Job Description

Steward Health Care System LLC ("Steward") is a fully integrated, physician-led national health care services organization committed to providing the highest quality of care in the most cost-efficient manner in the communities where our patients live. Steward - the largest privately held health care company in the U.S. - owns and operates 35 community hospitals across nine states, serves over 1,000 distinct communities and employs approximately 40,000 health care professionals. In addition to our hospitals, the Steward provider network includes 4,800 providers, 25 urgent care centers, 87 preferred skilled nursing facilities, substantial behavioral health offerings, over 7,300 hospital beds under management, and approximately 1.5 million full risk covered lives through the company's managed care and health insurance services.

Steward Medical Group (SMG), Inc. is Steward's multi-specialty group practice with over 4,500 employees including over 1,800 physicians and advanced practitioners. SMG operates approximately 450 practice locations throughout Massachusetts, Southern New Hampshire, Rhode Island, New Jersey, Pennsylvania, Ohio, Florida, Utah, Arizona, Texas, Louisiana and Arkansas, and provides more than 4 million patient encounters per year.

Overview:
The Research Program Manager will oversee and support research teams in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) in the Division of Pulmonology, Critical Care and Sleep Medicine. The Manager/Coordinator will be responsible for promoting and fostering the division’s research environment and also serve as the primary data collector and manager of subject clinical information as it pertains to participation in clinical trials. With this, the Manager/Coordinator will ensure timely collection of protocol related samples including shipment to outside entities as required. Additionally, the Manager/Coordinator will maintain regulatory binders and ensure study compliance with all state, federal, and IRB requirements. The Manager/Coordinator will be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). This individual may also screen patients for protocol eligibility and obtain informed consent. Limited travel may be required.


Responsibilities:
• Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
• Responsible for assisting in the recruitment of study participants.
• Assesses potential subjects and eligibility for inclusion in a particular protocol based on protocol requirements.
• Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.
• Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.
• Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.
• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
• Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.
• Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
• Interact with study participants as directed/required by the protocol and/or study team.
• Assist with preparation of abstracts, oral and/or poster presentations at major national meetings, and manuscripts for publication
• Oversee maintenance of research related databases for faculty and postdocs.
• Creates publication grade graphics and illustrations for faculty and postdocs.
• Contributes to the preparation of grant proposals included but not limited to protocol and budget development and IRB submission.
• Assist in training all new research personnel in compliance with all hospital, federal, state and local safety and regulatory compliance requirements.
• Foster relationships with industry sponsors of research in order to maintain funding for ongoing research.
• Participate actively in division staff meetings, research conferences and curriculum meetings in order to critique ongoing research and assist with and promote the group’s overall research efforts.

Qualifications:
• Bachelor's Degree required, with 2-3 years of related experience preferred. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.
• Excellent organization and communications skills required. Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts. Must be detail oriented and have the ability to follow-through. Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times. Must have computer skills including the use of Microsoft Office.
• IATA Hazardous Good Shipping Certification
• CITI Human Research Protection Certification
• High degree of organizational talents, data collection and analysis skills.
• Care in organization and systematic record-keeping.

Application Instructions

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