Clinical Trial Amendment Manager

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.


Job Description

The Clinical Trial Amendment Manager is responsible for working together with Sponsors/CROs, Principal Investigators, study teams and ancillary services to provide a smooth and efficient study maintenance process. The Clinical Trial Amendment Manager is responsible for the evaluation and negotiation of amended clinical research study budgets, understanding the coverage analysis to determine where study costs should be charged, ensuring consistency in research pricing and payment terms and harmonization amongst coverage analyses, budgets, contracts, and consent forms.


K.S.A.'s

  • Bachelor’s Degree or equivalent professional experience.
  • Minimum of three to five years of work experience involving clinical trials, grant/research administration experience in a hospital, university or other research setting.
  • Experience with clinical trial budgets, clinical trial financial management, clinical trial agreements, and/or clinical research regulatory management strongly preferred.
  • Strong budget development/analysis and negotiation skills.
  • Knowledge of, and practical experience with, CPT codes, medical terminology, charge masters, and general research administration principles strongly preferred.
  • Strong verbal and written communication skills in order to address large, diverse audiences.
  • Ability to work independently and as a member of a team and follow through on assignments with minimal direction required. Self-driven project management skills.
  • Solution oriented with proven record of managing large scale research projects with diverse complexity required.
  • Ability to quickly reason with information to solve new, unfamiliar problems, independent of any prior knowledge.
  • Exceptional ability to distill complex clinical research protocols and related budgetary terms, so it is understandable to the lay audience.
  • Ability to handle high volume of work with changing priorities and constant interruptions and establish priorities and deadlines required.
  • Master’s degree and/or certification through Association of Clinical Research Professionals (ACRP), or Society of Clinical Research Associates (SOCRA), Certified Research Administrator (CRA)/Certified Financial Research Administrator (CFRA) preferred.
  • Personal computer skills; functional experience with integrated software systems and proficient in Microsoft Office applications.


Job Duties

  • Facilitate the management of clinical trial budget/contract amendments within Stanley Manne Children’s Research Institute.
  • Work with Department/Division faculty and staff to identify, analyze, negotiate, route, execute, and manage all clinical trial budget and contract amendments with industry, federal, and private sources.
  • Responsible for negotiating budget amendments with industry sponsors, ensuring document harmonization and compliance, facilitating timely execution of agreements, and accurate reconciliation of Study Tracker / Earnings Tracking System for comprehensive Sponsor reimbursement of clinical trial earnings.
  • Evaluate budget requirements and constraints to ensure the financial health of the organization.
  • Read, analyze, and interpret clinical trial study documents including Protocol, Coverage Analysis, Budget, Contract, Informed Consent, and Laboratory/Imaging Manual, etc.
  • Advise Department/Division faculty and staff on matters related to clinical trial budgets and contracts in a clear and professional manner.
  • Utilize extensive knowledge of the cost elements involved in studies, dealing with divisions/departments, OSP, ORIC/IRB, IDS Pharmacy, and other Ancillary support areas, as well as the hospital, to ensure profitable and efficient operation at all levels.
  • Establish professional relationships with pharmaceutical/device/biotech, CRO, and non-profit counterparts to facilitate amicable and timely negotiations.
  • Track data related to study start-up through the clinical research billing compliance processes.
  • Manage multiple concurrent projects, paying special attention to competing deadlines, complexity, and priority.
  • Monitor processing of Institutional Review Board (IRB) amendment submissions and approval of clinical trial protocols.
  • Work closely with the Clinical Trial Budget & Feasibility Specialist on intake of all new clinical research studies to initiate the process for financial and administrative viability review. Works closely with the Principal Investigator and study staff in coordinating activities and follow-up associated with determining the feasibility of amended clinical research studies.
  • Collaborate with Investigators, study teams, appropriate internal departments, and 3rd party vendors through the budget development process to ensure budgets meet internal and external deadlines as well as the needs of the Institution and external funding agencies.
  • Communicate with regulatory and contract staff to facilitate necessary language changes.
  • Represent OCCT on institutional committees and workgroups which focus on issues relating to research budgets, coverage analysis, and billing workflows.
  • Other job functions as assigned.


Benefit Statement

For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:


Medical, dental and vision insurance

Employer paid group term life and disability

Employer contribution toward Health Savings Account

Flexible Spending Accounts

Paid Time Off (PTO), Paid Holidays and Paid Parental Leave

403(b) with a 5% employer match


Various voluntary benefits:

  • Supplemental Life, AD&D and Disability
  • Critical Illness, Accident and Hospital Indemnity coverage
  • Tuition assistance
  • Student loan servicing and support
  • Adoption benefits
  • Backup Childcare and Eldercare
  • Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
  • Discount on services at Lurie Children’s facilities
  • Discount purchasing program


Lurie Children’s and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Ann & Robert H. Lurie Children's Hospital Of Chicago
Ann & Robert H. Lurie Children's Hospital Of Chicago

Current Openings: 0

Ann & Robert H. Lurie Children's Hospital of Chicago is the largest pediatric healthcare provider in the region with a 130 year legacy of excellence. We are proud to serve as the pediatric teaching and research partner of Northwestern University Feinberg School of Medicine, and are ranked nationally in all 10 pediatric specialties by U.S. News & World Report.
Are you an employee? 🌟
Explore Biotech Jobs

Find the one that suits your cosmic aspirations. Search open positions across the web, find opportunities uniquely matched to your skills, and read reviews on companies worldwide. 🚀💼🌎

Are you an employer? 🌟

Hire Top Talent in the Biotechnology Industry.

Post jobs, search for stellar candidates, and conduct the complete hiring process—all from your desktop or mobile phone. 🚀🔬👩‍🚀