Human Subject Res Coord II

Opening

Full Time 40 hours Range URG 108 Medicine M&D-Immuno/Rheum Div

Schedule

8 AM-5 PM

Responsibilities

GENERAL PURPOSE:

Using knowledge of Good Clinical Practice standards coordinates, develops, plans, implements, and monitors systems and methods related to human subject research activities. This individual will have responsibility for overseeing administrative processes related to human subject research and the recruitment, enrollment, and follow-up of volunteers meeting regulatory, University and sponsor requirements for the projects. May supervisor others.

RESPONSIBILITIES:

• Develops, plans, and implements protocols and study design(s) by developing, planning and creating source documents and tools that comply with regulations and requirements by using expert knowledge of IRB, GCP, FDA, Sponsor and University requirements. Ensures completion of all regulatory, qualification and feasibility documentation to ensure site selection and timely start-up of studies.

• Oversees and coordinates human subject research activities. Uses critical thinking skills and problem-solving skills to execute protocols and ensure compliance with the schedule of events.
  
  Plans and coordinates with subjects, investigators, efficacy and safety assessors, lab staff, drug administration and education staff to schedule study visits and procedures within allowable windows. Manages study supply inventories, reviews provider and staff schedules, room utilization schedules, and works with outside departments for ancillary testing and/or procedures to ensure appropriate resources are available to carry out study visits and procedures. Conducts subject visits and evaluates subjects' continuing eligibility for study participation by identifying and documenting subjects' changes in health; notifying PI of safety or efficacy concerns and making recommendations regarding subjects' continued participation by using good clinical practices and expert knowledge of the protocol.
  
  Collects, documents, interprets and manages data by performing chart review, conducting interviews, administering questionnaires, maintaining specimen results, reviewing and documenting changes in concomitant medications, and reviewing and documenting changes in adverse events including serious adverse events. Maintains complete, accurate, and applicable information to ensure data integrity.

• Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression. Enrolls subjects in clinical trials by participating in the informed consent process; enrolls subjects in non-drug clinical studies by obtaining informed consent.
  
  Obtains re-consent. Serves as the primary contact for subjects during entire clinical trial or study. Interviews subjects to determine if they have experienced health changes that should be reported as adverse events.
  
  Adjusts questioning based on subjects' responses. Administers questionnaires as appropriate. Reviews concomitant drugs.
  
  Assesses compliance with protocol and counsels non-compliant subject obtains vital signs. Collects and processes biologic samples. Transports and/or ships samples to the research lab, local and/or central clinical lab ensuring that specimens are received and processed in a timely manner.

• Develops, implements and evaluates recruitment strategies, information and data systems and study management systems to ensure recruitment targets are met. Gains knowledge and understanding of allergic, immunologic and/or rheumatologic diseases, including disease classification criteria and disease activity indices.
  
  Performs screening activities to identify potential study subjects. Interprets data in the electronic medical record (EMR) and historical documentation from outside providers to evaluate subject eligibility. Communicates with potential research subjects in a timely manner and in accordance with good clinical practices.
  
  Assesses subject's ability to comply with the study protocol(s), and willingness to participate freely. Assesses subjects' understanding and comprehension of the study requirements and their participation in the study.

• Coordinates and monitors financial data. Ensures complete and accurate reimbursement from Sponsors by reporting invoice-able procedures to finance team(s) and reconciling Post Award Workbooks with finance team. Determines appropriate funding when procuring study supplies, making subject payments, and approving study charges including determining if a charge should be billed to standard of care or research. evaluates processes and identifies and implements opportunities to use resources more efficiently to support the University's LEAN initiative,.

• Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, prepares, organizes and maintains documentation for study sponsor and regulatory agencies by monitoring expiration dates, study site changes, and protocol amendments to ensure compliance with the protocol(s), contract(s), federal and ICH guidelines. Reviews and makes changes to centralized sponsor forms and obtains sponsor approval for such changes to ensure site-specific requirements are met. Completes continuing reviews and progress reports by collecting, analyzing and interpreting data.

• Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subject studies. Validates study endpoints and communicate study data to the PI, lab personnel, and/or sponsor, assesses and interprets which specific data collected on source documents is appropriate to compile and transfer into a database or into sponsor Case Report Forms (CRFs). Plans, develops and implements security controls for electronic and hard-copy research data to ensure HIPAA regulations are followed by

• Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Provides training to ensure Principle Investigator(s) is(are) meeting responsibilities with respect to human subject research, provides training for study staff, tracks safety report review, and communicates with study sponsors, monitors IRB, FDA and other regulatory agencies. Represents the University and the Principle Investigator at appropriate meetings regarding clinical research projects.

QUALIFICATIONS:

• Bachelor's degree required.

• 3 years of experience in human subject research coordination required.

• or equivalent combination of education and experience required.

• Experience as Human Subject Research Coordinator I preferred.

• Word processing and data analysis software preferred,

• Professional Research Coordinator certification (SoCRA or ACRP) preferred.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University's mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $ 50,752 - $ 71,053 Annually

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.