Program Manager - ( 3274152 )

　　Description

　　About Spaulding Rehabilitation Hospital and the Spaulding Neurorehabilitation

　　Laboratory:

　　Spaulding Rehabilitation Hospital (SRH) is the flagship inpatient rehabilitation hospital for the Mass General Brigham Health System (MGB) and the primary teaching hospital of the Physical Medicine and Rehabilitation program at Harvard Medical School (HMS). MGB is among the largest academic health systems in the nation and is the only health system with three institutions ranked in the Top-20 Best Hospitals by U.S. News and World Report (Massachusetts General Hospital [MGH], Brigham and Women’s Hospital [BWH] and SRH). The mission of the Spaulding Neurorehabilitation Laboratory (SNL), directed by Dr. Joseph T. Giacino, Professor of Physical Medicine and Rehabilitation at Harvard Medical School, is to develop more precise diagnostic and prognostic assessment methods, and more effective treatment interventions, to maximize recovery and improve quality of life for persons with acquired brain injury. Areas of focus include the development of high-precision instruments and approaches to outcome assessment, neuromodulatory treatment interventions and knowledge translation. Lab members have a long history of leadership in drug and device trials aimed at fostering recovery after severe brain injury. Dr. Giacino led the team that identified the only medication that has been demonstrated to accelerate the pace of recovery following

　　severe TBI (i.e., amantadine hydrochloride).The SNL serves as the base of operations for the Spaulding-Harvard Traumatic Brain Injury Model System (SH-TBIMS), one of 16 centers in the U.S. funded by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) to conduct longitudinal follow-up of persons with moderate to severe TBI. The TBI Model Systems Program is the largest and longest-running longitudinal study

　　of TBI in the world with over 16,000 persons enrolled over the last 30 years. The SNL also co-leads the Outcomes Core for the nation’s largest prospective study of TBI, “Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACKTBI)” (https://tracktbi.ucsf.edu), an 18-site research network supported by the Department of Defense and the National Institutes of Health (NIH). The SNL also has a long tradition of involvement in national advocacy efforts intended to promote equitable delivery of health services to vulnerable populations https://www.neurorehablab.org/.

　　Position Summary

　　SRH is recruiting an experienced and highly motivated individual with strong research management skills to serve as Clinical Research Laboratory Manager for the Spaulding Neurorehabilitation Laboratory (SNL). The Laboratory Manager is primarily responsible for operational management of a large and diverse portfolio of research activities, including federal, industry and foundation-funded multicenter clinical trials and observational studies, communicating with institutional, academic, government, industry, military, and consumer advocacy partners and maintaining fiscal and

　　regulatory accountability. The Lab Manager works with and under the direction of the Laboratory Director.

　　Key Responsibilities

　　General Administrative

　　Ensures fluent day-to-day implementation of all laboratory operations

　　Demonstrates knowledge of, and compliance with, departmental, institutional, and federal rules and regulations pertinent to research activities.

　　Coordinates development and implementation of manuals of operating procedures and training certifications

　　Tracks and disseminates RFA/RFP announcements.

　　Oversees preparation and response to audit findings and recommendations.

　　Assists with interviewing, hiring, and on-boarding of study staff.

　　Coordinates and develops agendas for weekly laboratory meetings.

　　Financial

　　Maintains account ledgers.

　　Collaborates closely with departmental administrative personnel, and preaward and post-award personnel in grants and contracts office.

　　Reviews, tracks, and assures compliance with all contract/subcontract terms

　　and conditions.

　　Protocol Preparation, Implementation, & Review

　　Initiates and participates in development of new grant proposals.

　　Coordinates preparation of documents required for new submissions (e.g.,

　　biosketches, facilities and resources, letters of support, FDA Forms 1572,

　　CVs).

　　Prepares budgets/justifications for all new submissions.

　　Prepares IRB applications and monitors continuing review timelines.

　　Coordinates preparation of informed consent documents, case report forms

　　(CRFs), regulatory binders, enrollment logs, and drug/device accountability

　　logs.

　　Post-Award Activities

　　Develops a full understanding of all aspects of study protocols, and assists PI in communication responsibilities and requirements to study staff

　　Establishes and organizes study files, including regulatory binders, study specific source documentation, and other materials

　　Reviews, tracks, and assures compliance with all contract/subcontract terms and conditions, including IRB approvals, FWA assurances, conflict of interest disclosure, health, and safety protections for participants

　　Works closely with Grants and Contracts office to ensure accuracy and timely filing and receipt of study-related documents

　　Conduct of Research

　　Contributes to scientific activities/research studies in accord with academic training and professional background

　　Maintains effective and ongoing communication with sponsors, research participants, and PI

　　Assists with development, implementation and evaluation of recruitment strategies and enrollment targets.

　　Assists with adverse event reporting and data quality assurance.

　　Communicates with IRB and DSMB personnel

　　Meets regularly with research coordinators, research assistants, and students regarding daily operations

　　Assists the Principal Investigator in submission of accurate and timely closeout documents in accordance with sponsor requirements

　　Supervisory/Managerial Responsibilities

　　Oversee and manage growth of the SNL, including hiring and management of future staff (approximately 10.0 FTE) as well as research fellows, externs and students.

　　Fiscal Responsibilities:

　　Develop, oversee and manage the SNL’s budget.

　　Qualifications

　　Education/Degree

　　Required

　　Bachelor’s degree or higher from an accredited college or university (public health, neuroscience, medical sciences, psychology)

　　Master’s degree preferred

　　Experience

　　Required

　　Minimum of 5 years of experience in laboratory or research management

　　Understanding of hospital operations

　　Financial management

　　Preferred

　　Formal training or experience in neurorehabilitation researchSkills (Specific learned activity gained through training)

　　Required

　　Demonstrated strategic thinking, planning abilities and the ability to lead through both influence and direct authority.

　　Excellent communication, presentation, and facilitation skills with the ability to communicate effectively and to lead a broad range of stakeholders.

　　Strong analytical and critical thinking skills necessary to evaluate strategic initiatives and recommend changes, prior to implementing the processes.

　　Interpersonal communication skills to influence, negotiate, and resolve problems effectively and to make strategic and tactical decisions with senior

　　and clinical leaders.

　　Change management skills and knowledge, including competence in changing a vision into action by executing on strategy, partnerships, goals, andmeasurements.

　　Commitment to creating and championing Diversity, Equity, and InclusionPrimary Location : MA-Charlestown-SRH Spaulding Rehabilitation Hospital Boston

　　Work Locations :

　　SRH Spaulding Rehabilitation Hospital Boston

　　300 1st Avenue

　　Charlestown 02129

　　Job : Research-Management

　　Organization : Spaulding Hospital–Boston & Cambridge(SRN,SRH,SHC)

　　Schedule : Full-time

　　Standard Hours: : 40

　　Shift : Day Job

　　Employee Status : Regular

　　Recruiting Department: : SRH Research

　　Job Posting : Jan 19, 2024

　　Req ID: 3274152