Clinical Research Coordinator 1, Urologic Surgery

Department
 

BSD SUR - Research Services

About the Department
 

Our renowned urologic surgeons oversee a broad range of surgical care programs, designed to thoroughly care for adults and children with complex urologic disease including urologic cancers in the bladder, kidney, prostate, and testicular regions. Further, our surgeons offer female urologic procedures including reconstruction, prolapse repair, salvage and urodynamics, among others. In addition to offering a wide range of surgical options, our experts are world leaders in robotic surgical techniques that enhance surgical and aesthetic outcomes for many urologic patients. The Section of Urology is also home to many busy laboratories, many of which are supported by the National Institutes of Health, the Department of Defense, and other major governmental and nongovernmental entities. With a special focus on cancer, our urologists are continually working toward discovering better ways to treat patients with urologic disease. This ongoing work and achievement would not be possible without the cohesive effort of the faculty and staff. We are always looking for individuals who are willing to work in our dynamic and collaborative environment toward the shared goal of improving the health of patients in our community and beyond.

Job Summary
 

The job provides technical support activities related to documents and reports on clinical research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. Plans and coordinates patient schedules for study procedures, return visits, and study schedules.

Responsibilities

• Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for one or two clinical trials. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.

• Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.

• Collects, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques.

• Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.

• Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.

• Organizes and actively participates in site visits from sponsors and other relevant study meetings.

• Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.

• Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.

• Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.

• Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Participates in study-related documentation,