Clinical Trial Start Up Administrator - Medicine

Overview

Clinical Trial Start Up Administrator - Medicine at UMass Chan Medical School. Reporting to the Managing Director, Finance & Administration, the role provides fiscal evaluation to the Department of Medicine, including financial reporting, analysis, pre-award and post-award management, and clinical trial administration.

• Act as administrative hub for clinical faculty investigators within the Department of Medicine, to manage clinical trial start up activities for both investigator initiated and industry sponsored clinical trials.
• Work with clinical faculty investigators and study coordinators to vet the financial viability of proposed budgets for investigator-initiated trials. This may include vetting specific costs with the Office of Clinical Research, working under tight timelines for grant proposals, and escalating budget deficits to the Chair, Department of Medicine for review.
• Act as intermediary between clinical faculty investigators and pharmaceutical companies supporting investigator initiated studies when there is a budget deficit and additional funding is being requested.
• Assist clinical faculty investigators and study coordinators in navigating the feasibility process, including escalation to UMass Memorial when appropriate.
• Coordinate the Complex Project Team, bringing together stakeholder groups across campus to explain research projects and coordinate hand-offs.
• Facilitate review of Financial Conflicts of Interest and Information Security during investigator initiated clinical trial protocol development.
• Assist in submission of studies to facilitate contracting (CDAs, CTAs, and amendments thereto), coverage analysis, and budget negotiations.
• Coordinate with other members of the Administrative Services Group in the Department of Medicine, especially in relation to grant proposals. Provide pre and post award coverage for grants management as needed.
• Stay abreast of rules, regulations, and policy changes governing the conduct of clinical trials.
• Ensure clinical research award operational compliance with DOM and UMass Chan Medical School policies and external legal and administrative regulations.
• Disseminate information about changes in clinical research administration guidelines.
• Cultivate relationships and communicate regularly with research & budget administration officials at internal and external stakeholders.
• Serve as a faculty liaison with sponsors, fostering ongoing relationships.
• Goal:
  Decrease study activation timelines and reduce administrative burden on clinical faculty investigators and study coordinators during the activation process.
• Other duties and/or projects as assigned.

• Bachelor's degree (or relevant experience) and 5+ years of related experience supporting faculty in clinical trial start up.
• Computer literate with proficiency in personal computers, spreadsheets, and word processing applications.
• Extensive knowledge of Excel in developing sophisticated budgets. Understands the financial structure of clinical trials.
• Experience submitting regulatory documents to Institutional Review Boards and obtaining approval of clinical trial protocols.
• Experience with the feasibility process for clinical trials.
• Excellent communication and interpersonal skills.
• Excellent organizational and problem-solving skills with attention to detail.
• Ability to work independently with minimal supervision and meet deadlines.
• Enjoys working in a fast-paced environment with all levels of UMass Med/UMMS staff.
• High level of confidentiality.

• Familiarity with activating clinical trials in On Core
• Familiarity with Huron Research Suite
• Experience negotiating clinical trial budgets, including for investigator initiated studies
• Experience with pre and/or post award in grants management for institutions of higher education

Usual office environment / hybrid

The University of Massachusetts Chan Medical School welcomes all qualified applicants and complies with all state and federal anti-discrimination laws.