Sr Human Subject Research Spec - Ped Allergy

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

601 Elmwood Ave, Room 48104, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:
Regular

Time Type:
Full time

Scheduled Weekly Hours:
40

Department:
400200 Ped Allergy/Immunology-SMD

Work Shift:
UR - Day (United States of America)

Range:
UR URG 110

Compensation Range:
$61,000.00 - $85,400.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

The Senior Human Subject Research Specialist will work with minimal direction of the Principal Investigator and provide study coordination services for complex sponsor and government funded research involving newborns, infants, children and their families. With broad latitude for autonomy and independent judgment, the Senior Specialist is responsible for implementation of study protocols, identifying and consenting research subjects, acting as resource for research subjects and their families, supervising study visits at the Clinical Research Center (CRC), clinical areas, and home-visits, collecting data at study visits, and maintaining study database. The position will be expected to organize multiple projects, allocate resources, monitor progress, and meet multiple deadlines. Coordinates, monitors, and oversees all phases of complex grants (NIH and other agencies). There is potential for travel to investigator meetings and conferences. Responsibilities will include but not limited to training and managing study staff, regulatory and fiduciary oversight, and representing the Principal Investigators in their absence.

Work on an independent level, making primary decisions related to research specific implementation. Work collaboratively in the development of research protocols and consents. Maintain appropriate IRB (RSRB or WIRB) approval and documentation. Provide knowledge and skills to successfully maintain proper study activities. Maintain continuous relations with study team and principal investigator. Demonstrate ability to develop and maintain good clinical practice, division goals and objectives and utilize expert skill and knowledge to deliver safe and thorough research subject care. Demonstrates IICARE values in each of the major responsibilities.

ESSENTIAL FUNCTIONS
Human Subject Recruitment & Management

- Direct the comprehensive process of subject recruitment, screening, enrollment, and follow-up for complex clinical studies, including targeted recruitment strategies, eligibility assessment via electronic medical record (EMR), and ensuring participant comprehension and compliance with study protocols and Good Clinical Practice guidelines.
- Oversee and manage subject enrollment logistics and progress across all studies, ensuring recruitment targets are met and all necessary study measures are collected efficiently.

Research Study Coordination

- Serve as the central liaison for all study-related communications, facilitating effective information exchange between investigators, regulatory bodies, sponsors, and various internal and external departments, while also leading multi-site study implementation, start-up, and ongoing maintenance.
- Direct the development and implementation of study protocols, visit flows, source documents, and databases, ensuring data quality through rigorous review processes and setting clear deadlines for data collection and entry by study staff.
- Utilize clinical judgment to review laboratory results and adverse events, acting as a primary clinical triage point when PIs are unavailable, and prepare comprehensive analytic reports and data summaries for sponsor/FDA submissions, publications, and presentations.
- Develop and enforce systems to ensure strict staff accountability for protocol adherence, timely completion of tests, and accurate data and specimen collection, while also leading site monitoring visits and assisting in grant proposal reviews.
- Direct and conduct the implementation of research study visits, including performing clinical assessments, consenting and enrolling subjects, preparing biologic specimen kits, performing research-related tests and procedures, obtaining specimens (blood, swabs, saliva, urine and stool, breast milk), collecting medical information, and completing study data forms and data entry. Provide breastfeeding support to research participants (as desired) both during and in-between study visits. Ensure research visits are conducted smoothly and to minimize participant burden.

Regulation & Compliance Management

- Manage and monitor all aspects of Institutional Review Board (IRB) submissions, including applications, amendments, and annual reports, ensuring timely and accurate preparation of regulatory documents for submission to sponsors, FDA, and various regulatory agencies (e.g., WIRB, RSRB [UR Research Subject Review Board], GCPC, NIH).
- Develop, revise, and oversee the implementation of study protocols, designs, recruitment materials, and consent forms, establishing robust quality control measures to ensure data accuracy, reliability, and comprehensive compliance with all regulatory and ethical guidelines.
- Act as the primary regulatory liaison, communicating guidance and compliance information to study staff, ensuring proper version control of all study documents, and preparing staff for audits by Pediatric Clinical Research Office (PCRO), IRB, and study monitors, while also initiating and managing Material and Data Transfer Agreements and Research Contracts.
- Oversee all study adverse events, and submit accurately per timeline(s) required by Sponsors and the IRB.

Finance

- Manage and analyze study budgets and expenditures, reviewing monthly financial reports to assess cost factors, advise PIs on spending distribution, and ensure financial compliance through meticulous account ledger analysis and appropriate charge allocation.
- Oversee the financial aspects of study services, including developing invoices for sponsor reimbursement and ensuring accurate billing and compensation receipt, while collaborating with Pediatric Finance to communicate and enforce departmental, IRB, and sponsor financial requirements to study staff.

Supervision

- Provide comprehensive training, mentorship, and daily oversight to new and existing study staff and student workers, monitoring their progress, identifying strengths and weaknesses, and optimizing their contributions to study work.
- Manage the day-to-day operations of study personnel, addressing personnel issues, identifying training needs, and making recommendations to PIs for resolution, while also providing critical feedback for annual performance reviews. Develop systems to hold study staff accountable to protocol specifics.
- Actively participate in the interview and hiring process for research coordinator staff and student workers, advising PIs on divisional research needs, and regularly conduct meetings with staff to review progress, address concerns, and foster a collaborative research environment.

Other duties as assigned

MINIMUM EDUCATION & EXPERIENCE

- Bachelor's degree and 5 years of experience in human subject research coordination required
- Or equivalent combination of education and experience
- Experience as a Phlebotomist preferred

KNOWLEDGE, SKILLS AND ABILITIES

- Word processing and data analysis software required
- Ability to devise the necessary strategic methods strongly preferred to assure the success of the research projects, including document creation/editing, data analysis software
- Excellent organizational and communication skills strongly preferred
- Expertise in the areas of Research Subjects Review Board (RSRB), Office for Human Research Protections (OHRP) and Federal Drug Administration (FDA) clinical research regulations. Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes strongly preferred.
- Reliable/efficient transportation for travel, locally, regionally and nationally as needed strongly preferred
- Ability to interact effectively with a wide range of individuals, including infants, parents/pregnant people, peers, clinical researchers at all levels, and the general public strongly preferred.
- Supervisory experience preferred
- Clinical research experience in pediatrics and/or experience as a Human Subject Research Coordinator II preferred
- Experience with infants and/or breastfeeding mothers preferred

LICENSES AND CERTIFICATIONS

- SOCRA - Certification In Clinical Research upon hire preferred
- Association of Clinical Research Professionals (ACRP) upon hire preferred
- CITI - GCP and HSP preferred
- Dry Ice Shipping preferred
- Basic Life Support preferred

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