Clinical Trial Start Up Administrator - Medicine

Overview

JOB SUMMARY

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.

MAJOR 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. 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.
• 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, including escalation to UMass Memorial when appropriate
• 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. Other responsibilities as assigned to provide pre and post award coverage for grants management.
• 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.

REQUIRED QUALIFICATIONS

• 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. Understands the financial structure of clinical trials.
• 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.

PREFERRED QUALIFICATIONS

• 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

ENVIRONMENTAL WORKING CONDITIONS

Usual office environment / hybrid