Clinical Research Regulatory Support Specialist 2

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:

400119 Surgery-Cancer Control

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108

Compensation Range:

$52,300.00 - $73,300.00

Responsibilities:

The Clinical Research Regulatory Support Specialist II oversees the conduct of our affiliated NCORP sites throughout the nation, regularly reviewing their research activities to ensure activities adhere to Research Base SOPs, the approved clinical research protocol, CTMB guidelines and federal regulations.

The URCC NCORP Research Base is a large, complex, and dynamic operation involving many investigators, cross-functional teams, and laboratories. This program is funded by a $40M NIH grant and provides the infrastructure to conduct large multi-site cancer control and cancer care delivery clinical trials within our national network. The Research Base’s network is comprised of over 800+ community oncology practices and thousands of oncologists, advanced practice providers, pharmacists, administrators, research nurses, clinical research coordinators, data managers, regulatory specialists, and quality assurance staff nationwide. The Research Base portfolio includes prospective, cohort, and longitudinal Phase II – III randomized clinical trials.

As the Lead Auditor for the NCORP Research Base and working with the Manager, Clinical Research Quality & Education, this position is responsible for quality assurance and auditing activities.

The incumbent, using the required advanced degree of experience and working knowledge required of the role, informs
and authors SOPs, independently creates educational and training materials and spreadsheets tracking key program
metrics. This role educates and ensures compliance of all Research Base personnel and external scientific collaborators in
best quality assurance practices and federal regulations. Using the high degree of independence and autonomy required of this role, the incumbent must also be capable of covering for both the Manager, Clinical Research Quality & Education (their manager) and the Regulatory Specialists (their peers).

The URCC NCORP Research Base is part of the Department of Surgery, Division of Supportive Care in Cancer with our offices being located in the Saunders Research building. This role is required to be in-office, with work hours/availability during standard business hours, within approximately 8:00am – 5:00pm. Occasional work outside of standard business hours may be required.

Some travel may be required but is currently limited to approximately 1 to 2 meetings or conferences annually. Travel may periodically be required to perform on-site monitoring visits throughout our national network if the inspection is unable to be completed remotely.

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.

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