Senior Human Subject Research Specialist

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 Location (Full Address):

601 Elmwood Ave, Rochester, New York, United States of America, 14642

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400151 Urology M&D

Work Shift:

UR - Day (United States of America)

Range:

UR URG 110

Compensation Range:

$61,000.00 - $85,400.00

Responsibilities:

GENERAL PURPOSE
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.

Position requires the ability to work independently, strong interpersonal skills in communicating with adult subjects and their families, their health care providers, and hospital staff at Strong Hospital, Highland hospital and Urology Outpatient clinics. A willingness to develop the logistics of subject enrollment, persistence and flexibility in assuring on-going subject cooperation and good data collection skills. On occasion, this position may require travel to private medical offices and facilities in the Rochester area to enroll potential subjects and obtaining required samples.

ESSENTIAL FUNCTIONS

Clinical Study Visits and Clinical Assessments:

• 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.

Human Subject Recruitment:

• 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.

Research Team Collaboration:

• 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.

Quality Assurance:

• 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.

Other duties:

• 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.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 5 years of experience in human subject coordination required
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• 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

LICENSES AND CERTIFICATIONS

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

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.