Program Manager - Clinical Research

Overview

Program Manager

The Clinical Research Administration (CRA) has established a centralized service center to provide Investigators and Administrative leaders within Service Lines and Departments with efficient and standardized pre and post award management of clinical research projects by interfacing across multiple HSS offices including; Finance and Research Accounting, Quality Assurance and Compliance, Contracts Administration and Legal Affairs, Post Award Administration and Sponsored Research.

This candidate will provide management support for clinical research projects involving multiple PI's within multiple services/departments, regardless of funding sources (Federal, State, industry contracts, gifts/donations, sub awards, service agreements, and Foundation). In collaboration with the PI and/or research team, this candidate may also interact with numerous Pharmaceutical, Biotechnology, Device Manufacturer and Clinical Research Organizations.

Reporting into the Executive Director for Clinical Research, the Program Manager is responsible for providing comprehensive support including financial management for multiple research programs with Service Lines assigned to that Manager. The candidate will standardize and automate systems supporting Research Administration best practices including Lawson s Grants Management and the implementation of a CTMS system.

Duties and Responsibilities: Support includes assistance with Clinical Research study start up, portfolio management and study termination by:

• Reviewing and interpret clinical trial protocols/studies for regulatory and budgeting/billing compliance purposes
• Working with assigned Service Line research staff to create study specific budgets for new protocols
• Work with research team to effectively communicate non-standard care services for each protocol and assisting with creation of billing grid templates
• Accurately cost industry, in-house, and government sponsored trials with ancillary departments and hospital finance
• Collaborate with the Contracts Administrator to vet and finalize relevant CDAs and CTAs
• Keep a current understanding of FDA and CMS guidelines for clinical trial billing (Qualifying Clinical Trial (QCT) and Medicare Coverage Analysis (MCA)
• Work closely with Sponsored Research on Federal, State and/or Foundation sponsored clinical research grants
• Assure IRB approval and ICF is consistent with budget, coverage analysis and agreement before finalizing documents and communicate with IRB Administration
• Work with Clinical Research Administrator to create study records and billing calendars in EPIC and assist with creating study and billing calendars in CTMS
• Assurance that QCTs are identified and set up as such in Epic, E-CAP and Wellspring and that billing is performed in compliance with applicable regulations and payor requirements
• Assist with the internal cost center/account set up and monitoring of the account
• Review and develop applicable financial reporting metrics
• Monitor GM/CTMS of existing protocols with payment schedules, dollars received, dollars outstanding and amendments
• Review invoices as required by various study sponsors and in collaboration with Research Accounting manage collection of all outstanding receivables including milestone management
• Work with and assist Investigators, administrators, and research teams with the allocation of personnel costs during the quarterly offset process and process applicable personnel change forms
  

Other special projects as necessary including presentations to leadership, chairing and/or co-chairing relevant meetings, participate in hospital and research committees; produce various metrics report to improve operations, attend service line retreats, etc.

Minimum Qualifications

• Bachelor's degree in related area; Master s degree preferred.
• Proven ability to provide clinical expertise in all phases of clinical research trials.
• Two + years experience in clinical research as a coordinator
• Thorough understanding of research guidelines of Federal and non-Federal sponsors supporting research and educational activities, preferably in an academic environment.
• Thorough knowledge of applicable regulatory and compliance requirements related to use of human subjects in research, financial conflict of interest, IRB, etc.
• Ability to maintain independent judgment; strong organization and communication skills; and a customer service focus across broad and diverse subject areas.
• Maintains current knowledge of compliance regulations in all areas of research including QCT/MCAs.
• Ability to independently interpret, analyze, and implement appropriate policies in a given situation.
• Skill in prioritizing a high volume workload to ensure priorities and other deadlines are met. Demonstrated ability to work in pressure situations to meet deadlines and accommodate interruptions.
• Proven ability to assess and contribute to development of automated systems to facilitate award administration. Demonstrated skill in setting up and maintaining accurate filing systems.
• Experience applying programmatic knowledge to coordinate financial aspects of award administration.
• Demonstrated ability to maintain a professional attitude during interaction and collaboration with a wide range of personalities.
  

General Skills

• Proficient in Microsoft including, Excel and PowerPoint
• Excellent communication skills, written, oral presentation and interpersonal skills
• Excellent analytical and problem solving skills Independent thinking and planning ability
• Excellent written and verbal communication skills a must; and
• Good teamwork skills, as well as the ability to work independently.