Human Subject Research Spec I

Rochester, NY

GENERAL PURPOSE:

Human Subject Research Specialist I is an entry level clinical research coordinator responsible for coordinating the activities associated with human subject research. They will work under the supervision and guidance of the Principal Investigator (PI) for the particular study. This role will assume responsibility for less complex clinical research protocols, receiving guidance and instruction from senior level roles.

JOB DUTIES AND RESPONSIBILITIES:

Under supervision, coordinates Human Subject Screening Activities, Recruitment and Subject Visits

  • Manage complex scheduling with several time points

  • Reviews study site patient databases and office records for patients that meet the protocol inclusion criteria.

  • Screens potential study candidates.

  • Conduct telephone calls to study subjects

Assists Research Coordinators and PI with study document management and tracking

  • Ensures accurate, confidential, and complete compilation of data.

  • Coordinate and safely complete multiple sequential clinical data collection visits with study participants according to documented procedure, including upload and verification of associated data and data files, ensure post-visit data processing is completed.

  • Collect, maintain, and interpret data associated with study recruitment, utilize electronic medical records as needed, maintain adequate inventory of study equipment and supplies, manage orders for study kits.

Study Maintenance

  • Maintains accurate patient research files and records, according to the University of Rochester and department Standard Operating

  • Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication

  • Responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review.

  • Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits (i.e. pre-study inspection, initiation, on-going and close out visits. Procedures

Complies with Good Clinical Practice (GCP) and Federal Regulations

  • Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, and guidelines

  • Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies and designs.

  • Implements and monitors resulting study changes.

Professional Development

  • Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines

  • Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies

  • Maintains CITI and other trainings/certifications as requires

  • Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols

  • Participates in protocol-related training as required.

Other duties as assigned

QUALIFICATIONS:

  • Bachelor’s Degree required

  • No previous experience

  • OR equivalent combination of education and experience (e.g. an Associate’s degree and completion of 6 months in the Human Subject Research Coordinator Trainee program) required.

  • 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: $20.92 - $29.29 Hourly

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.

Apply for Job

  • Careers

  • Sign In

  • New User

Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
Opening: