Clin Rsearch Reg Spt Spc II

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The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

ESSENTIAL FUNCTIONS
Auditing Responsibilities:

• Establishes the schedule of monitoring visits to 30+ off‐site affiliates of the NCORP Research Base in accordance with National Cancer Institute Clinical Trials Monitoring Branch (CTMB) Guidelines; notifies sites; assembles audit teams; arranges details of the visit; prepares materials, reviews all regulatory documentation, consent forms and drug accountability records; compiles subject cases to be audited; prepares forms and checklists for audits.
• Leads remote and in person off‐site audits to ensure research activities are in accordance with the National Cancer Institute (NCI) Guidelines, Clinical Trial Monitoring Branch (CTMB) Guidelines, and Good Clinical Practice Guidelines. For example, verifies that regulatory documentation and informed consent form requirements conform to IRB regulations and guidelines; verifies that pharmacy operations and record‐keeping, using NCI drug accountability logs, document overall agent accountability and inventory control; and verifies source data for patient cases comply with protocol requirements.

Quality Assurance Responsibilities:

• Prepares documentation for the auditing/regulatory team such as SOPs, spreadsheets, process documents, training materials, summary documents.
• Acts as back up for Data Safety Coordinator and assists in preparing/reviewing study progress reports for the Data Safety Monitoring Committee.

Regulatory Responsibilities:

• Works with the Regulatory Specialists as a regulatory resource and back-up to submit new concepts, new protocols, protocol amendments, annual IRB renewals, study closures and reportable events to the NCI and/or IRB, as applicable.

Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 1 year of relevant experience required
• Master’s degree is preferred with major coursework in appropriate health, social or technical field
• 5 year of experience in clinical trials research and minimum 3 years of experience in monitoring/auditing/quality assurance/quality improvement. Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials; strongly preferred. 
• Or equivalent combination of education and experience

KNOWLEDGE, SKILLS AND ABILITIES

• Fully adheres to applicable safety and/or infection control standards required
• Understands and follows data integrity standards and processes required
• Ability to effectively manage a higher volume of protocols preferred
• Ability to effectively manage moderately complex research protocols/procedures preferred
• Possesses a high degree of self-motivation preferred
• Recognized ability to function independently preferred
• Proficient in managing multiple and competing priorities/demands preferred
• Detailed-oriented in record keeping and research documentation preferred
• Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred
• Strong interpersonal, communication, and organizational skills preferred
• Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred
• Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred
• Fluent in English, with excellent written and verbal communication skills and a high level of professionalism when interacting with faculty, leadership, and research personnel strongly preferred.
• Demonstrated leadership skills and knowledge of clinical research protocol planning, implementation, coordination, evaluation, and reporting strongly preferred.
• Proficiency in medical terminology, clinical research processes, and applicable regulatory guidelines and standards strongly preferred.

LICENSES AND CERTIFICATIONS

• Clinical research certification from an accredited organization, such as Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SOCRA) 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.