The Clinical Research Program Manager is primarily responsible for providing leadership and management of regulatory affairs and compliance as well as one or more of the programs within the section of Center for Cancer and Blood Disorders (CCBD) and assigned administrative operations. This Clinical Research Program Manager (CRPM) for will work across disciplines to develop, support, implement and evaluate effective regulatory affairs and research strategies for child health. They will provide expert regulatory guidance and direction of complex regulatory matters to all members of the research team at Children’s Hospital Colorado to ensure compliance with all applicable policies, procedures and regulations. They will also demonstrate the ability to provide strong and consistent direction in planning, organizing, implementing, and evaluating research operations including regulatory affairs. This position is responsible for duties that include, but are not limited to, the following: maintain the research program to meet all national standards and requirements of accrediting organizations including good clinical research practices, participate in annual program evaluation, support communications activities, serving as a program representative at meetings, and establish and maintain partnerships to advance the CCBD clinical research program as well as the Child Health Research Enterprise as a whole.
Develops individual goals within the program to enhance clinical research practice and professional growth by assuming a leadership role in clinical research education and the evaluation and communication of program’s clinical research goals and outcomes.
Directs and monitors direct reports to assure adherence to best research practices and assists with continuing education of program staff.
Participates in both tactical and strategic program development and planning.
Provides full supervisory authority over assigned staff; including recruitment, disciplinary action, performance evaluations and orientation and training.
Continuously strives to improve educational, research, and advocacy programs within the CCBD research program through collaboration with other clinical research leadership; sets and models high performance standards that empower staff to achieve desired outcomes as defined by CCBD research program leadership.
Contributes to and is accountable for adherence to national research standards and requirements of accrediting organizations in addition to all Federal and State regulations including collection and reporting of data to appropriate national registries, databases, and rating surveys.
Manages financial activities such as review and sign-off for effort certification and review and assessment of the expense reports of their direct reports.
Contributes to and is accountable for adherence to research practices developed and implemented across the CCBD research program as well as CHCO and CHRE.
Utilizes expert evidence-based practice to provide research expertise to direct reports. Provides follow up when desired outcomes are not achieved.
Develops presentations and other materials for use during program related events, trainings and meetings.
Education: Bachelor’s degree in a field related to human subjects research, biology or similar discipline.
Experience: Five yearsof clinical research experience with 3 years managing direct reports, and two years at an expert or leadership level.Expert knowledge in regulatory affairs and clinical research operations. Solid knowledge of computer use and software to include MS office and other software used for hospital operations.
Internal Number: 68500
About Children's Hospital Colorado
Here, it’s different. Come join us.
Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years.
Here, the nation’s brightest nurses, physicians, scientists, researchers, therapists and care providers are creating the future of child health. With an optimist’s outlook, a trailblazing spirit and a celebrated history, we’re making new strides every day.
We’ve been Magnet-designated three times by the American Nurses Credentialing Center and are consistently recognized among the nation’s top 10 pediatric hospitals by U.S. News & World Report.
As a national leader in pediatric care, we serve children and families from all over the nation. Our System of Care includes four pediatric hospitals, 12 specialty care centers, 400+ outreach clinics and 7,000 healthcare professionals representing the full spectrum of pediatric care specialties.
We need your expertise.
A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Here, it’s different. Do you have what it takes?