Manager, MN Research Operations - The Angeles Clinic & Research Institute

Cedars-Sinai•Los Angeles, CA

3d•$57 - $95•Onsite

About The Position

The Manager, MN Research Operations is responsible for planning, organizing, managing and controlling the daily operations of the research department. Assures all program development related to clinical trials within the research department follows the guidelines mandated by federal and local requirements including FDA research regulations. Builds and manages a team of highly skilled and efficient clinical research staff in an effort to assure compliance with regulatory agencies and with the ultimate goal of increasing enrollment on clinical trials. Is responsible for developing and implementing a program to train and mentor new clinical research staff, as well as providing ongoing education through focused in-services and recurrent meetings. Implements a comprehensive quality assurance (QA) and quality control (QC) program throughout the cancer institute. Serves as the resource for sponsor, cooperative group, and federal audits and is available to investigators and the research staff for routine and for-cause audit preparation and assistance and is responsible for developing and maintaining working instructions, document templates, and guidelines for the conduct of cancer clinical trials and other research. Completes assigned projects related to clinical research infrastructure development that will include, but not be limited to, cancer research radiology core services, research laboratory efficiencies, research pharmacy infrastructure, and will participate in the prioritization and scientific review of cancer protocols. Oversees the CTMS to assure utility, accuracy, and compliance.

Requirements

Planning, organizing, managing and controlling the daily operations of the research department.
Assuring all program development related to clinical trials within the research department follows the guidelines mandated by federal and local requirements including FDA research regulations.
Building and managing a team of highly skilled and efficient clinical research staff.
Developing and implementing a program to train and mentor new clinical research staff.
Providing ongoing education through focused in-services and recurrent meetings.
Implementing a comprehensive quality assurance (QA) and quality control (QC) program.
Serving as the resource for sponsor, cooperative group, and federal audits.
Developing and maintaining working instructions, document templates, and guidelines for the conduct of cancer clinical trials and other research.
Completing assigned projects related to clinical research infrastructure development.
Overseeing the CTMS to assure utility, accuracy, and compliance.
Developing staffing models for standardization of cancer clinical trials.
Working closely with research pharmacy and research lab to develop processes for smooth clinical operations related to research.
Working closely with PIs to constantly monitor processes related to clinical research and maximize research potential.
Providing consistency and continuity of quality-centered patient care for oncology patients.
Hiring, onboarding, managing schedules, personnel actions, performance reviews, and performance improvement plans.
Supervising the day-to-day work of employees, assigning work, ensuring tasks are completed and deadlines are met.
Planning, leading, and directing work of staff to ensure goals and objectives are completed within established budget and deadlines are met.

Responsibilities

Serves as the on-site manager for clinical research operations in the research department for which the overall organizational strategic plan and future direction is based.
Builds and oversees a team of highly skilled and efficient clinical research staff including clinical research coordinators, clinical research coordinators, clinical research associates, research nurses, and quality personnel.
Is responsible for developing and implementing a program to onboard, train, and mentor new clinical research staff; works closely with the research supervisors to ensure that all staff are trained, re-assessed if needed, and re-trained if needed.
Provides ongoing education through focused in-services and recurrent meetings for cancer institute staff including research nurses, study coordinators, clinical research associates, and regulatory staff.
Oversees and may serve as the primary contact and resource for sponsors and cooperative groups.
Participates in audits and coordinates the efforts of investigators and the research staff for routine and for-cause audit preparation and assistance; focus on clinical research issues during audits.
Develops and maintains working instructions, document templates, and guidelines for the conduct of cancer clinical trials and other research; Participates in cancer research policy revision and development.
Coordinates meetings with departmental management to provide feedback and helps Implement operational efficiency measures.
Completes assigned projects related to clinical research infrastructure development that will include but not be limited to cancer research radiology core services, research laboratory efficiencies, electronic medical record, clinical trial management system, and research pharmacy infrastructure.
Works closely to develop staffing models for standardization of cancer clinical trials.
Develops and implements a comprehensive quality assurance (QA) and quality control (QC) program.
Works closely with research pharmacy and research lab to develop processes for smooth clinical operations related to research.
Works closely with PIs to constantly monitor processes related to clinical research and maximize research potential.
Provides consistency and continuity of quality-centered patient care for oncology patients, specifically those in consideration for or actively participating in clinical research protocols.
Responsible for hiring, onboarding, managing schedules, personnel actions, performance reviews, and performance improvement plans.
Supervises the day-to-day work of employees, assigns work, ensures tasks are completed and deadlines are met.
Plans, leads, and directs work of staff to ensure goals and objectives are completed within established budget and deadlines are met.