Director, Clinical Trials Activation & Pharmaceutical Relationship Development

Location
Monrovia, California
Salary
Competitive
Posted
March 27 2019
Ref
10001539
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

Clinical trials are a key research tool for advancing medical knowledge and patient care at City of Hope and the time it takes to activate a clinical trial is a key metric for comprehensive cancer centers. Monitoring the clinical trial activation across the disease and modality team portfolios enables allows COH to monitor and drive both operational and financial clinical research improvements as well as reinforce public perception of COH as a leading institution in providing access to cutting-edge clinical research for patients and industry alike. Further, the time to trial start-up impacts COH's ability to efficiently evaluate the potential for innovative and novel therapies, especially those that begin within COH basic laboratories, to benefit patients. Our goal is to create a systems approach to clinical trial activation, where we act, think, and perform as a system, rather than as siloed components of the activation timeline process. Research Operations seeks to scale pockets of best practices to the entire research enterprise as well as adopt successful practices from peer institutions. The new model for the clinical trials enterprise includes an organizational structure of disease and modality teams, central infrastructure, and governance oversight.

Under the direct supervision of the Senior Vice President of Research Operations, the Director, Clinical Trials Activation & Pharmaceutical Relationship Development (CTA/PRD), will partner with COH scientific and operational leadership to develop and implement best practices to optimally assist with the execution and activation of therapeutic clinical studies being conducted at City of Hope. S/he is at the heart of monitoring complex, highly-regulated protocols that have been endorsed by the Disease and Modality Teams, working in coordination with multiple parties inside and outside City of Hope to offer patients hope for more innovative and successful treatments than would otherwise be available.

The CTA/PRD will also lead institutional efforts to strategically align with targeted pharmaceutical partners in clinical research operations. Given that clinical trial activation time is a key metric for pharmaceutical study sponsors, the CTA/PRD will bring deep insight into both study-specific activation efforts as well as the overarching workflows and processes underlying this critical function. The CTA/PRD will also leverage their institutional knowledge and cross-domain expertise to support key partner research across all aspects of the clinical research life-cycle, from initial pipeline discussions and feasibility through study conduct and data collection, ensuring that preferred partners consistently receive best-in-class service.

The primary responsibilities for the CTA/PRD include organizing, directing, and overseeing the daily operations of the clinical trial activation process and tracking all operational aspects of research studies within each disease and modality team with each of the three stages: pre-submission, regulatory and activation. This leader will also facilitate efficient and effective communication and will work closely with the Medical Directors of Clinical Trials Office (CTO) and the Briskin Center for Clinical Research (BCCR), as well as the Senior Directors of Research Protections, Clinical Trials Office, Community Practices, the BCCR, Research Data Management and Analysis and Clinical Research Support Services to develop and ensure a successful and compliant operational process for sustained clinical research growth.

The CTA/PRD will also oversee and support all clinical research sponsor relationship development efforts and will serve as the primary point-of-contact for preferred partnership alliances. Further, the CTA/PRD will assist the research operations leadership team in developing and executing strategic and operational plans for clinical research at City of Hope. The Clinical Trials Administrator will exemplify the City of Hope mission, vision and values and acts in accordance with COH policies and procedures. The Clinical Trials Administrator assures that all COH clinical trials meet the highest standards for speed, safety, effectiveness, and quality in a manner that enhances the clinical and research reputation of the organization both nationally and internationally.



Key Responsibilities include:
  • Monitor and enhance progress to reducing the therapeutic trial activation timeline. Lead targeted weekly meetings and develop/execute escalation plans as required. Identifies bottlenecks in the protocol activation process to ensure that protocols are moved through the system as quickly as possible from disease team endorsement to activation
  • Conduct regular meetings with stakeholders and management to discuss timeline process and impact of improvements. Creating transparency for Disease Teams and PIs related to protocol study startups, placement in activation timeline through reports and metric dissemination. Develops, implements and leads internal communication strategies that support and promote protocol activation and other initiatives at COH
  • Streamlines the protocol activation process by serving as a liaison to coordinate effort between COH's various administrative and regulatory offices including the CTO, HRPP, RSS, IDSA, etc. to ensure efficient study start-up and all checks and balances are in place (e.g. DT endorsement, budget, contract and IRB approval,) prior to initiating a clinical trial
  • Acts as an internal consultant to further improve systems and processes related to protocol activation as defined by COH's strategic initiatives. Participates in the development of standard operating procedures (SOPs) and maintenance of administrative operating procedures manual
  • Maintains a portfolio of all endorsed protocols and tracks the activation process including notifying leadership of issues that require escalation. Assumes the responsibility for resolving and coordinating the resolution of system and/or process issues including developing efficient work flows
  • Works with disease teams and research leadership to provide status updates and manage specific tasks that are cross-functional in nature to ensure efficient protocol activation. Coordinates the collection and reporting of performance metrics including preparing annual and quarterly progress reports as directed. Ensures that all therapeutic study activations are accurately tracked in OnCore to support accurate data reporting.
  • Assists leadership with the development and implementation of metrics for evaluating success of protocol activation initiatives and other strategic priorities
  • Serves as the designated point-of-contact for City of Hope's preferred pharmaceutical partners, managing ongoing relationship development and alliance management meetings / updates. Tracks sponsors' study portfolios and proactively addresses potential challenges related to timely study activation, patient accrual and data entry / query resolution, assuring that City of Hope is able to meet sponsor study metric targets.
  • Manages all escalations related to preferred partner research, whether raised internally or externally, ensuring prompt and satisfactory resolution. Monitors trending and quickly identifies any ongoing or recurrent issues that require operational review and/or CAPA creation. Ensures transparent reporting of all escalations to Research Operations leadership.
  • Directly supports the Senior Vice President of Research Operations in ongoing pharmaceutical relationship development and proactive outreach to targeted sponsors to drive development of new partnerships that support City of Hope's strategic vision.
  • Directly responsible for the organization and conduct of all collaboration meetings between City of Hope and pharmaceutical sponsors related to clinical research.

Basic education, experience and skills required for consideration:
  • Must have BA/BS degree;
  • Must have five years progressively responsible experience related to Clinical Research.
  • Must have minimum of three years of experience related to the management and conduct of clinical research in an academic setting required.
  • Must have experience in coordinating and managing different aspects within the clinical trials arena.
  • Must have excellent skills in interpersonal communication and organization, as well as the ability to problem-solve and multi-task.
  • Must have working knowledge of policies and procedures that govern clinical research, including but not limited to FDA regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA), National Cancer Institute Cancer Center Support Grants (NCI CCSG) requirements and City of Hope Comprehensive Cancer Center programs and processes.
  • Must have good prioritizing skills and ability to handle direction and variety of work from several staff members. Able to easily switch from task to task as priorities change in a fast-paced office environment.
  • Must have knowledge and experience in managing clinical trials.
  • Must have knowledge of regulatory guidelines and requirements for the conduct of clinical trials and research subjects protection.
  • Must have knowledge and experience in the clinical research environment, especially in an academic health care setting.
  • Must have strong Excel/Database Skills.
  • Must have broad knowledge of medical terminology.
  • Must demonstrate confidentiality and meticulous attention to detail is very important.

Preferred education experience and skills:
  • Master's degree(s).


City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

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