University of Rochester Medical Center · 1 month ago
Senior Human Sub Research Spec
Rochester, New York Metropolitan Area
Full-time
Onsite
Mid, Senior Level
$60K/yr - $85K/yr
5+ years expThe University of Rochester Medical Center is dedicated to improving community health through research. This role involves conducting clinical studies, managing subject recruitment, and ensuring regulatory compliance in urology-related research.
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Responsibilities
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
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
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
Qualification
Required
Bachelor's degree and 5 years of experience in human subject coordination required
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
Knowledge of computer databases including eRecord and ePARC, Word and Excel software programs
Preferred
SOCRA - Certification In Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred
Company
University of Rochester Medical Center
The University of Rochester Medical Center is one of the top academic medical centers in the country and the only one in our area.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
David H Klein
Special Advisor to the Medical Center CEO and Professor, Public Health Sciences
Michael F. Rotondo MD FACS
CEO University of Rochester Medical Faculty Group
Recent News
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