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University of Rochester Human Subject Res Coord I - 217168 in Rochester, New York

Human Subject Res Coord I

Job ID

217168

Location

School of Nursing

Full/Part Time

Full-Time

Favorite Job

Regular/Temporary

Regular

Opening

Full Time 40 hours Grade 051 SON Staff/Research Programs

Schedule

8:30 AM-5 PM; SOME WKENDS

Responsibilities

Position Summary:

This position will contribute effort to an ongoing NIH-funded study conducted in Rochester, NY—the Women’s Study in Sexual Health and Empowerment (WISE) (R01MD013553). The WISE study seeks to understand barriers to the use of the HIV prevention medication known as Truvada (HIV pre-exposure prophylaxis or “PrEP”) among women of color. The study employs an observational cohort design in which participants are enrolled in the study then return for follow-up assessments every 3 months for 12 months (5 study visits in total). These repeat assessments consist of a health survey and biological sample collection. The project is conducted with both English and Spanish first-language speakers. Agency-based recruitment activities and participant enrollment and data collection will take place at various locations throughout Rochester, so the position will involve extensive travel within Rochester.

Responsibilities:

  • Plans and conducts activities to increase awareness of the study among potential participants, and to locate, recruit, enroll, administer baseline and follow-up assessments with eligible participants, most of whom are from racial-ethnic minority or low-income communities. Some participants will be recruited through primary care clinics, governmental or other agencies, community based organizations or community venues, but because potential participants may be (a) engaged in illegal or stigmatized behavior (such as illicit drug use, drug selling, panhandling, theft, and sex work), (b) have illegal status in the U.S., and/or (c) have co-morbid mental health conditions, many tend to be hidden from health services and must also be recruited directly through community engagement. These characteristics of the study populations also make study retention and data collection challenging, requiring sound independent judgment based on experience and training in order to sensitively and effectively deal with issues related to discrimination, stigma, illegal behavior, drug addiction, mental health issues, domestic violence, and isolated street situations.

  • Plans and implements outreach activities and serves as liaison between the WISE project and area clinics, agencies, and community based organizations.

  • Manages, maintains, and ensures data quality and safety for multiple information systems critical to the operations of the studies.

  • Coordinates and maintains an active internal study: HIV Study Re-contact Database (RSRB STUDY00001847).

  • Able to perform all research-related activities in fluent English and Spanish languages, both written and verbal.

Plans and Implements Recruitment Strategies

Responsible for planning, implementing, evaluating and adapting recruitment strategies for the WISE project. Manages multiple information systems containing data on various recruitment, enrollment, and data collection protocols. Contributes to the planning and operational execution of study design, protocols, consent forms, processes and policies. Contributes to the development and reporting of case report forms (CRF) to document new HIV diagnoses among active participants, and procedure manuals and documents.

Ethnographic Mapping. Coordinates and conducts ethnographic mapping prior to community recruitment to identify locations characterized by activity of the study populations and venues catering to women at high risk for HIV.

Street Recruitment. Plans and conducts community-based recruitment in order to locate, approach, screen and recruit high-risk HIV-negative women from community venues in Rochester, NY. This task requires experience in outreach and networking, and knowledge of community culture.

Clinic/Agency Recruitment. Supplies recruitment materials to support passive and referral recruitment activities at health clinics/centers and other service agencies and organizations. Passive recruitment involves distributing study recruitment materials such as posters and pamphlets; referral recruitment involves facilitating providers/service members to refer their patients/clients to the studies.

Liaison between WISE Project (University of Rochester) and External Agencies

Serves as the primary representative and liaison of the WISE project when communicating and interacting with external clinical sites, service agencies, and community based organizations that engage in passive and referral recruitment activities involving human subjects research. Responsible for positively and effectively representing the University/WISE Project in communication with clinical providers, and other external organizational service providers involving study-related matters. These providers and agencies assist with participant recruitment by distributing study flyers, posters, and other recruitment materials to their patients/clients. Coordinates and monitors, via an information system, all contacts (emails, phone calls, site visits) with external agencies. Plans and implements strategic communication with such agencies and conducts site visits; responsible for maintaining agency supply of study materials.

Human Subjects Enrollment and Data Collection

Contributes to the development or modification of recruitment and enrollment strategies. Responsible for overseeing enrollment of participants into the study and coordinating and managing the appointment scheduling process and information system for participant research appointments for enrollment, baseline, and follow-up visits. Conducts data collection activities, which include oral swab HIV testing, dried blood spot (finger prick) collection, administration of an electronic health survey, and HIPAA authorization to obtain medical record data.

Participant Enrollment. Conducts in-person participant eligibility screening and administers informed consent protocols. Obtains consent by providing clear description of the scope and nature of the study including potential risks and methods to mitigate risks. Separate consents are obtained for HIV testing, and HIPAA authorization to release participant medical records. This task requires knowledge and training in the protection of human subjects including rendering independent judgment based on experience about subjects’ capacity to provide informed consent and perform study tasks.

Quantitative Interview/Survey. Conducts quantitative structured interviews (computer assisted surveys) with study participants. Probes for complete and accurate responses during the interview process; clarifies intent of participant responses, and fields questions regarding the meaning of survey items. Patiently instructs participants on the use of the computer-assisted self-interview portion of the quantitative survey. Adheres to strict ethical standards of confidentiality of subject information. This task requires knowledge of street language and experience on how to manage participants who may become agitated, emotional, belligerent, uncooperative, or suffer from mental health co-morbidities and addictive behaviors.

Biological Specimen Collection. As needed, performs oral swab HIV screening test with participants using the Ora-Quick Rapid HIV Test Kit. Requires training and experience administering this screening test. As needed, perform finger-stick blood spot collection for dried blood spot (DBS) assay analysis, which measures the level of PrEP medication in the blood as an objective measure of medication adherence. Requires training and experience in administering DBS blood collection, including universal precaution protocols.

Participant Payment. Distributes compensatory payments to participants for site visits.

Contributes to Assurance of Data Quality and Safety

Manages four databases:(i) provider/agency communication, contacts and supply database, (ii) follow-up locator information database, (iii) participant appointment scheduling system, and (iv) coupon-based peer referral database. Monitors these databases for quality and safety (compliance with HIPAA security protocols), and corrects or reconciles inaccuracies and inconsistencies.

Ensures Regulatory Compliance

Ensures compliance with all federal, state, local and institutional regulatory compliance, requirements and standards. Under general direction from the PI, ensures that project staff are trained on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion, and adverse event reporting.

Administers Participant Service Referrals

Recognizes signs and symptoms that require participant intervention or referrals (passive or active) to health and social services including substance abuse treatment, HIV/AIDS clinical care, mental health treatment, suicide prevention, antisocial behavior, domestic violence, or child abuse. Performs appropriate referrals as needed. Maintains and updates a listing of approved health services for referrals.

Report Preparation including Adverse Event Reporting

Works with the Principal Investigator to prepare monthly reports on subject screening, enrollment, and completion in the study. This includes memos and regular communication with the PI to recommend changes to study protocols to improve research quality or human subjects’ protections. With guidance from the PI, but applying independent judgement, observes, recognizes, and reports all incidents of adverse subject events associated with the study.

HIV Study Re-contact Database

Contributes to the ongoing development of and coordinates and maintains an active database for re-contacting former study participants and informing them of any new studies for which they may be eligible. This protocol is considered an independent study separate from WISE—HIV Study Re-contact Database (RSRB STUDY00001847).

Ongoing Training and Education

Upgrades and increases skills and expertise by attending training sessions and keeps current with the literature on HIV/AIDS treatment and lifestyle issues (e.g., stigma and discrimination associated HIV/AIDS), drug treatment, mental health co-morbidities, interviewing and referral techniques and working with underserved and vulnerable populations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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