University of Rochester Project Nurse in Rochester, New York
Full Time 40 hours Grade 044 OBGYN Research
8 AM-4:30 PM; WKENDS/HOL
- Initiate, maintain, and monitor contact with study participants, including obtaining informed consent
- Collect study data (behavioral, biological, interview, medical record) accurately and completely
- Maintain and foster relationships with a multi-disciplinary research team and with hospital and clinic staff
- Direct and facilitate communication across research sites and with funding agencies
- Provide leadership for and supervision of research staff
- Manage administrative and data collection responsibilities
The post is for an advanced and experienced research nurse to join a research project that will be tracking mothers from the first trimester through the child’s 4th birthday. The project includes collecting psychosocial, psychological, behavioral, biological, and medical record data on mothers and babies on multiple occasions throughout the study period. The research takes place at the Strong and Highland hospitals and affiliated clinics, as well as at the Clinical Research Center and the Rochester Center for Brain Imaging. The post assumes significant independence. Supervising other research staff and monitoring regulatory compliance will be required. Core responsibilities will be on maintaining positive relationships with study participants, conducting research visits, collecting high-quality data, recording and maintaining record-keeping related to data collection, and liaising with research staff and diverse team of collaborators. Occasional weekend or evening work will be required.
Initiate and maintain relationships with study participants:
- Assemble, update, and maintain study packets, including consent, inclusion/exclusion check lists, contact information and other essential study information
- Screen potential study subjects and obtain consent on interested and eligible participants
- Maintain updated study participant records throughout the study period
- Maintain positive relationships with study participants to ensure high retention rates throughout the study period
- Disseminate information about the study to others in clinical setting and community
Conduct research visits and oversee data collection:
- Lead and direct research visits in the prenatal and postnatal period
- Supervise research staff in the collection of psychosocial, psychological, behavioral, biological, and medical record data
- Maintain updated data collection protocols
- Ensure updated data collection records and compliance with established research protocols
Oversee regulatory compliance and data quality:
- Manage studies to prevent protocol deviations
- Employ electronic and paper case report forms to ensure accurate recording and reporting of data collection
- Ensure that all necessary data are collected and recorded in appropriate source documents and case report forms
- Provide source documentation for all study data
- Prepare regulatory documents for submission to RSRB, WIRB, ORPA, and Sponsor.
- Respond to data clarification requests in a timely manner
- Maintain confidentiality of PHI and keep all study records secure
- Monitor subjects for adverse events and inform PI and IRB as required and, in conjunction with PI, report serious adverse events (AE) to study sponsor and regulatory personnel within required timeframe.
Administrative responsibilities to ensure:
- Attend research meetings as required
- Assist in training new study coordinators
- Manage laboratory procedures, samples, processing, packaging, supplies and shipping
- Ensure all regulatory documents and correspondence is submitted to regulatory personnel in a timely manner
- Problem solving, related to any study issues that may arise.
- Manage subject reimbursement, track petty cash, manage distribution of parking vouchers
- Other duties as required by study PI
Successful candidate will be a graduate of accredited school of nursing and licensed in New York State as a Registered Nurse.
The post requires an ability to work independently and proficiently with minimal supervision in a busy clinical research setting. The successful applicant will be comfortable working with vulnerable populations and able to be sensitive to research subject/patient privacy and concerns. At all times, must interact with all staff of all levels in a professional and positive manner, including verbal and non-verbal communications in person, by phone, over the internet, or in correspondence. Also required is an ability to work well as part of a multi-disciplinary team. Solid computer skills with knowledge of word processing is required, as is awareness of guidelines related to clinical research, including HIPAA and RSRB, as well as lab safety regulations. Flexibility in working hours, to include occasional weekend or evening hours, will be required.
Core competencies include knowledge of the rigor of clinical research and the application of research protocols for collecting psychosocial, biological, and other data in a research laboratory and hospital setting. Proficiency with EMR, electronic database management, and basic processing of biological specimens is also required. Maintaining professional memberships and certifications is also expected.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Project Nurse
Location: School of Medicine & Dentistry
Job ID: 203535
Full/Part Time: Full-Time