University of Rochester Human Subject Res Coord II in Rochester, New York
Full Time 40 hours Grade 053 Urology M&D;
8 AM-5 PM; OCC HOL
To serve as study coordinator for clinical trial activities in the Department of Urology. This position will report to the Senior Health Project Coordinator in conducting various investigator-initiated and sponsored studies through the Urology Department and in collaboration with the Wilmot Cancer Institute. Study population includes, but not limited to, bladder and prostate cancers.
Under general direction and with some latitude for independent judgment for the direction and results of the research:
Evaluates data to identify potential subjects via eRecord and clinic schedules, develops recruitment strategies and distributes recruitment materials (i.e., brochures, advertisements, newsletters, etc.), eligibility screening in clinic setting or via telephone, medical history review, confers with physicians, accurately conveys study information and answers subject questions, obtains informed consent.
Clinical Study Visits
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.
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.
Study Management/Regulatory/Quality Assurance
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. 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, must have own transportation and be willing to travel to off-site offices depending on study requirements. 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 implements changes as necessary. Other duties as assigned by manager.
Bachelor’s degree and 3 years of experience in human subject research coordinator; or an equivalent combination of education and experience. Strong communication and organizational skills required, attention to detail, and must be able to problem-solve effectively. Knowledge of computer databases including eRecord and ePARC, Word and Excel software programs. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. Phlebotomy experience a plus.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Human Subject Res Coord II
Location: School of Medicine & Dentistry
Job ID: 205972
Full/Part Time: Full-Time