University of Rochester Human Subject Res Coord II in Rochester, New York

Opening

Part Time 30 hours Grade 053 Ped Allergy/Immunology-SMD

Schedule

8AM-2PM; SCHEDULE MAY VARY BASED ON OPERATIONAL NEEDS.

Responsibilities

THIS POSITION HAS AN END DATE OF 6/1/21.

Overview:

This position will work under the direction of the Principal Investigators and provide study coordination services for sponsor and government funded research focusing on breastmilk composition and development of the breastfed baby. With broad latitude for autonomy and independent judgment, the HSRC II 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) 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.

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 ICARE* values in each of the major responsibilities.

This position provides lactation counseling and breastfeeding support to research participants. Previous experience with infants is required. Professional breastfeeding support experience is preferred. If not, then applicant must be willing to enroll in Certified Lactation Counselor Training (expenses covered) and pass the exam. Training is held in Rochester, NY from November 12-16; 8AM – 5PM.

This position has very flexible work hours, but availability is needed in morning hours at least 4 days per week to accommodate fasting participant research visits.

Responsibilities:

Study Coordination

  • Independently execute study recruitment – coordination with study collaborators and medical clinics to communicate with potential participants, and enroll subjects into the study
  • Track and ensure that subject enrollment goals are met and all study measures are collected.
  • Maintain rapport and contact with participants, provide study-materials for visits and schedule study visits.
  • Provide breastfeeding support to research participants (as desired) both during and in-between study visits.
  • Direct and conduct the implementation of research study visits. Works with Principal Investigator and research study staff to ensure research visits are conducted smoothly and to minimize participant burden.
  • Collect data at research study visits:
  • Questionnaires
  • Assist in maternal sample collections (including breast milk) and sample processing
  • Infant procedures (ex: feeding studies and anthropometrics), and infant sample collection and processing
  • Writes study manuals and study specific Standard Operating Procedures (SOP’s) which govern procedures and how study will be conducted. Implements SOP’s and ensures adherence to established SOP’s.
  • Maintain protocols and associated documentation such as enrollment forms, eligibility checklists, adverse event reporting forms, and Case Report Forms (CRF), study and regulatory binders for good clinical practice and for sponsor study monitors.
  • Serve as liaison between PI, study site, sponsor and/or governmental agencies. Will be contact personnel for sponsor, regulatory authority, etc. for study related questions/issues.
  • Act as information resource to study staff (PI, other staff within the Division) or sponsor for protocol specific queries. Be able to facilitate answering logistical questions pertaining to these studies such as eligibility questions, which protocols are open and accruing subjects and, knowledge of the status of the protocols.
  • Meet and/or communicate with study sponsors/monitors.
  • With a high level of independence and decision making, makes decisions at meetings on behalf of the Principal Investigator and/or Research Nurses
  • Identify actual or potential study issues, develop problem solutions, and reformulate study goals on an as-needed basis.
  • Order, track and submit appropriate UR forms/documentation for participant incentives/reimbursement, study medications (medication log; as needed), device monitoring (device log; as needed) and study office supplies.
  • Monitor study budget for spending and financial compliance (monitoring of study expenditures). Review study budgets justifications to ensure spending is within budget parameters.
  • Ensure timely and accurate completion of study documents (Informed Consent, Clinical Research Forms, study specific databases) required by study sponsor and regulatory bodies.
  • The maintenance of phone communication (including conference calls and emails with sponsors, departmental, and non-departmental personnel as required concerning study status, enrollment, and study issues/problems) will be instrumental in the sharing and dissemination of critical study information. This sharing of study information will be on a local, regional and national basis.

Data Management/Resource

  • Designs, develops, implements, monitors and manages systems and methods to ensure quality, safety, efficiency and consistency in the processing of data.
  • Reviews study progress, including data, finances, timeframes, documentation and reporting desirables. Manages, implements and monitors systems for tacking and evaluating study progression.
  • Create or utilize data collection forms (based on study), such as chart abstraction form, paper-based or on-line surveys, Case Report Forms. Develop (create) and maintain study-specific databases as necessary.
  • Ensure integrity of all study data collected for eventual publication or presentations at scientific or study sponsored meetings.
  • Create database repository for monitoring study subjects participating in studies or for collating study data. This will be used for study data analysis, sponsor requirements or for study monitor visits. Analyses of data for integrity and reporting of unexpected outcomes to study sponsors. Prepares reports based on analyses as required by study sponsor(s).
  • Review source documentation such as laboratory reports, patient progress notes, etc., and record the results as per individual study guidelines to ensure study data integrity.Ensure timely submission of study data per sponsor/funder requirements.
  • Summarize study results in reports and tables, so that it can be easily understood and disseminated to others. Design, create posters and either present or assist in presenting at study sponsored and scientific meetings, local, regional, national and international depending on sponsor.

Regulatory Compliance

  • Ensure compliance with acceptable regulatory requirements and IRB/WIRB standards. Ensure integrity of all study data collected.Ensure protocol activities are administered consistently across all studies.
  • Will independently submit annual progress reports to the IRB/WIRB in compliance with the specified timelines as required by the UR RSRB Office, from the sponsor or cooperative groups.
  • Independently writes and submits amendments to the RSRB when changes are needed to study procedures and/or measures.
  • Corresponds/interacts with IRB/WIRB on an ongoing basis to ensure that correct procedures are completed in regards to human subject’s research. Primary contact (initial study staff member contacted) between research team and regulatory authorities.
  • Maintains accurate and appropriate regulatory binders for sponsor and regulatory review/site visits.
  • Reviews adverse event reports and/or Action Alerts (alerts from the sponsor for appropriate action to protect subject safety) and to maintain regulatory compliance with UR IRB Office/guidelines. Submit Adverse Event Report to IRB/WIRB to comply with University regulatory compliance.
  • Aid in development and maintenance of appropriate versions of all documents.
  • Prepare for audits through the Institutional IRB/WIRB, study monitor or any other authorized agency. To prepare for an audit he or she will collect all study documents for auditor review and maintain availability to auditor throughout duration of review. Audits/monitor visits are variable depending on sponsor requirements. Visits may be from 1-3 days in duration.
  • Train staff on RSRB/regulatory guidelines and how to utilize University of Rochester RSRB Website and the Western Institutional Review Board (WIRB) Website.

Qualifications:

Bachelor’s degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Knowledge of Microsoft Office programs and data analysis software. Experience with infants and/or breastfeeding mothers required. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) and/or lactation certification (IBCLC, CLC, CLE, La Leche League Leader, etc) desirable. Experience as Human Subject Research Coordinator I preferred. Must have reliable/efficient transportation. Demonstrates desire and initiative to increase knowledge and skills in clinical research. CITI certification required.

Clinical research experience in pediatrics and strong computer skills. Excellent communication skills, telephone skills, and ability to work in a multi-faceted team environment. Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines.

Must possess experience in the area of Research Subjects Review Board (RSRB), Office for Human Research Protections (OHRP) and/or Federal Drug Administration clinical research regulations. Must possess effective communication, organization and decision-making skills as well as maintain accurate and complete records on all subjects. At a local level, this individual must have the ability to devise the necessary strategic methods required to assure the success of the research projects as well as the ability to interact effectively with a wide range of individuals including patients, research nurses, lab personnel, and collaborating clinicians and scientists.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Human Subject Res Coord II

Location: School of Medicine & Dentistry

Job ID: 208255

Regular/Temporary: Regular

Full/Part Time: Part-Time