University of Rochester Human Subject Res Coord I in Rochester, New York
Full Time 40 hours Grade 051 Medicine SMH Gastrointestinal
8 AM-4:30 PM
Assist Human Subject Research subject (HSRC) II and Senior HSRC with the coordination of activities associated with human subject research in the Gastroenterology and Hepatolgy Division. Under general direction, this individual will be responsible for the recruitment, enrollment and follow-up of research subjects for several industry sponsored research studies while meeting regulatory, University and sponsor requirements for the projects.
Assist with the coordination of the administrative details required to initiate and conduct human subject research, such as, preparing IRB applications for submission to RSRB & WIRB. Assist the HSRC II with study start-up documents such as Department of Medicine Scientific Review from, ORP A sign-off form and completion of regulatory documents such as the 1572, Financial Disclosure forms and other form required by sponsor or the University. Modifies model consent forms templates per local requirements. Assists HSRC II with ongoing IRB submissions & with study close-out activities.
Ensures all study team members understand and adhere to atl aspects of all approved protocols, procedures and standards for documentation and communication. Under general direction from the Principal Investigator, assists with the training of staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation and case report form (CRFs) creation and completion, and adverse event reporting. May create training logs or protocol checklists.
Using knowledge of Good Clinical Practice standards to assist with development and implementation of methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Under direction of the HSRC II, create source documents and case report forms. Reviews and documents the dispensing and returning of study materials (such as study drugs). Responsible for data entry and upkeep of various EDC systems and provides data clarifications as needed. Files study related information appropriately to help maintain accurate and up-to-date regulatory and study subject binders.
Performs human subject recruitment and screening activities to identify potential study subjects. Activities may include review of electronic medical records, submitting request to i2b2 and reviewing investigator referrals and clinic appointments. Conduct interviews and informal informed consent reviews with potential candidates over the telephone. Mail out consent forms. Reviews medical history with the HSRC II to verify inclusion criteria are met before enrollment. Maintains HIPPA and Human Subject Protection compliance.
Participates in and serves as liaison for scheduled Sponsor monitoring visits (i.e., pre-study inspection, initiation, ongoing and close out visits). Attend investigator meetings and other meetings required per sponsor. Attend and participate in regular internal meetings.
Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, by attending educational seminars and workshops. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, trends in therapeutic areas relevant to research studies; makes recommendations and implements changes as appropriate. Attends educational seminars
Direct Patient Contact
Explains the study in detail. Obtain informed consent if delegated by the study Pl. Obtain re-consent from subjects under revised approved informed consent documents after obtaining IRB approval.
Serves as the primary contact for research participants. Conducts visits per sponsor protocols to ensure research participant adherence with protocol requirements. Conducts interviews with participant to document study drug compliance, completion of diaries, changes to medications, adverse events or other changes in health and reports deviations and SAEs to senior study staff, Principal Investigator, Sponsor and/or any other required recipients or entities; and to ensure all data are collected and secured within approved parameters and procedures. Schedules study visits within study parameters. Coordinate with other departments to schedule patients for procedures or tests per protocol.
Obtain vital signs, ECGs, questionnaires, or other assessments required per protocol. Obtain and process blood, urine and stool samples per protocol. Package and ship biological samples and transmit other data to sponsor as necessary. Assists with ordering appropriate tests and laboratory supplies from vendors. Review laboratory or other testing results with the Principal Investigator in a timely manner. Obtain and maintain IA TA certification for shipping biologics.
Bachelor's degree and 1 year of experience in human subject research coordination; or equivalent combination of education and experience. Knowledge of word processing and data analysis software preferred.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord I
Location: Strong Memorial Hospital
Job ID: 206969
Full/Part Time: Full-Time