Good afternoon colleagues!! I received a LinkedIn request from Stevel Ebeling at Huron asking if I knew anyone who would be interested in a job opportunity he has available. Unfortunately I don't know anyone, but I offered to pass the information along in case anyone here might be interested. The position is based in DC, and Steve's contact information is listed at the bottom. Huron Research Enterprise Services Clinical Research Pre-Award Manager Location: Washington, DC The Clinical Research Pre-Award Manager is an essential part of the Huron Research Office, effectively carrying out the mission of outsourced and dedicated clinical research administrative expertise across the country. At its core, the Pre-Award Supervisor oversees the work product of the Research Office teams specializing in Coverage Analysis, Budget Development, Contract Review, and Sponsor Negotiations. The Supervisor works closely with each represented Research Office team to manage work product and data for both to clients as well as internal Huron leadership. The Supervisor also interacts regularly with Huron leadership to obtain further directional support and mission guidance specific to each Research Office team, ensuring that appropriate messages regarding effectiveness, compliance and technical enhancements are provided to the team on a regular basis. Job Responsibilities of the Clinical Research Pre-Award Manager include: • Provides general operational expertise across all pre-award aspects of the Research Office; oversees execution of each phase of research functionality; • Supervises and manages all Research Office personnel with regard to development of expertise and adherence to internal policies, procedures, and guidelines; • Maintains a close working relationship with prospective and existing clients as well as other Research Office stakeholders, addressing concerns as they arise while also messaging successes in an effective manner; • Works with Huron leadership to pursue new client opportunities in Clinical Research Operational space; • Supports the development and rollout of outsourced Huron teams and technology; • Works closely with internal consulting and technology teams to develop new competencies, strategies, and technological enhancements; • Manages the hiring and onboarding of new team members, focusing attention on areas of significant client demand or marketplace pressure; • Participates in, develops, and/or oversees routine training, and continuing education exercises across all areas of Research Office functionality; • Manages the flow of data, metric development, and corresponding reports both to clients as well as internal Huron leadership; • Carries out data auditing as necessary, analyzes areas of inefficiency or non-compliance, and influences positive change throughout the office; • Effectively manages time to meet deadlines; • Ability to multi-task, supporting multiple internal initiatives at one time; • Excellent work ethic and communication skills when interacting with internal teams or Huron clients; • Other duties as assigned. Position Requirements; • Bachelor’s degree or equivalent professional experience. • Knowledge of a wide variety of research administrative lifecycle processes, including but not limited to: clinical research coverage analysis, budget development, contract review, sponsor negotiations, research revenue cycle functionality, clinical trial management system operations, and general billing compliance; o Specific working knowledge and direct hands-on experience in several pre-award areas ideal; • Evidence of successful and effective team management; • Detailed track-record of direct client-facing experience: influencing client decisions, establishing productive working relationships, and appropriately managing / navigating challenges; • Excellent time and task management skills including adhering to project work plans, tight deadlines, unscheduled client requests, internal project budgets, and general process completion timelines; • Exceptional verbal and written communication skills; • Strong analytical and problem solving skills; • Must be self-motivated; • Must be a team player; • Demonstrated resourcefulness; • Willingness to accept and integrate constructive feedback; • Maintain detailed and organized files; Preferred Qualifications Include: • Experience working in an administrative/ business office of a university, hospital, research institute or shared service model. • Knowledge of federal regulations related to clinical research, including NIH regulations covering NIH funded inventions; • Working knowledge and experience with clinical trial regulatory documents such as study protocols, informed consent documents and study budgets; • Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations. • Knowledge of common contractual negotiating points such as indemnification, intellectual property, patient safety, confidentiality, billing, and publication; • Knowledge and application of the Medicare rules and regulations related to clinical trial billing, specifically the Clinical Trial Policy and other guidance surrounding investigational devices; • General understanding of Grants Management pre and post award processes, ensuring compliance with the Office of Management and Budget Circulars, Uniform Grants Guidance, and other federal regulations; • Working knowledge of Clinical Trial Management System functionality, including calendar building, data entry, and reporting aspects; • Familiarity with accounts payable software as well as general financial management strategies, preferably related to hospital or clinical charge capture and processing; • Proficiency with: Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft Visio, and Adobe Acrobat. Huron offers a competitive compensation and benefits package including medical, dental, and vision coverage to employees and dependents; a 401(k) plan with a generous employer match; an employee stock purchase plan; a generous Paid Time Off policy; and paid parental leave and adoption assistance. Our Wellness Program supports employee total well-being by providing free annual health screenings and coaching, bank at work, and on-site workshops, as well as ongoing programs recognizing major events in the lives of our employees throughout the year. All benefits and programs are subject to applicable eligibility requirements. The Company is fully committed to providing equal employment opportunity in recruitment, employment, compensation, benefits, promotions, transfers, education and all other terms of employment. Huron will not discriminate on the basis of age, race, color, gender, marital status, sexual orientation, gender identity, national origin, religion, Vietnam era of veteran status, physical or mental disability, creed, citizen status or any other status protected by federal, state of local law. We endeavor to maintain a drug-free workplace. Contact: Steve Ebeling, Talent Acquisition 312-880-2651 | xxxxxx@huronconsultinggroup.com <br> ======================================================================<br> Instructions on how to use the RESADM-L Mailing List, including<br> subscription information and a web-searchable archive, are available<br> via our web site at http://www.healthresearch.org (click on the<br> "LISTSERV" link in the upper right corner)<br> <br> A link directly to helpful tips: http://tinyurl.com/resadm-l-help<br> ======================================================================<br>
