, knowledge of database, spreadsheet and word processing software (Word, Excel, PowerPoint).
Must have reliable/efficient transportation.
Keeps up-to-date with current federal regulations for conducting clinical studies according to GCP's. Keeps current with industry standards and therapeutic areas relevant to sponsored studies.
Must be willing to maintain a flexible schedule; working on-call including working nights and/or weekends when necessary.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord I
Location: School of Medicine & Dentistry
Job ID: 210747
Full/Part Time: Full-Time