Overview:

The Clinical Research Administration (CRA) has established a centralized service center to provide Principal Investigators and administrative leaders within Service Lines with efficient and standardized pre and post award management of clinical research projects.

As part of the centralized service center, the Clinical Research Program Manager is a Service Line liaison who interfaces across multiple HSS offices including Contracts Administration, Finance Research Accounting, Post Award Administration, Clinical Review Panel (CRP), Institutional Review Board (IRB), and Ancillary Departments to provide comprehensive support and facilitation of assigned clinical research projects and Service Lines. In collaboration with Principal Investigators and/or research teams, the Clinical Research Program Manager may also interact with numerous Pharmaceutical, Biotechnology, Device Manufacturer and Clinical Research Organizations.

Reporting to the Clinical Research Finance Administrator, the Clinical Research Program Manager is also responsible for trial facilitation and also the financial management of assigned clinical research projects and Service Lines.

Duties and Responsibilities:

Support includes assistance with clinical research study start up, protfolio management and study termination by:

• Reviewing and interpreting clinical research protocols for regulatory, budgeting, billing and compliance purposes
• Working with research team to effectively communicate non-standard of care services as defined by the protocol Principal Investigator and assist with creation of regulatory checklist
• Working with assigned Service Line research staff to build study specific budgets for new protocols and budget amendments, when applicable
• Accurately costing industry, collaborative investigator, foundation, and internally sponsored procedures with ancillary departments and hospital finance
• Ensuring the IRB approved informed consent, budget, payment terms, coverage analysis are consistent before finalizing documents and communicate with IRB and Contracts Administration as needed to correct inconsistencies

• Keeping a current understanding of project statuses within assigned Service Line and reporting statuses as requested
• Budget and payment terms review and approval and submission to Contracts Administration and study team prior to research agreement execution
• Collaborating with Contracts Administration to ensure timely execution of research agreements
• Internal budget and regulatory checklist review and submission to Clinical Research Finance Administrator
• Keeping a current understanding of FDA and CMS guidelines for clinical trial billing (Qualifying Clinical Trial (QCT) and Medicare Coverage Analysis (MCA)
• Ensuring QCTs are identified and set up as such in EPIC, Clinical Trial Management System (CTMS), E-CAP and that billing is performed in compliance with applicable regulations and payor requirements
• Reviewing New Account Request Forms and Internal Budgets and submitting to Clinical Research Finance Administrator for final approval
• Ensuring study team submit enrollment logs on a monthly basis
• Reviewing invoices sent by Research Accounting to study sponsors and payments received to

• Monitoring and account analysis of Lawson Grants Management, Lawson General Ledger and CTMS to ensure consistency of billing, accounts receivables, and accounts payables per agreement terms
• Monthly reporting of account monitoring and analysis
• Working with the Clinical Research Finance Administrator, Principal Investigators, department administrators, and research teams to complete personnel change forms and submit to Clinical Research Finance Administrator for review and approval for the allocation of personnel costs on a quarterly basis
• Prompting Research Accounting of final study close outs and reviewing final financial reconciliation at study closure to ensure all funds have been received per agreement terms
• 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 or research manager
• 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
• 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 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

• 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