Assistant Director, Clinical Trials

Weill Cornell Medicine; New York (NY); On-site; USD 143,000 - 164,000; Full time

Job summary

Weill Cornell Medicine in New York's Meyer Cancer Center seeks an Assistant Director, Clinical Trials to oversee the administrative, operational, and clinical aspects of the Clinical Trials Operations Unit. You will drive strategic initiatives, optimize research operations, and lead high-performing teams to advance the clinical research mission.

The role partners with investigators, sponsors, and institutional stakeholders, ensuring regulatory and financial compliance and managing CTMS and

Qualifications

• Bachelor's Degree in related field
• Approximately 10 years of clinical research experience with supervisory/management experience
• Experience in data management, regulatory, budgeting and operations of clinical trial programs

Responsibilities

• Lead growth and development of clinical research, reporting on growth metrics and strategizing with disease leaders
• Provide clinical research training for new faculty and staff at the institutional level
• Assist with developing research-related grants, edits for submissions and reports
• Develop and implement SOPs and trainings
• Collaborate on budget development and AR reporting for trials
• Manage day-to-day operations and supervise clinical research staff
• Oversee ClinicalTrials.gov for assigned programs, update studies and endpoints
• Participate in instructional and QA committees for trial policies and workflow
• Support billing compliance and HRBAF submissions for protocols

Skills

Leadership

Project management

Stakeholder management

Communication

Supervision

Education

Bachelor's degree

Tools

CTMS

Microsoft Office

Job description

Title: Assistant Director, Clinical Trials

Location: Upper East Side

Org Unit: Solid Tumor & Others

Weekly Hours: 35.00

Exemption Status: Exempt

Salary Range: $143,200.00 - $164,300.00

As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices

Position Summary

Responsible for oversight of the administrative, operational, and clinical aspects of the Clinical Trials Operations Unit within the Meyer Cancer Center (MCC) CCTO. Serves as a key operational leader, driving strategic initiatives, optimizing clinical research operations, managing high-performing teams, ensuring regulatory and financial compliance, and fostering partnerships with investigators, sponsors, and institutional stakeholders to advance the clinical research mission.

Job Responsibilities

• Assists with bolstering the growth and development of clinical research. Creates and reports on business plans and metrics for growth and sustainability; strategizes with disease leaders to bring new studies and increase overall subject recruitment
• Provides clinical research training and education for new faculty and research staff at the institutional level. Develops training programs specific to new and current employees.
• Assists with and may act as the primary contact for the development of specific research-related grants. Develops and edits content for grant submission and reports.
• Assists with the development of standard operating procedures (SOPs) and trainings. Responsible for implementing SOPs and trainings.
• Collaborates with financial management leadership to streamline processes for budget development as it relates to clinical trials. Provides AR reports to monitor program productivity and ensure revenue is being collected timely and appropriately.
• Manages and advises on day-to-day operations of several multi-disciplinary clinical research programs. Recruits, hires and supervises clinical research staff.
• Manages oversight of ClinicalTrials.gov for assigned programs. As needed, adds new studies, edits existing studies, and updates the results for closed studies. Reviews accrual information, study endpoints, and research contacts for accuracy.
• Participates in and serves as a departmental representative for instructional committees regarding overall clinical research policies and work flow, including CTMA. Provides feedback on clinical trial operations, budgeting and staffing capabilities.
• Participates on audit committees as needed. Ensures preparedness for QA audits for investigator-initiated studies (internal and subsite), cooperative group studies and the investigational pharmacy.
• Responsible for billing compliance activities. Assists with the reconciliation of research cases. As needed, drafts and submits HRBAF's for protocols in assigned programs and disseminates research billing information for protocols to the study teams.

Education

• Bachelor's Degree in related field

Experience

Approximately 10 years of clinical research experience in an academic setting, including supervisory and management experience. Experience in data management, regulatory, budgeting and overall clinical trial program operations.

Knowledge, Skills And Abilities

• Proficient in Microsoft Office and experience with various clinical research software/clinical trials management systems (CTMS).
• Strong leadership and interpersonal skills.
• Ability to take initiative and simultaneously manage multiple projects with minimal supervision.
• Ability to manage high-pressure situations diplomatically and effectively set expectations.
• Strong facilitation, oral and written communication skills.

Working Conditions/Physical Demands

Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of "any person, any study." No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual's genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans' Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.