University of Rochester Human Subject Res Coord II in Rochester, New York
Full Time 40 hours Grade 053 OBGYN Research
8 AM-4:30 PM; OCC WKENDS
Under general direction and with some latitude for independent judgment for the direction and results of the research, collaborates with the Principal Investigator(s)(PI) and the Ob/Gyn Office of Research Administration to operationalize study protocols for multiple NIH and foundation funded studies. The purpose of this position is to coordinate human subject research activities which may include multiple site human subject studies. Ensure all protocols are correctly completed, time frames are met, documentation is correct and complete following all IRB, Good Clinical Practice (GCP), and University rules and regulations as well as those of the sponsor, FDA, and other regulatory bodies. Establish check sheets and post-award workbooks to assure all events within a visit are complete. Maintain equipment in good working order-have instruments calibrated as necessary. Establish safe storage of study equipment. Schedule appointments within the confines of the practitioner’s other duties and the availability of the clinical area. Ensure that all study supplies are available at the site where subject visits are conducted. Contact and schedule subjects, ensuring patient safety and adherence to protocols. Keep current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures and guidelines. Implement and monitor study changes. Demonstrates accountability for continuous learning, industry standards, best practices, and any trends and scientific advances in the fields related to assigned studies.
Study Oversight and Administration:
- Collaborate with the PI to implement and monitor study progress, results, and any issues. Using professional judgment, suggest changes as appropriate to address issues that arise during the study.
- Participate with the IRB to address any issues with the on-going studies, prepare and submit annual reviews, prepare and submit study amendments.
- Manage and schedule study lab work with instructions to the staff and the subjects, report lab results in the appropriate database, and maintain study records.
- Oversee the administration of petty cash, gift cards, or other subject incentive materials.
- Design, create, maintain, and update all study databases as required or oversee staff that do so.
- Create and maintain a Regulatory Binder for each study as well as all tracking documents and other necessary forms for the study conduct and tracking.
- Design and prepare all subject study materials, charts, advertising materials, and subject schedule.
- Represent the study team to IRB, FDA, NIH, University, or other requests for information, audits, or other study queries.
- Develop and maintain good working relationships and support the development of the same with the PI, research staff, study sites, sponsor, and regulatory agencies.
- Set up study equipment, assist the PI with study procedures, clean and maintain the equipment as well as arranging for secure equipment storage.
- Ensure that subjects have all necessary study materials, such as tampons, diaries, pregnancy tests, study drug, drug instructions, and other items as the protocol dictates.
- Contact study subjects as necessary to ensure no adverse effects of study procedures and/or medications.
- Accompany the subject to the OR to obtain samples for specific studies
Financial Oversight of Studies:
- Collaborate with Research Administrator and PI in preparation of the budget. Obtain the cost of lab tests, equipment, and supplies necessary for the study. Conduct investigations to establish minutes necessary for each portion of the study coordinator time and for the PI’s time to assist with budget creation processes.
- Responsible for subject incentive and careful tracking of all subject payments and other incentives.
- Review study expenses such as laboratory charges and supply charges for accuracy and allocability.
Study Set-up and Preparation:
- Submit the initial IRB applications and respond to any changes or revisions requested by the IRB with the PI providing assistance and guidance as necessary.
- Work with administrators and clinic staff to schedule exam rooms for study procedures with minimal disruption of the office schedule if subjects are seen in the clinical area.
- Manage all subject recruitment by reviewing in-patient and out-patient population daily to check for study eligibility, approaching potential subjects, explaining the study, answering all questions, ensuring that subjects meet all inclusion criteria, and obtaining informed consent if they choose to participate.
- Assist the PI in placing advertisements recruiting for the studies in the newspaper, on bulletin boards, etc.
- Converse with potential subjects, review eligibility criteria, answer questions, and schedule appointments. Ensure that any questionable patients are reviewed by the PI before enrollment. If the major recruitment is done by the PI with the coordinator consenting the subject, answer questions and administer the paperwork and questionnaires for the study.
Sample Processing and Shipment:
- Collect, process, and deliver study samples as necessary. When directly obtaining study samples, ensure proper medium, transport, and storage.
- Ship study samples as necessary in accordance with protocols and any applicable laws.Maintain logs and other documents related to the location of study samples and noting when they are used up by analyses.
Bachelor’s degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and related experience. Knowledge of word processing and spreadsheet applications.
Phlebotomy experience highly preferable.
Preferred qualifications: Nursing degree, knowledge of how to manage a clinical research study, familiarity and expertise dealing with patients/subjects, certified Phlebotomist, Certified Clinical Research Coordinator, and familiarity with IRB rules and regulations.
Must be comfortable working with vulnerable populations while being sensitive to research subject/patient privacy and concerns. At all times, must demonstrate the ability to 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. Must work well as part of a team and work independently within scope of practice and minimal supervision from Principal Investigator. Solid computer skills with knowledge of word processing, databases, Excel workbooks, and Outlook. Attention to detail, personal accountability and trustworthiness, ability to work independently and as part of a team, ability to manage and prioritize multiple responsibilities, and commitment to improving the lives of others.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord II
Location: School of Medicine & Dentistry
Job ID: 207196
Full/Part Time: Full-Time