Assoc Dir, Clinical Res Ops

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Associate Director of Clinical Research Operations is an experienced professional who provides leadership and oversight of the daily activities for the Clinical Trials Program for the Division of Pediatric Hematology, Oncology and Stem Cell Transplantation at the Columbia University Irving Medical Center. Along with other members of the leadership team, the Associate Director will assist in the development of standards and guidance to maintain compliant and efficient clinical trials operations. The Associate Director of Clinical Research Operations will also be an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). This position reports directly to the Director and Division Administrator of the Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, and will also have a reporting relationship to the Director of Clinical Research Operations within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC).

At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. We apply the same rigor in our commitment to fostering an inclusive, thriving community and caring for our employees and their loved ones. We offer immediate eligibility and invest in our employees' families through comprehensive Health and Welfare , Employee Assistance , Tuition Programs , and Retirement Benefits .

"Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process"

Responsibilities

Personnel Management :

• Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations.
• Serve as a role model and resource to other members of the office.
• Meets regularly with direct reports.
• Participates in Performance appraisals.
• Provides counseling and / or assists in design and implementation of improvement plans.

Leads the evaluation of new candidates / applicants.

• Evaluates current staffing and positions to assist in the continued growth of the clinical research efforts of the division.

Training for Clinical Research Managers Clinical Research Coordinators (CRC) and Regulatory Coordinators.

Administrative :

• Member of the CPDM leadership committee.
• Participate in cancer center wide and other committees as assigned.
• Develop and promote a structure that will increase efficiency and streamline processes.
• Create and implement policies and procedures to ensure operational standardization.
• Serve as a mentor to clinical research personnel providing guidance, and leadership, and creating a development program.
• Monitors, directs and supervises staff in a manner that facilitates an efficient level of operations.
• In collaboration with Senior Leadership determine appropriate workloads and protocol assignments.
• Assures the subject data collected is organized and submitted in a timely manner.
• Develops quality control mechanisms to ensure accurate data reporting, clinical trial billing, and patient recruitment are completed.
• Assists with CRF development, accuracy, and implementation for investigator-initiated trials.
• Ensures CRMs, CRCs and Regulatory Coordinators are adequately prepared for and successfully manage all monitoring and / or auditing visits.
• Effectively communicate (written & oral) across the organization. Communicate and escalate unresolved issues at the appropriate time to the appropriate level of management Identify and initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work.
• Support efforts to recruit and maintain adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements.
• Work cohesively with the Division Director, Division Administrator, Medical Director, Investigators, Research personnel and Division / CPDM staff to assure compliant conduct of research protocols.

Research / Protocol Management :

• Assist in the management of portfolio strategy and protocol development.

Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings.

• Organizes projects and collaborates with the multidisciplinary team and other health care personnel as needed to complete assigned tasks.
• Attends regularly scheduled conferences and meetings.
• Works with Division Administrator & Department of Pediatric Research in preparation of budgets for grant and contract applications related to clinical research.
• Works with Division Administrator & Department of Pediatric Research - in the management the pre-award, post-award and close-out process of all sponsored projects.
• Oversee compliance with all funding agencies to assure that all required information is maintained and reported on a regular basis while identifying, analyzing and correcting any discrepancies.
• Develop and implement standard operating procedures and policies for all clinical research functions designed to assure that clinical trials within the division are carried out in compliance with applicable institutional, federal, and state regulations. These include those promulgated by the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services, and the Joint Commission.
• Develop and maintain standardized forms, and study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, and provide appropriate staff updates, in-services, training, etc.
• Serves as the key liaison for FDA inspections, sponsors or other audits as assigned.
• Oversees multicenter trials program including all sub-site management, auditing / monitoring, specimen collection, budget negotiations invoicing / payments and research fund accounting.
• Oversees the Regulatory personnel whose responsibilities include IRB submission process for new and continuing trials, informed consent development, Financial Disclosures process on all protocols; regulatory binder maintenance, protocol modifications and internal and external audits of regulatory documents of protocols on a regular basis.
• Serve as a liaison with internal partners in research, including the Department of Pediatrics, HICCC CPDM, Columbia Clinical Trials Office (CTO), Sponsored Projects Administration (SPA), the Institutional Review Boards (IRBs), and the Irving Institute for Clinical and Translational Science.
• Performs related duties & responsibilities as assigned / requested.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience required; plus, five years of related experience.

Preferred Qualifications

• Master's degree preferred.
• CCRP / CCRC certification preferred but should be completed within 6 months of hire.
• RN or MPH degree preferred but not required.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.