Senior Human Sub Research Spec Job at University of Rochester (Rochester)

Job Description

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Responsibility

Participate in ongoing research studies in the Urology Clinical Trials Office relating to Oncology and General Urology. phase 1-3 industry and Investigator initiated studies, in therapeutic agents in adult populations.
Conducts unstructured interviews with subjects and families as required by protocol
perform clinical research related procedures (blood draws and sponsor specific delegated responsibilities)
measures, records, and reports indicators of patient health status
perform more specialized tasks such as Bladder Scans, pad weight tests, ECGs and Uroflowmetry
evaluates subjects for local or systemic reactions to determine adverse events to study medication.
Discuss with subjects’ potential adverse events and SAEs and participating in grade of events.
Participate in the reporting of subject serious adverse events (SAE) and filing of these in a timely manner to sponsors and IRBs.
Identification of subject pool, eligibility screening in clinic settings and/or telephone screens
medical history review
obtain informed consent and proceed with enrollment procedures
answers patient questions to ensure he/she understands the clinical study and their involvement.
Participate in performing all protocol required study procedures on subjects which include but are not limited to venipuncture, urine collection, Bladder Scans, Uroflowmetry, pad weight tests and ECGs.
Review and interpret study guidelines for next steps necessary for the processing and/or shipment of samples.
Track and prepare requests for payments to subjects
Ensures assigned studies are conducted accurately, conducts subject visits per protocol which may include standard-of-care visits, performs clinical research procedures (i.e., blood draw, urine sample collection), prepares, stores, and ships biological specimens, requests tissue from Pathology, verifies laboratory data, distributes study medication per protocol, documents adverse events accurately, consults with study investigators, regularly interacts with clinic, off-site, and laboratory staff as it pertains to subject visit requirements, follows subject visits.
Attend and participate in study team meetings, monthly research group meetings, and participate in unique sponsor-required training prior to study start
establish and maintain relationships with sponsor representatives for the purpose of regulatory compliance and quality assurance/control.
Organizes, develops, implements, evaluates, and manages all study documentation and multi-use electronic forms using Excel or Word.
Completes source documentation and CRF’s, enters data into various database websites, ensures accurate and complete information within specific timeframe, monitors and tracks subject visits via multiple spreadsheets.
Quality Assurance: Oversees Quality Assurance and Control to optimize ID site study performance.
Makes recommendations and implements changes to improve site study performance.
This includes but is not limited to source document verification and ensuring its accuracy and compatibility with case report form information. QA of charts to ensure subjects meet all of the eligibility requirements for study participation relating to GU Cancer, Kidney stones, infertility and other Urology related diseases and disorders
ensure procedures are performed per protocol and confirm that no deviations from protocol have occurred.
Ensures that all source document information is completed accurately and includes all information required by the study sponsor. Manages and oversees assigned studies, fully participates in the planning, development and implementation of study design, protocols, consent forms, study logistics, study budgets, quality assurance and other programs.
Reconciles invoices, initiates subject payments in compliance with protocol.
Conducts quality assurance activities.
Acts as liaison with study monitors, provides data clarifications, communicates with sponsor to clarify data queries, participates in sponsor monitoring visits.
Ensures regulatory applications are complete and associated documents are developed and submitted to RSRB in a timely fashion.
Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data.
Documents and maintains all study forms electronically or in binders.
Communicates with faculty and staff in the Urology Department, Wilmot Cancer Institute, RSRB, and various departments within the University relating to management and resolution of study issues.
QA of charts to ensure subjects meet all of the eligibility requirements for study participation relating to GU Cancer, Kidney stones, infertility and other Urology related diseases and disorders
ensure procedures are performed per protocol and confirm that no deviations from protocol have occurred. Ensures that all source document information is completed accurately and includes all information required by the study sponsor.
May supervise others and participate in onboarding new staff members.
Trains staff regarding activities associated with conducting human subject research guidelines and sponsor requirements, attends pertinent research seminars and meetings, inventories study supplies, performs POCT testing, performs Monthly QC checks on testing products as applicable, sign-off and training of other staff members for laboratory procedures.
Must have own transportation and be willing to travel to off-site offices depending on study requirements and supervise junior research staff at offsite locations under guidance of the Clinical Trials Manager.
Inventories study supplies, restocks exam rooms and organizes supplies and charts for each individual study protocol
assist with data entry, filing, mailings, source document development and compiling study summary data as needed.
Keeps current with regulations for conducting clinical studies according to good clinical practices, federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and makes recommendations and implement changes as necessary.
Create and implement SOPs and guidelines for Clinical Trials office with manager review and sign-off.
Liaison for Insurance approvals related to study participation and other duties as assigned by manager.

Requirements

Bachelor's degree and 5 years of experience in human subject coordination required
Or equivalent combination of education and experience
Phlebotomy skills for adult and pediatric patients and good computer skills Required
Independent and organized professional with superior interpersonal skills, sound judgment and good oral and written communication skill
Strong attention to detail and must be able to problem-solve effectively. Required
Knowledge of computer databases including eRecord and ePARC, Word and Excel software programs. Required

Nice to have

SOCRA - Certification In Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred

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