Assistant Director of Coordination Services and Education

Responsibilities

The mission of Coordination Services and Education (CSE) housed in the CTSI’s Office of Clinical Research (OCR) is to provide a sales and service solution to investigators and study teams requiring assistance with clinical research study start up, on-study coordinator support, regulatory maintenance, data entry services and clinical research training and education through three dedicated teams: Study Activation Team, Clinical Research Coordinator Team and the Education and Training Team. The Assistant Director of Coordination Services and Education is responsible for the development, implementation, coordination, and leadership (organizational, regulatory, and financial) of CSE SAT and CRC teams and clinical trial portfolios managed within CSE.

Essential to this role is personnel management, and resource allocation. As our Assistant Director of Coordination Services and Education, you will collaborate with principal investigators and the clinical research team to ensure awareness of all federal/state/local regulatory obligations related to the conduct and execution of clinical research. You will drive processes to ensure that CSE operations meet institutional operational research objectives as well as ethical obligations to research participants.  You will develop and manage business plans related to SAT and CRC services and oversee tracking and management of SAT and CRC sales and service activities related to the activities referenced herein and provide Health System leadership with metrics driven reports.

In addition, you will manage other research related projects, as assigned, and will solve potential challenges collaboratively and with professionalism and determination. You will elicit feedback and performance review from the Principal Investigator(s) and study teams to which the CSE SAT and CRC team members are assigned.

Job Qualifications

Qualifications

• Bachelor’s Degree in science, public health or related field strongly preferred
• 3-5 years of progressive experience in clinical research including research involving human subjects.   
• Demonstrated leadership skills including 2 years of progressive management experience.  
• ACRP, CCRP or similar clinical research related certification.
• Demonstrated working knowledge of FDA Good Clinical Practice and Good Laboratory Practice.
• Experience and familiarity performing study activation including IRB submission, other committees and ancillary services (coverage analysis, lab services, radiology services, pharmacy services, etc).
• Strong analytical skills sufficient to work and problem solve with minimal supervision.
• Ability to work flexible hours to accommodate deadlines.
• Strong interpersonal communication skills (both verbal & written) to effectively and diplomatically collaborate, ability to establish and maintain cooperative working relationship with staff, physicians, administrators and patients
• Strong computer skills and experience working with Microsoft Office applications, : word processing, use and development of spreadsheets, e-mail and data entry (MAC, PC, MS WORD, MS EXCEL, MS OUTLOOK).
• Demonstrated ability to navigate research platforms such as OnCore (CRMS), CareConnect (EHR), REDCap (EDC), etc.
• Ability to handle confidential material with discretion in accordance with Federal, State, and local laws and regulations, and consistent with Institutional policies.