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The Clinical Trials Program Director (CPD) is responsible for administering and providing operational support, supervision, and management for research staff who conduct investigative activities within the Clinical Trials Office (CTO) and clinical departments as determined by the Medical Director of the CTO. The CPD will supervise and manage required tasks in collaboration with clinical coordinators, research assistants, regulatory specialists, research pharmacists as well as with other members of the research project team including investigators. The CPD along with the Medical Director will be responsible for representing clinical research operations at the research advisory council and for managing research operations activities as assigned with an entrepreneurial strategy that involves the ability to multi-task on a broad spectrum of activities with a global external focus on procurement of industry sponsored trials.
1) Oversee the daily operations of the Clinical Trial Office (CTO). Responsible for hiring, orientation and ongoing supervision of staff. Complete and deliver annual performance evaluations through Baystate Health's performance management system.
2) Collaborate with Sponsored Programs Administration, the Institutional Scientific Review Committee, Research Finance, research coordinators and investigators to evaluate the workflow, costs and feasibility associated with proposed Clinical Trials.
3) Responsible for managing clinical research activities both within the CTO and overseeing those within the clinical departments, including trial timelines, recruitment goals, budget resource requirements and data quality.
4) In collaboration with the Medical Director, develop clearly defined strategies to designate cross-functional interdisciplinary initiatives including process improvements.
5) Establish key performance metrics in alignment with Office of Research, CTO and departmental goals, as well as sponsor objectives. Develop monthly, quarterly and annual reports as needed.
6) Responsible for the development and implementation of CTO policies and standard operating procedures.
7) Develop and implement training programs to meet the training needs of research coordinators/assistants in research operations across Baystate Health to foster high level of performance and support career development
8) Collaborate with the Human Research Protection Program to develop and implement training programs to meet the training needs of research coordinators/assistants in research regulations and compliance across Baystate Health
9) Ensure that required quality control components of CTO meet compliance within clinical research areas throughout the organization as well as those of sponsors.
10) Cultivate and leverage relationships with faculty, departments, practices and leaders both within and external to BH to identify collaborative opportunities for BH Office of Research/CTO that meet the research and strategic goals of Baystate Health's mission and vision.
11) Maintain CTO service standards, with noteworthy attention to person/behavioral, staff teamwork.
Bachelor of Science (Required)
Driver License – Other
You Belong At Baystate
At Baystate Health we know that treating one another with dignity and equity is what elevates respect for our patients and staff. It makes us not just an organization, but also a community where you belong. It is how we advance the care and enhance the lives of all people.
DIVERSE TEAMS. DIVERSE PATIENTS. DIVERSE LOCATIONS.
For more information, please visit us online and apply to job req# R10495 at: baystatehealthjobs.com or interact with us socially at facebook.com/BaystateCareers or on Twitter @BaystateCareers.
Baystate Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, ancestry, age, genetic information, disability, or protected veteran status.
Baystate Health is a nationally ranked, award-winning, multi-institutional healthcare system located in the beautiful Connecticut River Valley of Western Massachusetts. Baystate Health was recently recognized as a Thompson Reuters Top 15 Health System for outstanding clinical performance and quality outcomes and Baystate Medical Center was recently recognized as the #5 overall “Major Teaching Hospital” in Thompson Reuters 100 Top Hospitals for their overall organizational performance in patient care, operational efficiency and financial stability. Baystate Medical Center is a Leapfrog, Top Hospital and a Magnet Hospital for Nursing Excellence. Our hospitals and practices are just steps from the ivy-covered buildings of prestigious colleges and universities, and we enjoy easy access to Boston, New York City, the snow covered slopes of Vermont, and the beaches of the Cape and Islands. Finding your niche is easy — it starts with Baystate Health.