Lead Clin Research Reg Spt Spc

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 111

Compensation Range:

$63,815.00 - $95,723.00

Responsibilities:

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Provides mentorship and training to team members and provides coverage for assigned leadership as required. Responsible for performing the regulatory requirements of clinical research protocols and the day-to-day operations of the start-up or maintenance phase of all assigned protocols. Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure regulatory compliance. Mentors less experienced staff and participates in the broader Clinical Trial Office operations and objectives.

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 SOPs. Collects all regulatory documents required for submission to the Disease Working Group (DWG) and the Protocol Review and Monitoring Committee (PRMC), and collates them within Complion. Prepares/drafts Informed Consent Form (ICF) and insert institutional language ensuring language consistent with protocol. Enters and loads all required documents to OnCore and Complion. Coordinates and validates delegation log with the applicable DWG Clinical Research staff. Prepares and tracks submission to 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.
• Assumes leadership assignments. Serves as back-up to the Manager and assists or covers duties and responsibilities as assigned. Assists in training less experienced research personnel in research competencies, UR and department SOPs, and protocol specific training. Assumes the trainer role for proficiency in use of UR-specific research software needed for their clinical research studies. Takes a leadership role in special projects as assigned by CTO leadership. Resolves complicated issues relating to research processes and core support. Assists in the education and training of such information with applicable CTO staff.
• 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.
• Obtains and/or maintains clinical research certification. 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 required
• Or equivalent combination of education and experience
• 4 years 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
• Ability to mentor and provide training to junior members of the team 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
• Detail-oriented in record keeping and research documentation preferred
• Understands and follows data integrity standards and processes 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, and internet preferred

LICENSES AND CERTIFICATIONS

• CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year required or
• SOCRA - Certification In Clinical Research within 1 year required or
• CHRC - Certified in Healthcare Research Compliance within 1 year required

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