Clinical Trial Start Up Administrator - Medicine

University of Massachusetts Medical School • Worcester, MA

89d

About The Position

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

Requirements

• Bachelor’s degree (or relevant experience) and 5+ years of related experience supporting faculty in clinical trial start up.
• Computer literate and proficient in the use of personal computers, spreadsheets, and word processing applications.
• Extensive Knowledge of Excel in developing sophisticated budgets.
• Experience with 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 and attention to detail.
• Works independently with minimal supervision; respects deadlines.
• Enjoys working in a fast-paced and challenging environment, and with all levels of UMass Med/UMMS staff.
• High Level of Confidentiality.

Nice To Haves

• Familiarity with activating clinical trials in OnCore.
• 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.

Responsibilities

• Acts 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.
• Acts 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.
• Act as an administrative hub to assist clinical faculty investigators and study coordinators in navigating the feasibility process.
• Coordinate the Complex Project Team, which brings together stakeholder groups across campus to allow clinical faculty investigators and new investigators to explain their research project(s) and coordinate hand-offs.
• Facilitates review of Financial Conflicts of Interest and Information Security during investigator initiated clinical trial protocol development.
• Assists in submission of studies to facilitate contracting (CDAs, CTAs, and amendments thereto), coverage analysis, and budget negotiations.
• Coordinates with other members of the Administrative Services Group in the Department of Medicine as necessary, especially in relation to grant proposals.
• Stays abreast of rules, regulations, and policy changes governing the conduct of clinical trials.
• Ensures 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.
• Cultivates relationships and communicates regularly with research & budget administration officials at internal and external stakeholders.
• Serves as a faculty liaison with sponsors, fostering ongoing relationships.
• Goal: To decrease study activation timelines.
• Goal: To decrease the administrative burden on clinical faculty investigators and study coordinators during the clinical trial activation process.
• Other duties and/or projects as assigned.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees