Clinical Research Regulatory Specialist II

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:

Time as Reported / Per Diem

Scheduled Weekly Hours:

As Scheduled

Department:

400301 Emergency Research Admin

Work Shift:

UR - Day (United States of America)

Range:

UR URG 108 H

Compensation Range:

$24.91 - $34.87

Responsibilities:

Responsible for the coordination and oversight of regulatory requirements of clinical research protocols. Develops increased learned skills, flexibility in performing duties, and assumes responsibility for a portfolio of clinical research protocols under the direction of the Principal Investigator (PI) and senior leaders.

ESSENTIAL FUNCTIONS

• Prepares all regulatory documentation, document filing, tracking, and maintenance. Documents new study in tracking system. Maintains all logs, including OnCore, according to University of Rochester (UR) and department Standard Operating Procedures (SOPs). Collects all regulatory documents required to submit to the DWG and PRMC and collates essential regulatory documents within Complion. Prepares/drafts ICF and insert institutional language, ensuring language is consistent with protocol. Enters and loads all required documents to OnCore and Complion. Coordinates and validates the delegation log with the applicable DWG clinical research staff. Prepares and tracks submission to Institutional Review Board (IRB) (CIRB, RSRB, Commercial IRB), FDA, ClinicalTrials.gov, etc. Maintains regulatory records and necessary correspondence records. Submits IRB approval letters and approved consent forms to sponsors as required to ensure studies remain active. Prepares all protocol annual reviews, addenda, revisions, memos, safety reports, and consent form revisions for submission to the regulatory committees. Assists with coordinating center functions as they relate to on-site and other site(s) participation in clinical trials and affiliate participation. Prepares, submits, tracks, and responds to all regulatory (FDA and IRB) requirements, including safety and ongoing reporting for other participating site(s). Prepares and submits progress reports and renewals to the IRB and sponsors.
• Acts as a liaison with study team, sponsors, and all stakeholders. Liaises with sponsor regarding activation requirements and timelines. Liaises with other required stakeholders and committees, such as HURC, IBC, Cell lab/BMT Nurse Manager, Faculty, DWG, etc. Coordinates official internal activation. Informs study coordinators and physicians when re-consents are required. Liaises with Sponsor regarding maintenance of protocols.
• Assists Clinical Research Coordinators and investigators with study document management and tracking.
• Complies with Good Clinical Practice and the Code of Federal Regulations. Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same. Participates in protocol-related training as required.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 1 year of relevant experience required
• 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

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.