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

Opening

Full Time 40 hours Grade 053 Psychiatry M&D; Research

Schedule

8 AM-4:30 PM; OCC EVENINGS

Responsibilities

Overview:

This is a full-time position for the next 5 years as an essential member of the Getting Active Project (GAP) research study, which is funded by the National Institute on Aging (NIA). Under general guidance with latitude for exercise of independent judgment, the Clinical Research Coordinator (Lead CRC) will oversee and supervise the daily operations to ensure the scientific integrity of a randomized trial comparing two interventions-volunteering and life review-among adults age 60 and older who report loneliness. All subjects (n=300) will participate in active psychosocial interventions for one year, with repeated assessments of psychosocial functioning, health, and well-being (assessments by CRC Assessor). The volunteering condition is an existing program through our community partner, Lifespan (an aging services agency). However, Lifespan staff are not trained in research design and methods and require on-going supervision and monitoring to ensure the scientific integrity of the study.

Subjects assigned to volunteering will serve as peer companions for frail, homebound older persons for one year (these individuals are not research subjects), for approximately 4 hours per week. Subjects assigned to the life review condition will complete monthly writing exercises that examine themes in their lives, with email support from a study interventionist (CRC Interventionist). Subjects will be recruited primarily through the Greater Rochester Practice Based Research Network (PBRN), which is a network of URMC (and outside) primary care practices that are willing to consider involvement in research.

Specific Responsibilities:

Project Administration:

Directs the planning, implementation, coordination, operation, and evaluation of the two study interventions (life review and volunteering) to ensure scientific integrity of the study and maintain subject well-being and safety.

  • Supervise and coordinate the implementation of both study interventions, including daily interactions with our community partner (Lifespan) and daily supervision of the study staff member who is administering the life review intervention.Coordination with our community partner, Lifespan, requires knowledge and skills regarding community-based research and navigating complex systems; the Lead CRC will need to exercise independent judgment regarding partnership maintenance and growth.
  • Establish systems for monitoring intervention fidelity for two complex psychosocial interventions. This entails daily contact with Lifespan staff to provide education and supervision in research design and methods to ensure the scientific integrity of the study. The CRC will guide and supervise Lifespan staff.
  • Provide professional direction, guidance and leadership in the planning and delivery of the interventions and monitor efficiency while promoting retention of study subjects.
  • Ensure open and direct communication with members of the GR-PBRN and Lifespan staff.
  • Manage study regulatory files and ensure all staff complies with IRB regulations and NIH regulations, including ethical treatment of human subjects.
  • Determine study protocol changes and events requiring RSRB review; complete relevant forms and follow up with RSRB until approval or other appropriate resolution.
  • Conduct descriptive analyses and assist the Study Investigators in development, writing and editing of presentations and publications of study findings, as well as preparing data for reports to the IRB, DSMB, and NIH.

Training and Supervision:

Directly supervises other GAP study staff and trains community partner (Lifespan) in research methods and ethical practices for human subjects research.

  • Directly supervise other GAP staff (CRC Assessor, CRC Interventionist, Student interns) in all tasks, including ethical human subjects protections, interviews methods and procedures, recruitment strategies, scientific ethics, and all day-to-day tasks.
  • Directly supervise life review interventionist (CRC Interventionist), including guidance on intervention delivery and fidelity.
  • Directly supervise CRC Assessor in conducting study assessments accurately and monitoring Assessor's clinical judgment and providing education and additional training as needed.
  • Coordinate orientation for new study staff, including research ethics and cultural competency.
  • Utilize professional judgment in implementing strategies to ensure fidelity to the volunteering intervention with the community partner, including providing training in research principles and ethics.
  • Coordinate and conduct study inter-rater reliability tasks for study assessments to ensure high quality work is being produced by all study staff.

*Coordination of Recruitment, Data Collection and Retention: *

Oversee and coordinate all study efforts in recruiting subjects, collecting assessment data, and retaining subjects in a longitudinal study for one year.

  • Organize and direct subject recruitment efforts for the trial, including interfacing with the physicians and staff of the Greater Rochester Practice Based Research Network (GR-PBRN). Working with busy physicians requires substantial interpersonal skill and judgment, so as to minimize burden on physicians and staff while meeting study objectives.
  • Supervise study staff in the development of study recruitment materials.
  • Oversee subject contact to enhance participation in follow-up interviews and provide appropriate support to subjects in distress.
  • Establish and maintain ongoing contact with study staff to assess patient safety; provide regular reports to the Principal Investigator, and data and safety monitoring board regarding patient safety issues.

*Data Management and Analysis: *

Oversee and supervise database creation and management; conduct analyses for the Pl.

  • Supervise other study staff in the development of the study REDCap database.
  • Oversee direct data entry procedures via iPads.
  • Complete regular subject chart reviews, ensuring fidelity of documentation procedures.

*Subject Assessment and Data Collection: *

Conduct eligibility assessments and follow-up interviews as needed.

  • Conduct screening and baseline assessments with potential subjects, including informed consent, determining study eligibility, conducting psychosocial interviews.
  • Utilize interpersonal skills, clinical knowledge and judgment to engage subjects, encourage personal disclosure of sensitive material, and keep subjects on track through follow-up assessments; use clinical judgment to provide appropriate support and clinical referral (following protocols) or other aspects of safety protocol.

The Lead CRC will subscribe to the department's goal of creating a culturally competent environment by treating research subjects and co-workers in a sensitive and caring manner. The CRC must maintain eligibility to participate in research involving human subjects by completing the Human Subjects Protection Program (HSPP) and NIH's Good Clinical Practice training. This position also requires participation in available cultural competency training

Qualifications:

  • Bachelor's degree plus 3 years relevant experience (5 years’ experience preferred) or equivalent combination of education and experience in study coordination.
  • Certification as a Certified Clinical Research Coordinator (CCRC) preferred.
  • Familiarity with Microsoft Access and REDCap preferred.

EOE Minorities/Females/Protected Veterans/Disabled

Job Title: Human Subject Res Coord II

Location: School of Medicine & Dentistry

Job ID: 201888

Regular/Temporary: Regular

Full/Part Time: Full-Time