University of Rochester Human Subject Res Coord I - 224406 in Rochester, New York
Human Subject Res Coord I
School of Medicine & Dentistry
Full Time 40 hours Grade 051 Medicine M&D-Infect Dis Unit
TBD; WKNDS AS NEEDED
Temporary position with anticipated end date of 3/31/21. 40 hours 10/1/20-12/31/20, 20 hours 1/1/21-3/31/21
Responsible for the implementation and coordination of several projects in the Infectious Diseases Division, including assisting the development and implementation of study recruitment plans, protocol adherence, patient database management for multiple clinical research studies, and patient interviewing and consenting. Work may include conducting study visits associated with human subject research.
SUPERVISION AND DIRECTION RECEIVED:
Under the direct supervision of Center for Community Health and Prevention, with significant oversight from the COVID-19 Clinical Trials Unit (Rochester Victory Alliance).
35% Directly support the recruitment and retention of participation in COVID-19 vaccine trials.
20% Perform screening for the study by phone. Perform interviewing and consenting. Assist in clinical setting with greeting patients, the enrollment process, flow. Provide ongoing support and frontline connection to individuals enrolled in vaccine trials research, including but not limited to assisting with transportation to the treatment facility, interpretation or translation services, and assistance with navigating healthcare concerns. Assist the total recruitment of 2,500 individuals to the research registry, with the goal of 1,000 eligible participants by October 15, 2020, reflecting the demographics of the Greater Rochester region.
15% Ensure that all aspects of all approved protocols, procedures and standards for documentation and communication are adhered to. Under general direction from the Principal Investigator, train other staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) completion.
45 % Build community relationships, trust, involvement and long-term collaboration for a COVID-19 vaccine.
20% Support the development, implementation and ongoing evaluation of a regional plan to increase participation in COVID-19 vaccine trials research by groups historically underrepresented in research. Work collaboratively as a member of the recruitment team to address questions, concerns and provide education about vaccine trials to community members. Plan and conduct education sessions for key organizations and individuals to provide information on vaccine trial research and encourage participation, virtually or in-person when possible.
15% Coordinate the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials (i.e., brochures, advertisements, newsletters, etc.) to immediate team members and relevant others.
10% Keep current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and make recommendations. Demonstrate accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keep current with industry standards, best practices, and trends in areas relevant to research studies; make recommendations and implements changes as appropriate.
15% Coordinate the Constituent Advisory Group for COVID-19 vaccine trials
Work closely with Center for Community Health and Prevention Director of Community Health Partnerships (DCPH) to develop and implement an Advisory Group for vaccine trials. The Advisory Group will meet virtually every other week (October through June 2021) and be comprised of representatives from the HIV Trials Network (HVTN) Advisory Board (4-6), COVID-19 vaccine trials researchers (2), and additional community representatives (2-4).
Administer compensation mechanism for Advisory Group participants.
Oversee communications and coordination for the group, including but not limited to meeting scheduling, reminders and meeting notes. Advise meeting agendas in collaboration with DCPH.
5% Other projects and job duties as assigned.
Bachelor’s degree and one year of experience in clinical research or equivalent combination of education and experience. Proficiency in computer software applications including Microsoft Office programs such as Excel, Outlook, and Word, Databases such as RedCap,
Ability to learn and master existing department applications and future software applications and programs.
Excellent communication, interpersonal and organizational skills; highly persistent and energetic professional style; self-motivation and drive to reach goals/objectives.
Strong attention to detail, ability to digest and understand the study, and the strong ability to use good judgment in assessing each individual’s comprehension.
Individual with strong community connections, and previous work and volunteer experience within the community, highly preferred.
NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled