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

Opening

Full Time 40 hours Grade 053 Pediatrics M&D; Neonatology

Schedule

8 AM-5 PM; SCHEDULE VARIES BASED ON OPERATIONAL NEEDS; ABILITY TO CONTACT PARENTS IN EVENINGS AND WEEKENDS REQUIRED.

Responsibilities

THIS POSITION HAS AN END DATE OF 3/31/21

Position Summary:

The Human Subject Research Coordinator provides liaison support at the professional level between health projects involving units within the University and other health facilities within the region involving but not limited to the NICHD (NIH), the Neonatal Research Network (NRN) and the Research Triangle International (RTI-Data Coordinating Center). This position will involve interfacing between the University of Rochester (primary contractor), University of Buffalo (subcontractor) and the Data Coordinating Center. Projects will involve enrolling over 1,500 subjects for a multiyear grants with other NRN Coordinators. The Human Subject Research Coordinator will participate with 15 centers across the country involved in the same studies as part of data sharing, identifying and resolving issues to insure consistency and integrity of data across all centers

Responsibilities:

Identify, assesses subject eligibility, coordinates consents and enrolls research subjects for multiple clinical studies at all inpatient and outpatient clinic locations served by the Division of Neonatology.

Coordinate research subject visits involving outpatient study visits; arranges appointments, reviews protocols, determines eligibility, consenting, explains study.

  • Assess subject response and medical interpretation (as appropriate to scope of practice and with medical providers as back up); identifies areas of concern based on study criteria and makes recommendations for resolution to Principal Investigator.

Coordinate research procedures and interventions and perform health and adverse assessments of research subjects.

  • Supervise application of study technologies or drugs (performed by clinical personnel); ensures all procedure documentation is completed and reviews to identify and resolve areas of concern.
  • Coordinate medical personnel for specimen collection and procedures to ensure medical personnel are following protocol to not compromise research studies. Interventions range from, but are not limited to, drug administration to whole body cooling blanket to administration of inhaled drugs to provision of one type or another of surgical intervention including feeding modifications.

Manage data extraction, data quality and database, prioritizing chart extractions to maximize revenues for studies involving capitation reimbursement by ensuring all required forms to process capitation payments are completed. Identifies, make recommendations and resolves data extraction issues.

  • Assist with manuscript, poster, and abstract preparation as well as for publication or grant requests or the like by preparing data for analysis, interpretations, and reporting.
  • Data extraction from medical record includes interpretation of medical findings to insure findings fit protocol criteria using standardized forms developed by Data Coordinating Center.
  • Analyze and interpret selected data points, involving approximately 50 to 100 data points depending on study, based on protocol definitions, ensure integrity of data collected reflects protocols.
  • Identify data collection issues; makes recommendations and advises Senior Human Subject Research Coordinator, subject matter experts, or site investigators to resolve issues. Resolution may involve interfacing with Data Coordinating Center or with NIH.
  • Conduct quarterly quality control analyzes of work performed by other Coordinators including University of Buffalo subcontractor to insure data collected follows protocols

Assist Faculty-Investigators with the planning, development and implementation of study designs, data collection tools, protocols, and consents for multiple site clinical trials across various therapeutic areas according to regulatory requirements. Tracks study documents.

Ensure integrity of all study data collected. Ensures protocol activities are administered consistently across studies.

  • Work with Regulatory Agencies, including IRB, Pediatric Clinical Research Office, Office of Human Subjects Protection; works with Clinical Research Center. Documents and reports regular and adverse events.
  • Assist with grant preparation, writes amendments to IRB protocols, prepares IRB applications, assist with preparing IRB protocols.

Coordinate maintenance of multiple study budgets, review of budgets, budget allocations to ensure revenue, variances and encumbrances are documented. Prepare data for budget requests and financial reports assisting Principal Investigator and Pediatric Research Finance Office. Coordinate expenditure controls. Tracks honoraria and study expenses

Serve as liaison between NRN, University of Buffalo (subcontract), sponsoring and governmental agencies facilitating communication and relaying data based on analyses and progress of studies.

Participate in Teleconferences twice monthly – involving data sharing, assessing progress, project planning, troubleshooting and resolving issues within Division of Neonatology (intracenter).

  • Participate in monthly Coordinator Teleconferences with Data Coordinating Center involving data sharing between University of Rochester, University of Buffalo and 15 external centers in same project studies across the country (intercenter). Teleconferences will include identifying, troubleshooting and resolving data collection issues to insure consistency and integrity of data across all sites conducting same studies.
  • Participate in quarterly quality control meetings with includes project status and enrollment. Will include site visit to University of Buffalo to review data collection activities as part of quality control to insure integrity of study.
  • Arrange site visits and oversees site visitors, prepares data for site reviews, resolves issues identified by reviewer(s).
  • Represent study at Quarterly Steering (Coordinator) Committee meeting in Washington DC with all 17 Centers throughout the country involving 20 to 25 sites to participate in discussion, represents PIs at coordinator meetings, and disseminating information from the quarterly meetings to Rochester and University of Buffalo teams. Studies, interventions, and data collected are reviewed and discussed to optimize enrollment, ensure consistency among sites and ensure procedures done similarly, appropriately and safely.

Serve as backup to other Coordinators to ensure all studies are managed and completed in a timely manner.

Qualifications:

Bachelor’s degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Knowledge of word processing and data analysis software. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. Experience as Human Subject Research Coordinator is preferred.Certified Clinical Research Coordinator and/or nursing degree desirable/preferred. Phlebotomy certification desirable.

The successful candidate will be responsible for implementation of multiple study protocols, identifying and enrolling research subjects, acting as an educational resource for research subjects and their families, coordinating specimen collection, collecting clinical data, and analyzing data. Familiarity and expertise dealing with patients/subjects is necessary. Assistance with study design, coordination, implementation, operation and evaluation are important components of the position, and may be dependent upon previous experience. A willingness to learn and add these skills is essential. Maintaining a working knowledge of the clinical areas under investigation by reviewing research literature, and attending pertinent meetings and seminars will be required. On occasion, this position may require travel to private medical offices or homes in the Rochester area, to Buffalo for cooperative group meetings and to national meetings of the research cooperatives for training. The successful candidate must possess effective communication skills due to frequent interaction with collaborative Clinical Investigators, Coordinators, Ancillary Staff and numerous departments involved with studies in the University. The successful candidates will be expected towork independently within scope of practice, with minimal supervision from Senior Human Subject Research Coordinator and Principal Investigators. While the candidate must be a flexible independent thinker, they must be able to work as a member of the research team. The candidate must ensure compliance with acceptable regulatory requirements and IRB standards.

Excellent telephone skills, knowledge of database, spreadsheet and word processing software (Microsoft Word, Excel, PowerPoint) is essential. The candidate must have reliable/efficient transportation. The successful candidate will be required to keep up-to-date with current federal regulations for conducting clinical studies according to GCP’s, and keep current with industry standards and therapeutic areas relevant to sponsored studies.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Human Subject Res Coord II

Location: School of Medicine & Dentistry

Job ID: 210104

Regular/Temporary: Regular

Full/Part Time: Full-Time