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Clinical Research Program Coordinator

Salary: $66,238 per year - estimated ?
Location: Church Street, NY
Company: Hospital for Special Surgery
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Overview

How you move is why we're here. ®Now more than ever.

Get back to what you need and love to do.

The possibilities are endless...

Now more than ever, our guiding principles are helping us in our search for exceptional talent - candidates who align with our unique workplace culture and who want to maximize

the abundant opportunities for growth and success.

If this describes you then let's talk!

HSS is consistently among the top-ranked hospitals for orthopedics and rheumatology by U.S. News & World Report. As a recipient of the Magnet Award for Nursing Excellence, HSS was the first hospital in New York City to receive the distinguished designation. Whether you are early in your career or an expert in your field, you will find HSS an innovative, supportive and inclusive environment.

Working with colleagues who love what they do and are deeply committed to our Mission, you too can be part of our transformation across the enterprise

Clinical Research Program Coordinator

Full-Time

Overview:

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 administrative 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 Finance Administrator for the CRA, the Program Coordinator is responsible for providing comprehensive support including pre/post award assistance for multiple research projects within the assigned Service Lines. The candidate will assist in standardizing and automating systems supporting Research Administration best practices including Lawson's Grants Management, Clinical Trials Management System (CTMS), and EPIC.

Duties and Responsibilities: Under the direction of the Finance Administrator, the Program Coordinator will provide support including 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
  • Assist assigned Service Line research staff in creating study specific budgets for new protocols
  • Assist the research team to effectively communicate non-standard care services for each protocol and assist with creation of billing grid templates
  • 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 the EPIC Administrator to create study records and billing calendars in EPIC and assist with creating study and billing calendars in CTMS
  • Assure that QCTs are identified and set up 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
  • 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
  • Assist the research team with the allocation of personnel costs during the quarterly offset process
  • Assist the Finance Administrator to process applicable personnel change forms
  • Other special projects as necessary including training and education to the assigned service lines regarding the internal startup process

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 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
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