Under the general direction of the Vice Provost for Clinical Research in the Center for Clinical and Translational Science or designee, the Director of Clinical Research Operations is responsible for the day-to-day activities required to facilitate clinical research implementation across UMMS, UMass Memorial Medical Center, and the UMass Center for Clinical & Translational Science. This individual will promote sponsor relationships, review and provide oversight for clinical study contracts and budgets, and be responsible for all operational issues that influence clinical research implementation and on-going study activities for adherence to federal, state and local regulations, standards and policies.
Oversight of contract and budget development to support clinical research, including the production of reports to evaluate research operations
Provide leadership for day-to-day operations and staff activities to support clinical research implementation and ongoing study conduct through the Center for Clinical & Translational Science and the UMass Memorial Medical Center
Provide guidance to clinical investigators and clinical research staff on individual study projects, focusing on feasibility, initiation issues and best practices
Provide leadership related to external industry relationships, including interacting with pharmaceutical and device companies when potential trial opportunities are presented
Oversee and review approval of all clinical research-related Confidentiality Agreements, Data Use Agreements and Clinical Trial Agreements and maintain signature authority for these documents
Collaborate with senior medical school and hospital leadership to facilitate the efficient conduct of clinical research, including the development of policies and procedures to support same
Collaborate with Vice Provost and Center for Clinical & Translational Science to set educational priorities; participate in education and training of clinical research staff across the institution
Manage staff, including hiring, performance appraisals, employee development, performance improvement, and termination
Perform other duties as required.
Bachelor's degree in a health-related field or related experience
7 years' experience in clinical research in either academic or industry setting
Expert knowledge and understanding of federal, state regulations and guidance related to clinical research
Ability to work independently on multiple projects and prioritize confidential issues
Superior communication, organizational and interpersonal skills, attention to detail and ability to facilitate cross-system decisions
Ability to problem-solve and work under pressure in a deadline-driven environment.
Master's degree in a related field
Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
Prior experience in an academic health center or hospital